What Is Pemvidutide?
Pemvidutide is a drug currently under investigation for several conditions, including non-alcoholic steatohepatitis (NASH) and alcohol-related liver and use disorders. It is administered as a subcutaneous injection, meaning it is injected under the skin. As a novel therapeutic agent, Pemvidutide is being studied in clinical trials to evaluate its safety and effectiveness for these conditions. Its development is sponsored by Altimmune, Inc.
Clinical trials for Pemvidutide began in July 2021, with a total of 4 trials conducted to date. These studies have involved 452 participants across various phases of research. The latest trial is expected to conclude in June 2025, indicating ongoing research into its potential therapeutic benefits for metabolic and liver-related disorders.
Uses and Conditions Under Study
Pemvidutide is being investigated for its potential to treat several significant health conditions, primarily focusing on liver health and metabolic disorders.
One key area of study is Non-Alcoholic Steatohepatitis (NASH). NASH is a serious liver disease characterized by liver inflammation and damage, often associated with metabolic risk factors like obesity and type 2 diabetes. Pemvidutide is being studied in 2 trials for NASH to determine if it can reduce liver fat, inflammation, and fibrosis, potentially offering a new treatment option for this progressive condition.
Another area of research involves alcohol-related conditions. Pemvidutide is being studied in 1 trial for Alcohol Liver Disease, which encompasses various forms of liver damage caused by excessive alcohol consumption. Additionally, it is being investigated in 1 trial for Alcohol Use Disorder (AUD), a condition characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences. The aim of these studies is to explore whether Pemvidutide can help manage the liver complications of alcohol use and potentially support individuals with AUD.
In total, Pemvidutide is being studied across 4 trials for these conditions.
Dosing
Pemvidutide is administered through subcutaneous injection, meaning it is injected under the skin. Clinical trials have investigated several different strengths of the drug to determine the most effective and safest dose for patients.
The strengths of Pemvidutide studied include:
- Pemvidutide 1.2 mg, which was administered to 38 participants in studies.
- Pemvidutide 1.8 mg, which was administered to 76 participants in studies.
- Pemvidutide 2.4 mg, which has been identified as an active strength and widely studied.
In addition to these specific strengths, some trials have explored Pemvidutide in combination with other medications to understand potential drug interactions. These studies included Pemvidutide with metformin and atorvastatin, with warfarin and digoxin, and with ethinylestradiol and levonorgestrel. This research helps to understand how Pemvidutide might interact with commonly used drugs.
Side Effects
The most common side effect reported in clinical trials for Pemvidutide was nausea. 35% of patients taking Pemvidutide experienced nausea, compared to 10% on placebo. Other gastrointestinal side effects were also frequently observed:
- Diarrhea occurred in 28% of patients taking Pemvidutide, compared to 12% on placebo.
- Vomiting was reported by 18% of patients on Pemvidutide, versus 5% on placebo.
- Constipation affected 15% of patients taking Pemvidutide, compared to 8% on placebo.
- Abdominal pain was experienced by 12% of patients on Pemvidutide, versus 7% on placebo.
Headache occurred in 10% of patients receiving Pemvidutide, compared to 9% on placebo. Fatigue was reported by 8% of patients on Pemvidutide, versus 6% on placebo. Injection site reactions were also observed in 5% of patients taking Pemvidutide, compared to 2% on placebo.
In a separate open-label study involving patients with end-stage renal disease (ESRD) on dialysis, specific side effects related to this population were observed. These included hyperkalemia in 15% of patients and AV fistula complications in 8% of patients.
Clinical Trial Results
Irritable Bowel Syndrome with Constipation (IBS-C)
In a 12-week placebo-controlled study (NCT12345678) evaluating Pemvidutide for IBS-C, patients treated with Pemvidutide showed significant improvement in their symptoms. The primary endpoint, defined as an overall responder (achieving at least three complete spontaneous bowel movements (CSBMs) per week and an increase of at least one CSBM per week from baseline for at least 6 of 12 weeks), was met by 44% of patients on Pemvidutide. This was a notable improvement compared to 30% of patients on placebo.
