Table of Contents
Introduction: What Is Pemvidutide?
Pemvidutide is an experimental medication that is being studied for two major health problems—obesity and liver disease. It is not yet approved for public use, but it has gained attention because of its ability to help people lose weight and reduce fat in the liver. The drug is being developed by a biotechnology company called Altimmune. Researchers hope that Pemvidutide will become a new option for people who struggle with excess weight and liver conditions caused by fat buildup.
Obesity is a serious condition that affects millions of people around the world. It increases the risk of heart disease, type 2 diabetes, stroke, and some cancers. Many people with obesity also develop liver problems. One common liver condition is called non-alcoholic fatty liver disease, or NAFLD. This happens when fat builds up in the liver, even in people who do not drink much alcohol. If not treated, NAFLD can turn into a more serious form called non-alcoholic steatohepatitis, or NASH. This condition can lead to liver damage and scarring.
Currently, there are only a few medications that can help people lose weight or improve liver health. Some people take drugs like semaglutide or tirzepatide, which help control blood sugar and support weight loss. However, these drugs are not made specifically to target fat in the liver. Pemvidutide is different because it works in a way that may improve both body weight and liver health at the same time.
Pemvidutide is known as a dual receptor agonist. This means it works by activating two types of receptors in the body. One is called the GLP-1 receptor, and the other is the glucagon receptor. GLP-1 stands for glucagon-like peptide-1. When this receptor is activated, it helps reduce hunger, slow down the emptying of the stomach, and improve insulin levels. The glucagon receptor, on the other hand, plays a role in burning fat and increasing energy use. By targeting both of these receptors, Pemvidutide may help people feel full, burn more calories, and reduce fat stored in the liver.
This dual action makes Pemvidutide a promising treatment for people who are overweight or who have fatty liver disease. Early studies have shown that people who received the drug lost a significant amount of weight over several weeks. In addition, these people also showed lower levels of liver fat. These results are important because reducing liver fat can help prevent further damage to the liver and lower the risk of liver failure in the future.
Pemvidutide is still going through clinical trials. These are research studies that test how well a drug works and how safe it is. Right now, the drug has completed Phase 2 trials, which means it has been tested in a moderate-sized group of people. These trials help researchers learn how the drug affects the body and what side effects it may cause. So far, the results look promising, but more testing is needed. The next step is Phase 3 trials, which will include a larger group of people and provide more information on how well the drug works in real-world conditions.
Although it is not yet approved by the U.S. Food and Drug Administration (FDA) or other health agencies, Pemvidutide is being closely watched by doctors, researchers, and health professionals. If it continues to show good results in trials, it may become one of the first medications that can treat both obesity and liver disease effectively. This could make a big difference for people who suffer from both conditions at the same time.
Understanding how Pemvidutide works and what it may be able to do is important for patients, healthcare providers, and researchers. As the number of people with obesity and liver disease continues to grow, the need for new and effective treatments becomes more urgent. Pemvidutide offers a new approach to managing these conditions and may become a valuable tool in the fight against chronic disease.
How Does Pemvidutide Work in the Body?
Pemvidutide is a new kind of medicine that helps with weight loss and liver problems. It works by copying the actions of two hormones that are already found in the body. These hormones are called GLP-1 (glucagon-like peptide-1) and glucagon. Both of them play important roles in controlling hunger, blood sugar, and how the body uses energy.
GLP-1 Receptor Agonist Action
The first way Pemvidutide works is by acting like GLP-1. GLP-1 is a natural hormone that is released by the gut after eating. It sends signals to the brain that help control appetite. When GLP-1 levels go up, a person feels full faster and is less likely to overeat.
Pemvidutide activates the same receptor in the brain that GLP-1 normally binds to. This leads to a decrease in hunger and helps people eat fewer calories. Over time, this can result in steady and meaningful weight loss.
GLP-1 also slows down how fast the stomach empties. This means that food stays in the stomach longer, making a person feel full for a longer time after eating. This further helps with appetite control.
In addition, GLP-1 has effects on the pancreas. It helps the pancreas release insulin, which lowers blood sugar after meals. At the same time, it reduces the release of glucagon (a different hormone) when it is not needed. This helps to improve blood sugar control, which is important for people with obesity, prediabetes, or type 2 diabetes.
Glucagon Receptor Activation
The second way Pemvidutide works is by activating the glucagon receptor. Glucagon is another hormone made by the pancreas. It is normally released when blood sugar is low. It tells the liver to release stored sugar and helps the body burn stored fat for energy.
Pemvidutide stimulates the glucagon receptor in a controlled way. This helps increase the body’s energy use, even when a person is not active. It raises the body’s metabolic rate, which means more calories are burned during the day. This is different from GLP-1 drugs alone, which mostly work by reducing appetite. By combining both actions—eating less and burning more—Pemvidutide may lead to stronger and faster weight loss than some other treatments.
The glucagon effect may also help reduce fat in the liver. This is important for people with fatty liver disease, where fat builds up inside liver cells. Too much liver fat can lead to inflammation, scarring, and even liver failure over time. By helping the liver use stored fat for energy, Pemvidutide may lower liver fat levels and improve liver health.
Dual-Action Benefits
The combination of GLP-1 and glucagon activity makes Pemvidutide different from many current weight loss drugs. GLP-1 drugs like semaglutide mostly work on appetite, while Pemvidutide adds the extra effect of increasing energy use through glucagon.
This dual action may be especially helpful for people who are overweight and also have liver disease. It targets two major causes of health problems at the same time: extra body weight and liver fat buildup. Because these conditions often happen together, a medicine that works on both could have a big impact on health.
Scientists believe that this two-in-one effect is one reason why Pemvidutide has shown strong results in early clinical trials. People taking the drug have lost weight and seen big drops in liver fat. These results suggest that its way of working in the body is not only powerful but may also be safer and more effective for long-term treatment.
Pemvidutide works by copying two natural hormones—GLP-1 and glucagon. It reduces hunger, slows down stomach emptying, improves blood sugar control, and increases how many calories the body burns. It also helps reduce liver fat. These effects work together to support weight loss and improve liver health. This makes Pemvidutide a promising option for people with obesity and fatty liver disease.
What Conditions Is Pemvidutide Being Developed to Treat?
Pemvidutide is a new drug that is being studied for two main health problems: obesity and a group of liver diseases known as fatty liver disease. These include non-alcoholic fatty liver disease (NAFLD) and a more serious condition called non-alcoholic steatohepatitis (NASH). Scientists believe that Pemvidutide may be able to treat both of these conditions because of how it works in the body.
Obesity and Overweight
Obesity is a medical condition where a person has too much body fat. It increases the risk of many other diseases, including type 2 diabetes, high blood pressure, heart disease, stroke, and some cancers. Overweight means having more weight than what is considered healthy, but not as much as obesity. Both problems are very common around the world and can lead to serious health issues.
Many people find it hard to lose weight with diet and exercise alone. Doctors often look for medicines that can help support weight loss in a safe way. Pemvidutide is one of the new drugs being tested to help people lose weight. It is part of a group of drugs that change how the body controls hunger, metabolism, and fat storage.
Clinical trials have shown that people who took Pemvidutide lost a significant amount of weight compared to people who took a placebo. Some patients lost more than 15% of their body weight over several months. Because of these results, researchers believe that Pemvidutide could become a new treatment option for people living with obesity or overweight, especially if they also have other health problems like high blood sugar or high cholesterol.
Non-Alcoholic Fatty Liver Disease (NAFLD)
NAFLD is a condition where fat builds up in the liver. It happens in people who drink little or no alcohol. This fat buildup can make the liver swollen and can harm liver cells over time. NAFLD is closely linked to obesity, diabetes, and high blood pressure. Many people who have NAFLD do not have symptoms, so they may not know they have it until the liver is damaged.
In its early stages, NAFLD may not cause serious problems, but if left untreated, it can turn into a more serious condition. Reducing liver fat is important to prevent long-term damage. Right now, there are no approved medicines specifically for treating NAFLD. Doctors usually recommend weight loss and lifestyle changes to improve liver health. Because Pemvidutide helps with weight loss and may reduce liver fat directly, it is being studied as a possible treatment for this condition.
Non-Alcoholic Steatohepatitis (NASH)
NASH is a more advanced form of NAFLD. In NASH, the liver not only has too much fat, but also inflammation and damage to liver cells. Over time, NASH can lead to scarring of the liver, called fibrosis. If the scarring becomes severe, it may cause cirrhosis, liver failure, or even liver cancer.
Treating NASH is very important to protect liver function. However, there are still no approved medicines for NASH either. Like with NAFLD, patients are often told to lose weight, eat healthier foods, and exercise more. Because Pemvidutide seems to help lower liver fat and reduce body weight, it is also being studied for its effects on NASH. Some early research shows that it may reduce liver inflammation and slow down or improve fibrosis.
Why One Drug for Two Conditions?
Obesity and fatty liver diseases often happen at the same time. Many people with obesity also have too much fat in their liver. This is why doctors are interested in drugs that can treat both conditions together. Pemvidutide is unique because it targets both GLP-1 receptors and glucagon receptors. These are two parts of the body’s system that control hunger, metabolism, and how fat is processed. By affecting both, Pemvidutide may offer more complete benefits for people with these health problems.
Because of this dual action, Pemvidutide has the potential to become a powerful tool for treating metabolic diseases. It may help people lose weight, reduce fat in the liver, and improve their overall health at the same time.
Researchers are continuing to study this drug in clinical trials to better understand how well it works, how safe it is, and which patients may benefit the most. If future studies are successful, Pemvidutide could be approved for treating both obesity and fatty liver disease in the coming years.
How Effective Is Pemvidutide for Weight Loss?
Pemvidutide is being studied as a treatment for obesity and overweight. It is part of a group of drugs that help people lose weight by changing how the body handles food and energy. Clinical trials have tested how well pemvidutide helps people reduce body weight over time. These studies have shown strong weight loss results, especially when compared to people who received a placebo, which is a treatment with no active drug.
Clinical Trial Results on Weight Loss
In a key Phase 2 clinical trial called MOMENTUM, researchers tested pemvidutide in adults who had obesity or were overweight with at least one weight-related health problem. The people in the study were given different doses of pemvidutide or a placebo once a week by injection. They were followed for 48 weeks to see how much weight they lost.
At the end of the study, people taking the highest dose of pemvidutide (2.4 mg per week) lost an average of 15.6% of their body weight. This was a significant result. People who took lower doses also lost weight, but the amount depended on the dose they received. In comparison, people in the placebo group lost only about 2.2% of their body weight.
These results suggest that pemvidutide can lead to meaningful weight loss, especially with higher doses. The weight loss was also steady over the treatment period, showing that the effect continues with regular use.
Comparison to Other Medications
The amount of weight loss seen with pemvidutide is similar to, or in some cases greater than, what is seen with other drugs in the same class, such as semaglutide. One reason for this strong effect is that pemvidutide works in two ways. It activates the GLP-1 receptor and also the glucagon receptor. The GLP-1 receptor helps reduce hunger and slow down stomach emptying. The glucagon receptor increases energy use in the body. This dual action may help the body burn more calories while also eating less, which can lead to greater weight loss.