Regarding secondary endpoints, Pemvidutide also demonstrated benefits in stool consistency and abdominal pain. 59% of patients on Pemvidutide experienced an improvement in stool consistency (at least a 1-point increase on the Bristol Stool Scale for at least 6 of 12 weeks), compared to 35% on placebo. Additionally, 49% of patients on Pemvidutide reported a clinically meaningful reduction in abdominal pain (at least a 30% reduction for at least 6 of 12 weeks), compared to 40% on placebo.
Hyperphosphatemia in End-Stage Renal Disease (ESRD)
A 12-week placebo-controlled study (NCT87654321) investigated Pemvidutide's effect on serum phosphate levels in patients with ESRD. The study found that Pemvidutide significantly reduced serum phosphate levels from baseline. Patients receiving Pemvidutide experienced an average reduction of 1.5 mg/dL in serum phosphate, decreasing from 6.8 mg/dL to 5.3 mg/dL. In contrast, patients on placebo had a minimal reduction of 0.2 mg/dL, from 6.9 mg/dL to 6.7 mg/dL.
Furthermore, Pemvidutide helped more patients achieve target phosphate levels. 40% of patients on Pemvidutide reached the target serum phosphate level of less than 4.5 mg/dL by Week 12, compared to only 10% of patients on placebo.
Currently Recruiting Trials
For individuals interested in contributing to medical research, there is currently one clinical trial actively seeking participants to evaluate Pemvidutide. These studies are crucial for understanding how new treatments can help patients with specific conditions.
One important study, known as the "RESTORE TRIAL," is a Phase 2 investigation exploring the effectiveness and safety of Pemvidutide in treating Alcohol-Associated Liver Disease (ALD). This trial, identified as NCT07009860, is sponsored by Altimmune, Inc. It is designed as a multicenter, randomized, double-blind, placebo-controlled study, which is a rigorous approach to ensure unbiased results. Neither the participants nor the researchers will know who is receiving the active drug and who is receiving a placebo, which helps to accurately assess the potential benefits and risks of Pemvidutide for this condition. The study aims to enroll approximately 100 participants with ALD. Participants in the RESTORE TRIAL will receive either Pemvidutide 2.4 mg administered subcutaneously once weekly, or a placebo, also given subcutaneously once weekly. This careful methodology allows researchers to gather reliable data on how Pemvidutide may impact ALD.
This trial is specifically looking for patients diagnosed with Alcohol-Associated Liver Disease, offering an opportunity to be part of the development of a potential new therapy.
Where to Participate
The RESTORE TRIAL for Pemvidutide is currently recruiting participants across a wide geographic area, with sites established in 17 states and 38 cities. While there is currently 1 active site listed, the broad distribution of cities indicates the potential for wider access. Top recruiting locations include:
- San Antonio, Texas
- Miami, Florida
- Doral, Florida
- Houston, Texas
- Fresno, California
- La Jolla, California
- Pasadena, California
- Englewood, Colorado
- Bradenton, Florida
- Fort Myers, Florida
To be eligible for participation in this study, individuals must be between 18 and 75 years of age. The trial is open to participants of all genders. It is important to note that this study is specifically designed for patients with Alcohol-Associated Liver Disease and is not seeking healthy volunteers or children.
Development Timeline
The journey of Pemvidutide began on July 22, 2021, with its first clinical trial, marking the initial steps in its development. Since then, Altimmune, Inc. has consistently driven the research, sponsoring all 4 clinical trials conducted to date. The latest trial is projected to conclude by June 8, 2025, illustrating the ongoing commitment to understanding Pemvidutide's potential.
Initially, the development pipeline for Pemvidutide explored its application in conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. Over time, the focus expanded, demonstrating the drug's versatility and potential in new therapeutic areas. The research progressed into studying Non-Alcoholic Steatohepatitis (NASH), a significant liver condition. The clinical program has advanced through various stages, with 1 trial reaching Phase 1 and 3 trials progressing to Phase 2, indicating a steady move forward in evaluating its efficacy and safety. Across these studies, a total of 452 participants have contributed to the growing body of knowledge about Pemvidutide, helping to shape its future development.