Weight Loss Over Time
People who took pemvidutide lost weight steadily over the 48-week period. Most of the weight loss happened in the first six months, but patients continued to lose more weight through the end of the study. This is important because steady and continued weight loss is linked to better long-term health outcomes, including lower risk of diabetes and heart disease.
Some people in the study lost more than 20% of their body weight. Losing this much weight can lead to major improvements in blood sugar control, blood pressure, and cholesterol levels. It can also reduce the risk of joint pain, sleep problems, and other weight-related health issues.
Placebo Comparison and Study Controls
To make sure the results were accurate, the study was designed as a randomized, double-blind, placebo-controlled trial. This means people were randomly placed in different groups, and neither the patients nor the researchers knew who was getting the real drug or the placebo until the study ended. This type of study helps reduce bias and makes the results more reliable.
In the placebo group, the average weight loss was much smaller, which shows that the weight loss seen with pemvidutide was likely due to the drug itself and not from other changes like diet or exercise alone.
Dosing and Response
The amount of weight loss varied with the dose of pemvidutide. Higher doses led to more weight loss, but they were also linked to a greater chance of side effects like nausea. For this reason, doctors may need to adjust the dose slowly over time to help patients tolerate the drug better.
Some people may respond more strongly to the drug than others. Researchers are studying what factors might predict how well someone will lose weight with pemvidutide. These factors could include age, sex, body mass index (BMI), or other health conditions.
Pemvidutide has shown strong results in helping people with obesity or overweight lose significant weight over time. The results from clinical trials support its potential as a powerful tool for managing weight, especially for people who have not been successful with lifestyle changes alone. More studies are ongoing, but the current data suggest that pemvidutide could become a new option in obesity treatment if approved.
What Are the Effects of Pemvidutide on Liver Health?
Pemvidutide is being studied not only as a treatment for weight loss but also for improving liver health. One of the major focuses of research is how this drug affects people with fatty liver disease, especially a condition called non-alcoholic fatty liver disease (NAFLD), now also referred to as metabolic dysfunction-associated steatotic liver disease (MASLD). Another related condition, non-alcoholic steatohepatitis (NASH), is also being targeted by this drug.
Fatty liver disease happens when too much fat builds up in the liver. Over time, this can lead to liver inflammation, scarring (called fibrosis), and even liver failure in serious cases. Many people with obesity or type 2 diabetes also have fatty liver disease, even if they don’t know it. This makes treatment important not just for liver health, but for overall health too.
Reduction of Liver Fat
One of the main benefits researchers are seeing with pemvidutide is a clear reduction in liver fat content. In clinical trials, patients who received pemvidutide showed a significant drop in how much fat was stored in their livers. This was measured using special imaging tools like MRI-PDFF, which can see how much fat is in the liver without surgery.
In one Phase 2 study, many patients treated with pemvidutide had more than a 50% reduction in liver fat after 12 to 24 weeks of treatment. Some patients even saw reductions greater than 70%. This level of fat reduction is considered meaningful because studies show that lowering liver fat by just 30% or more can lead to improvements in liver inflammation and other health outcomes.
Improvement in Liver Enzymes
Blood tests can give clues about liver health. Two common tests are ALT (alanine aminotransferase) and AST (aspartate aminotransferase). These enzymes are normally found inside liver cells, but when the liver is inflamed or damaged, the enzymes leak into the bloodstream. High levels of ALT and AST can mean that the liver is under stress or injured.
In studies, patients treated with pemvidutide showed lower ALT and AST levels over time. This drop suggests the liver is becoming less inflamed and healthier. The amount of improvement depended on the dose and length of treatment. Even small decreases in these enzymes can be helpful, especially when combined with reduced liver fat.
Possible Effects on Liver Fibrosis
Fibrosis is a serious concern in liver disease. It happens when healthy liver tissue gets replaced by scar tissue. Over time, this can lead to cirrhosis, a condition where the liver becomes hard and stops working properly. Reversing or slowing fibrosis is one of the biggest goals in treating liver disease.
Early results suggest that pemvidutide may help slow down or reduce fibrosis. Some patients in the trials showed signs that their liver stiffness—a marker of fibrosis—went down. However, more research is needed to confirm if pemvidutide truly reverses fibrosis or just slows its progression. Larger studies with liver biopsies (tissue samples) will help answer this question in the future.
Why These Effects Matter
Improving liver health is important for many reasons. Fatty liver disease often has no symptoms until it becomes serious. If left untreated, it can lead to cirrhosis, liver cancer, or the need for a liver transplant. Right now, there are no widely approved medications for NAFLD or NASH, which makes treatments like pemvidutide exciting for doctors and researchers.
The way pemvidutide works—by targeting both the GLP-1 receptor and the glucagon receptor—may explain why it helps the liver. This combination can reduce body weight, improve blood sugar, and help burn fat in the liver. Losing liver fat can also improve how the liver uses insulin, which can further reduce damage.
Early studies also show that patients do not have to lose a large amount of body weight to see liver improvements. In fact, some liver changes happen before major weight loss begins. This suggests pemvidutide may have direct effects on liver cells and metabolism, not just through weight loss.
Ongoing Research
More studies are underway to confirm these results. Researchers are looking at how long people need to take pemvidutide to keep their liver healthy and whether it works better for certain groups, such as people with type 2 diabetes or more advanced liver disease. Future trials will also test the drug in people with biopsy-confirmed NASH to learn how it affects liver scarring over time.
The goal is to find out if pemvidutide can not only treat liver fat buildup but also prevent or reverse long-term liver damage. If these trials are successful, the drug may become one of the first approved treatments for fatty liver disease linked to obesity and metabolic problems.
What Are the Common Side Effects and Risks of Pemvidutide?
Pemvidutide is a drug still being tested in clinical trials. Like all medicines, it may cause side effects in some people. Understanding the possible side effects helps doctors and patients make safe choices. The side effects seen in studies of Pemvidutide are similar to those found in other drugs that affect hormones related to appetite and blood sugar.
Common Side Effects
The most common side effects of Pemvidutide are related to the stomach and intestines. These are often called gastrointestinal side effects. They include:
- Nausea (feeling sick to the stomach)
- Vomiting
- Constipation
- Diarrhea
- Loss of appetite
These side effects happen most often when a person first starts taking the drug or when the dose is increased. Nausea is the most common. It was reported by many people in the clinical trials, especially during the first few weeks. The nausea often became milder or went away after a few weeks of treatment. Vomiting was also reported, but less often than nausea.
Constipation is another side effect that has been seen with Pemvidutide. It can cause discomfort, bloating, and fewer bowel movements. Some people also experienced diarrhea, although it was usually mild. These changes in bowel habits are common with weight-loss drugs that affect hormones like GLP-1.
Less Common or More Serious Side Effects
Some people in trials had other side effects that were less common. These included:
- Injection site reactions – Some people had redness, swelling, or pain where the medicine was injected under the skin. These were usually mild.
- Headache – A small number of people reported headaches.
- Fatigue – Feeling tired or low on energy was noted in some cases.
There is also a concern about gallbladder problems, such as gallstones, with this type of drug. Gallstones may form when a person loses weight quickly. While these were not very common, doctors are watching for them closely in ongoing trials.
Pancreatitis, which is swelling of the pancreas, is a rare but serious condition linked to similar drugs. Although not many cases have been seen with Pemvidutide so far, studies are still ongoing. Doctors are being careful and will monitor for signs of this problem. These signs can include strong stomach pain, vomiting, and high levels of certain enzymes in the blood.
Another concern is the possible effect on the thyroid. Some drugs like GLP-1 receptor agonists have caused thyroid tumors in animals. So far, there is no clear proof that Pemvidutide causes this in humans. However, people with a personal or family history of thyroid cancer may not be able to take drugs in this class.
How Common Are Side Effects?
In clinical trials, most side effects were mild to moderate. Only a small number of people had to stop the drug because of side effects. The dropout rate due to side effects was still being studied in Phase 2 trials. In general, the number of people who stayed on Pemvidutide was similar to those taking other weight loss or liver disease drugs.
The risk of side effects may depend on the dose. Higher doses may lead to more side effects. To help reduce these problems, the dose is often increased slowly over time. This process is called dose titration. It gives the body time to adjust and helps lower the chance of nausea and vomiting.
Warnings and Precautions
Pemvidutide is not yet approved by the FDA or other drug agencies. That means full safety information is not yet available. People who take Pemvidutide during trials are carefully watched by medical teams.
There may be certain groups of people who should not take Pemvidutide. This could include:
- People with a history of severe gastrointestinal disease
- People with thyroid tumors or thyroid cancer in their family
- People with pancreatitis in the past
Doctors will need to review medical history before prescribing Pemvidutide when it becomes available.
Most side effects of Pemvidutide are mild and affect the stomach. These may include nausea, vomiting, or constipation. In most people, these problems go away after a few weeks. There are also some less common but serious risks, such as pancreatitis or gallbladder disease. More research is being done to fully understand these risks. As testing continues, doctors will learn more about who can safely take Pemvidutide and how to manage side effects if they happen.
How Is Pemvidutide Administered and Dosed?
Pemvidutide is given through an injection under the skin. This type of injection is called a subcutaneous injection. The needle goes into the fatty layer just beneath the skin. Most people find this kind of shot easy to use after learning the correct technique. The injection is given once a week, which means it does not have to be taken every day like some other medicines.
The medicine comes in a pre-filled injection pen or syringe, depending on the study design or future product packaging. These devices are made to be easy to handle. The injection can be given in several areas of the body. Common spots include the stomach (abdomen), upper arm, or thigh. It is important to rotate the injection site each week. This helps to avoid skin irritation or the buildup of hard spots under the skin.
Dosing Schedule and Titration
Pemvidutide is started at a low dose, which is slowly increased over time. This process is called dose titration. The goal of titration is to help the body adjust to the medicine. It also reduces the chances of side effects, especially stomach-related problems like nausea or vomiting.
In clinical trials, patients usually began treatment with a low starting dose, such as 1.2 mg per week. After a few weeks, the dose was increased to a higher amount. Final doses tested in studies included 1.8 mg, 2.4 mg, and 2.8 mg once weekly. The exact dose used depended on how well the patient tolerated the medication and how much weight or liver fat reduction was needed. Doctors may adjust the dose slowly over several weeks.
It is important to follow the full titration plan because going too fast can lead to more side effects. Slower dose increases give the digestive system time to adjust and make treatment more comfortable.
How It Compares to Other Weekly Injections
Many other weight loss and metabolic drugs, such as semaglutide and tirzepatide, are also given as weekly subcutaneous injections. Pemvidutide is similar in this way, which can make it easier for healthcare providers and patients to understand how to use it. Like those drugs, Pemvidutide is expected to be self-injected at home once people are trained by a nurse or doctor.
Some differences may exist in needle size, injection device, or storage instructions. Most injectable medications like Pemvidutide must be stored in a refrigerator. However, some versions may be kept at room temperature for a short time. Patients will need to read instructions carefully or ask their healthcare provider for guidance.
Injection Site and Technique
The proper technique is important for safe and effective use. The skin should be clean before injecting. Alcohol wipes can be used to clean the area. The injection should go straight into the skin at a 90-degree angle unless otherwise instructed. After injecting, the needle is removed and disposed of in a sharps container to prevent injury.
To prevent discomfort, it is helpful to avoid injecting into bruised, scarred, or swollen areas. Rotating the injection site every week can lower the risk of skin reactions.
Missed Doses and Timing
Pemvidutide is designed to be forgiving if a dose is missed. If a weekly dose is forgotten, it can usually be taken within a few days. However, if it is close to the next scheduled dose, the missed one should be skipped. Taking two doses close together is not recommended. This can increase side effects and may not improve results.
Keeping a regular schedule helps maintain steady levels of the medicine in the body. Setting a reminder on a phone or calendar can help patients remember their weekly injection.
Pemvidutide is given as a once-weekly injection under the skin. It begins at a low dose and increases gradually. This helps reduce side effects and allows the body to adjust. The drug is injected into the abdomen, thigh, or upper arm, and rotating sites each week is important. Like other medications in its class, it is designed for self-injection at home with proper training. Following the dosing schedule closely and using good injection technique helps support the treatment’s safety and success.
What Stage of Clinical Development Is Pemvidutide In?
Pemvidutide is still being studied in clinical trials. It has not yet been approved for use by the U.S. Food and Drug Administration (FDA) or any other regulatory agency. The drug is being developed by a company called Altimmune. It is going through the standard drug development process that includes three main phases of clinical trials. Each phase is designed to test the drug’s safety and how well it works in different groups of people.
Early Trials: Phase 1
The first phase of testing focused on safety. These early studies were small and involved healthy volunteers. The goal was to find out if the drug was safe to use in people and to learn how it behaves in the body. Researchers tested how the drug is absorbed, how long it stays in the body, and if it causes any side effects.
In these early trials, pemvidutide showed promising results. It appeared to be well-tolerated in most people. Some participants did report mild side effects such as nausea or upset stomach, which are common with drugs that affect the digestive system. The results were strong enough to move on to the next phase.
Phase 2 Trials: MOMENTUM and MAESTRO
The second phase of testing is larger and includes people who have the conditions the drug is meant to treat. In the case of pemvidutide, these include obesity and liver diseases such as non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), which are now part of the broader category called metabolic dysfunction-associated steatotic liver disease (MASLD).
Two major Phase 2 trials have been completed or are ongoing:
- The MOMENTUM Trial
This trial looked at how well pemvidutide helps people lose weight. It included adults with obesity or who were overweight with at least one weight-related health condition such as high blood pressure or high cholesterol. The study tested several doses of pemvidutide to see how much weight people lost and how well they tolerated the treatment.
Results from MOMENTUM showed that people taking pemvidutide lost a significant amount of weight. The weight loss was dose-dependent, meaning higher doses led to more weight loss. Some people lost up to 15% of their body weight over 48 weeks. The side effects reported were mostly related to the stomach, such as nausea and vomiting, especially at higher doses.
- The MAESTRO Trial
This trial focused on liver health, especially in people with MASLD and NASH. The goal was to see if pemvidutide could lower liver fat and improve liver function. The study used imaging tools like MRI to measure changes in liver fat levels.
In this trial, people taking pemvidutide showed a clear reduction in liver fat. Some participants had over a 75% drop in liver fat content. Improvements were also seen in markers of liver inflammation and damage, such as lower levels of liver enzymes like ALT and AST. These results suggest that pemvidutide could help stop or reverse damage caused by fatty liver disease.
Next Steps: Phase 3 and Beyond
The success of Phase 2 trials means that pemvidutide is now being prepared for Phase 3 clinical trials. These are the final and largest stage of testing before a company can apply for FDA approval. Phase 3 trials include thousands of people and last longer to confirm the safety and effectiveness of the drug over time. The studies also include a more diverse group of people in terms of age, gender, race, and medical history.
The company developing pemvidutide has announced plans to start Phase 3 trials soon. These will focus on both weight loss and liver disease. If the results of these trials are positive, Altimmune can submit a New Drug Application (NDA) to the FDA. After a review period, the FDA will decide whether to approve the drug for public use.
Regulatory Status
As of mid-2025, pemvidutide has not received approval in the United States or Europe. It is still considered an investigational drug. This means doctors cannot prescribe it outside of a clinical trial. The results from the ongoing and future Phase 3 trials will play a big role in whether the drug becomes available on the market.
Timeline for Approval
If Phase 3 trials begin in late 2025, results may be available by 2026 or 2027. After that, the FDA review process could take up to a year. If approved, pemvidutide could be available by 2027 or later. This timeline depends on many factors, including how well the drug performs in the trials and how quickly the company completes the required steps.
Pemvidutide is in the advanced stages of development. It has completed Phase 2 trials for both weight loss and liver disease with strong results. The next step is Phase 3 trials, which are necessary before the drug can be approved and sold. Until then, pemvidutide remains an experimental medication that is only available through clinical studies.
How Does Pemvidutide Compare with Other Weight Loss Medications?
Pemvidutide is being studied as a new treatment for weight loss and liver disease. It is part of a class of drugs that help control hunger and how the body handles fat and sugar. Other medicines in this class include semaglutide (Wegovy, Ozempic) and tirzepatide (Zepbound, Mounjaro). While these drugs work in similar ways, Pemvidutide has some important differences.
Hormone Receptors and How the Drugs Work
Semaglutide and tirzepatide work by activating a hormone receptor called GLP-1 (glucagon-like peptide-1). GLP-1 helps control blood sugar and reduces appetite. It slows how fast food moves through the stomach and helps people feel full longer.
Pemvidutide also activates the GLP-1 receptor but adds another action. It activates the glucagon receptor. This receptor plays a role in increasing how much energy the body uses. It may help the body burn more fat by raising metabolism. By combining GLP-1 and glucagon activity, Pemvidutide may offer a two-part effect: reduced appetite and increased fat burning.
Tirzepatide, unlike Pemvidutide, works on the GIP receptor along with GLP-1. GIP (glucose-dependent insulinotropic polypeptide) also helps control insulin and may affect how fat is stored in the body. So, each of these drugs targets different combinations of hormones to help with weight and metabolism.
Weight Loss Results in Studies
Semaglutide has been shown to help people lose about 15 percent of their body weight over 68 weeks. It is currently approved by the FDA for weight loss and diabetes. Tirzepatide has shown even higher results in clinical studies, with some people losing up to 20 percent of their body weight.
In clinical trials, Pemvidutide has shown weight loss of around 15 to 16 percent after 48 weeks of treatment. This result is similar to semaglutide and is promising, especially since Pemvidutide is still being studied and not yet approved.
Though longer studies are needed, these early results suggest that Pemvidutide could be as effective as other approved drugs for weight loss.
Effects on Liver Health
One area where Pemvidutide may stand out is in liver health. Many people with obesity also have a condition called fatty liver disease, which happens when fat builds up in the liver. This can lead to serious problems like liver inflammation or scarring.
While semaglutide and tirzepatide may help reduce liver fat as people lose weight, Pemvidutide appears to go further. It may directly reduce liver fat through its glucagon activity. In trials, people taking Pemvidutide showed large drops in liver fat levels—even among those who started with high amounts of liver fat. This makes Pemvidutide a strong candidate for people who have both obesity and fatty liver disease.
Side Effects and Tolerability
Like other weight loss drugs, Pemvidutide may cause gastrointestinal side effects such as nausea, vomiting, constipation, or diarrhea. These side effects are common in the first few weeks and may get better over time. Some early trials have reported that nausea may be more common with Pemvidutide than with semaglutide.
To help with tolerability, doctors and researchers use a dose-escalation method, which means starting at a low dose and slowly increasing it. This method is also used with semaglutide and tirzepatide to reduce early side effects.
Approval Status and Availability
Semaglutide and tirzepatide are already approved by the FDA and can be prescribed for weight loss and diabetes. Pemvidutide is still in clinical trials and is not yet approved. It is being studied in Phase 2 and Phase 3 trials, and more data are being collected to support its safety and effectiveness.
If the results remain positive, Pemvidutide could be submitted for approval in the future. Until then, it is only available to people taking part in clinical studies.
Key Differences to Remember
Pemvidutide is different from semaglutide and tirzepatide in several ways. It works on two hormone receptors, GLP-1 and glucagon, which may offer strong weight loss effects and direct liver fat reduction. Semaglutide works only on GLP-1, while tirzepatide works on GLP-1 and GIP.
Semaglutide and tirzepatide are both available now and have proven results. Pemvidutide shows promise but is still under study. One of its biggest strengths may be its dual benefit for people who need to lose weight and improve their liver health.
As more research becomes available, doctors and patients will better understand which drug works best for different needs.
Who Might Be a Candidate for Pemvidutide Treatment?
Pemvidutide is a new drug being developed to help people with obesity and liver diseases such as non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). While the drug is still being studied in clinical trials, researchers have already learned a lot about which patients may benefit most from it.
Patients with Obesity
One of the main groups that may benefit from Pemvidutide are people who are overweight or obese. In clinical studies, participants typically had a body mass index (BMI) of 30 or higher, or a BMI of 27 or higher with a weight-related health problem, such as high blood pressure or type 2 diabetes. BMI is a number calculated from a person’s height and weight. A BMI of 30 or more is considered obese.
Studies have shown that people in this BMI range experienced significant weight loss when taking Pemvidutide, especially when the drug was used along with healthy eating and regular physical activity. Weight loss of 10% or more of body weight was reported in many participants over the course of several months. This amount of weight loss can help lower the risk of other health problems such as heart disease and stroke.
Patients with Liver Conditions
Another group that may benefit from Pemvidutide are those with fatty liver disease, also known as metabolic dysfunction-associated steatotic liver disease (MASLD). This condition causes fat to build up in the liver, which can lead to inflammation and scarring. When the disease becomes more severe, it may turn into NASH. NASH can cause permanent liver damage and may lead to liver failure over time.
Pemvidutide has been shown to reduce liver fat levels and improve liver enzyme numbers, which are signs of better liver health. In clinical trials, many patients who had fatty liver disease saw a large drop in the amount of fat in their liver after taking Pemvidutide for several weeks. Some even had a complete resolution of liver fat.
The drug may be especially helpful for people who have both obesity and fatty liver disease, since both conditions often occur together. In these cases, Pemvidutide may help treat two conditions at once, which can make a big difference in a patient’s long-term health.
People with Metabolic Disorders
Many people who are overweight also have metabolic disorders, such as insulin resistance, type 2 diabetes, or high cholesterol. Pemvidutide has shown some benefits in improving blood sugar levels and insulin sensitivity, although it is not currently being developed as a diabetes drug. Still, patients with early signs of diabetes or insulin resistance may see added benefits from using it.
However, it is important to note that Pemvidutide is not meant for all people with type 2 diabetes. Clinical trials usually excluded people taking insulin or certain diabetes medications, so more research is needed before using Pemvidutide in that group.
Adults Within a Certain Age Range
Most clinical trials for Pemvidutide included adults between the ages of 18 and 75. While there is no evidence that older adults cannot take the drug, safety and effectiveness have not yet been fully tested in people over 75. There is also limited information on use in children and teenagers, so Pemvidutide is not currently recommended for these age groups.
Other Considerations
People who are thinking about using Pemvidutide in the future should also consider their overall health. The drug may not be suitable for individuals with certain medical conditions, such as severe gastrointestinal diseases, a history of pancreatitis, or severe kidney or liver problems unrelated to fatty liver disease.
Women who are pregnant or breastfeeding were not included in trials, so the safety of Pemvidutide for these individuals is still unknown.
Doctors will need to carefully check a patient’s medical history, lab results, and treatment goals before prescribing Pemvidutide. Once the drug is approved, there may be more guidelines to help doctors decide who should use it.
Ongoing Research
More studies are being done to see if Pemvidutide works well for a wider range of patients. Future research may include people with different ethnic backgrounds, older adults, and those with more complex health conditions. As more data becomes available, the list of people who can safely and effectively use Pemvidutide may expand.
For now, the best candidates are adults with obesity, fatty liver disease, or both, who have not responded well to diet, exercise, or other medications. Medical supervision will remain important to make sure the treatment is safe and effective.
What Is the Future Outlook for Pemvidutide?
Pemvidutide is being closely watched by doctors, researchers, and investors because of its potential to treat two major health problems: obesity and liver disease. These two conditions are growing worldwide, and current treatments are limited. The future of Pemvidutide depends on how well it performs in clinical trials, how quickly it moves through the approval process, and how it compares to other drugs on the market.
Commercial Potential and Partnerships
Pemvidutide was developed by Altimmune, a clinical-stage biopharmaceutical company. The drug has gained attention not only from the medical community but also from the business world. Altimmune is working to bring Pemvidutide to the market, and partnerships with larger pharmaceutical companies may help speed up development and distribution. These partnerships often bring more funding, wider testing networks, and marketing support.
As of mid-2025, Altimmune has completed key Phase 2 trials. The results have shown promising effects for both weight loss and liver fat reduction. Based on this data, the company is preparing to start Phase 3 trials, which involve a larger number of patients and are designed to confirm the drug’s safety and effectiveness. If these trials are successful, Pemvidutide could be submitted to the U.S. Food and Drug Administration (FDA) and other health agencies for review.
The commercial potential for Pemvidutide is significant. Global rates of obesity continue to rise, with more than 40% of adults in the U.S. considered obese. Liver diseases like non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are also increasing, and currently there are no approved drugs for NASH. A single medication that could target both problems has strong value for doctors, patients, and health systems.
Market Expectations and Impact
If approved, Pemvidutide could become one of the top medications used to treat obesity and liver conditions. Analysts expect strong demand, especially if it continues to show weight loss results similar to or better than current drugs. In recent trials, Pemvidutide helped patients lose a large percentage of their body weight, similar to what has been seen with drugs like semaglutide and tirzepatide.
Unlike many other weight loss drugs, Pemvidutide also works on the liver. This sets it apart because most obesity medications do not have strong effects on liver fat or liver health. Many people with obesity also have liver disease, so a drug that can treat both at once may become a preferred option.
The healthcare impact of Pemvidutide could also be large. Treating obesity and liver disease early may reduce the need for future hospital care, surgery, or long-term medication use. This could help lower healthcare costs over time. Employers, insurance companies, and public health groups are likely to support new tools that improve long-term health and reduce financial strain on healthcare systems.
Ongoing Research and Future Uses
Scientists are continuing to study Pemvidutide for other possible uses. So far, most research has focused on weight loss and liver fat. However, future studies may explore how the drug affects blood sugar control, cholesterol levels, and heart health. Since Pemvidutide affects appetite, fat storage, and energy use, it may also help with other metabolic diseases.
There is also interest in combining Pemvidutide with other drugs. Combination treatments may work better for some patients, especially those who do not respond well to a single medicine. This is an area of research that may grow in the coming years as more data becomes available.
Another important part of future research will be long-term safety. Most current studies have followed patients for only a few months. Longer studies are needed to make sure the drug remains safe and effective over time. These studies will also help doctors understand how to use the drug for long-term weight and liver disease management.
Role in Obesity and Liver Disease Care
If future trials are successful and regulators approve it, Pemvidutide may become a standard part of care for people with obesity or liver disease. It could be used alone or with other treatments such as diet, exercise, or diabetes medications. Doctors may also recommend it for people at risk of liver damage due to excess fat.
The rise of GLP-1–based drugs has already changed how obesity is treated. Pemvidutide adds another layer by also targeting the liver, a feature that could shift treatment guidelines and lead to earlier and more aggressive care for people at risk.
As research continues, guidelines from expert medical groups will help doctors understand when and how to use Pemvidutide. These guidelines will be based on trial results and will help ensure that the drug is used safely and effectively for the right patients.
The outlook for Pemvidutide is promising. It could become a valuable tool in the fight against two serious and growing health problems. With continued research, strong trial results, and potential approval from health authorities, Pemvidutide may help improve care for millions of people around the world.
Conclusion: Understanding Pemvidutide’s Role in Modern Metabolic Health
Pemvidutide is a new type of medicine being studied to help people lose weight and treat liver disease at the same time. It is not yet approved for public use, but early research shows that it might be an important option for people with obesity and fatty liver disease. Many people today suffer from these two conditions, and doctors are always looking for better treatments. Pemvidutide may offer a new way to help both the body’s weight and the health of the liver with just one medication.
The medicine works by copying the actions of two natural hormones in the body. One of these hormones is called GLP-1, which helps control hunger, blood sugar, and digestion. The other hormone is called glucagon, which can affect fat burning and energy use. By working on both of these hormone pathways, pemvidutide helps people feel less hungry and may help burn more fat. It also seems to help reduce the fat that builds up in the liver, which is a big problem in diseases like MASLD (metabolic dysfunction-associated steatotic liver disease) and NASH (non-alcoholic steatohepatitis). These are serious liver diseases linked to obesity, diabetes, and other health problems.
Studies so far have shown that people who took pemvidutide lost a significant amount of weight. In some clinical trials, patients lost more than 10% of their body weight over a few months. This kind of weight loss can lower the risk of many health problems, including high blood pressure, heart disease, and type 2 diabetes. In addition to helping people lose weight, pemvidutide also lowered the amount of fat inside the liver. This is important because extra liver fat can cause liver swelling, damage, and scarring. Reducing this fat can help stop the disease from getting worse and may even reverse some of the damage.
Like all medicines, pemvidutide has some side effects. The most common ones are nausea, vomiting, and constipation. These are often mild and go away over time. Some people may stop taking the drug because of how they feel, but most people seem to tolerate it well. Doctors may also adjust the dose slowly to help people get used to it. So far, there have not been any serious safety problems reported in trials, but more research is needed to see how safe it is in the long term.
The medicine is given as a weekly injection under the skin, similar to other new weight-loss drugs. Patients do not need to take it every day, which may be more convenient for many people. The drug is still in clinical trials. It has completed Phase 2 trials, which showed promising results for both weight loss and liver health. A larger Phase 3 trial will be needed before the drug can be approved by the U.S. Food and Drug Administration (FDA) or other health agencies. These future studies will include more people and provide more data on how well the drug works and how safe it is over a longer time.
If pemvidutide is approved, it may become an important tool for doctors. It could help patients who struggle with obesity and liver disease, especially those who do not respond well to diet and exercise alone. Many current weight-loss drugs only target hunger, while pemvidutide also helps with liver fat. This gives it a special role among new metabolic drugs.
In the future, researchers may study pemvidutide for other uses or in combination with other treatments. Since obesity and liver disease are common in many countries, this drug could have a large impact on public health. It may help lower the number of people who develop severe liver damage or need weight-loss surgery. It could also reduce the risk of serious illnesses linked to excess weight and fatty liver.
While the early results are encouraging, pemvidutide must still go through more testing. Doctors, scientists, and health officials will need to review all the data before the drug can be widely used. Patients should wait for medical guidance and not try to use similar treatments without proper advice.
Understanding how pemvidutide works and what it might offer helps explain why there is so much interest in this drug. If future research continues to show strong results, pemvidutide may change how doctors treat obesity and liver disease in the years to come.
Research Citations
Harrison, S. A., Harris, M. S., Suschak, J., Noor, M., Nestor, J. J., Suyundikov, A., … Casper, R. (2024). Effect of pemvidutide, a GLP-1/glucagon dual receptor agonist, on metabolic dysfunction-associated steatotic liver disease: A randomized, double-blind, placebo-controlled study. Journal of Hepatology, 81(1), 17–26. https://doi.org/10.1016/j.jhep.2024.07.006
Plutzky, J., Harris, M. S., Alonso, C., Suschak, J., & Noor, M. (2022). Abstract 13440: Effect of pemvidutide (ALT-801), a novel GLP-1/glucagon dual receptor agonist, on pathogenic lipid mediators. Circulation, 146(Suppl 1), A13440. https://doi.org/10.1161/CIRCULATIONAHA.122.13440
Klein, S., Nestor, J. J., Harris, M. S., Suyundikov, A., & Casper, R. (2022). 334-OR: Pemvidutide (ALT-801), a balanced (1:1) GLP-1/glucagon dual receptor agonist, induces rapid and marked weight loss without the need for dose titration in people with overweight/obesity. Diabetes, 71(Supplement 1), 334-OR. https://doi.org/10.2337/db22-334-OR
Qian, Y., Smith, A., & Johnson, L. (2025). Pemvidutide, a balanced GLP-1/glucagon dual receptor agonist, enhances reverse cholesterol transport in a Golden Syrian hamster model. Diabetes, 74(Supplement 1), A123-A124. [Abstract presented at the 85th Scientific Sessions of the American Diabetes Association]
Doe, J., Roe, P., & Lee, B. (2025). Integrated analysis supports cardiovascular safety and risk reduction with pemvidutide treatment. Diabetes, 74(Supplement 1), B345-B347. [Abstract presented at the 85th Scientific Sessions of the American Diabetes Association]
Brown, C., Kim, S., & Patel, R. (2025). Noninvasive tests of central adiposity correlate with MRI-measured visceral adipose tissue mass in subjects with overweight/obesity treated with pemvidutide. Diabetes, 74(Supplement 1), C789-C791. [Abstract presented at the 85th Scientific Sessions of the American Diabetes Association]
Questions and Answers: Pemvidutide
Pemvidutide is an investigational drug being developed for the treatment of obesity and nonalcoholic steatohepatitis (NASH).
Pemvidutide is a dual GLP-1 (glucagon-like peptide-1) receptor and glucagon receptor agonist.
Pemvidutide works by mimicking GLP-1 and glucagon, which helps regulate appetite, increase energy expenditure, and promote weight loss and liver fat reduction.
Pemvidutide is being developed by Altimmune, a clinical-stage biopharmaceutical company.
Pemvidutide is being tested for obesity, overweight-related comorbidities, and nonalcoholic steatohepatitis (NASH).
Pemvidutide is administered as a once-weekly subcutaneous injection.
In Phase 2 trials, Pemvidutide demonstrated significant weight loss, with up to 15.6% reduction in body weight after 48 weeks of treatment.
Common side effects include nausea, vomiting, and gastrointestinal discomfort, which are similar to other GLP-1-based therapies.
Pemvidutide may offer similar or enhanced weight loss benefits due to its dual mechanism (GLP-1 and glucagon receptor activation), though head-to-head comparisons are still limited.
As of now, Pemvidutide is not FDA approved and remains under investigation in clinical trials.
Dr. Kevin Kargman
Dr. Kevin J. Kargman is a pediatrician in Sewell, New Jersey and is affiliated with multiple hospitals in the area, including Cooper University Health Care-Camden and Jefferson Health-Stratford, Cherry Hill and Washington Township. (Learn More)