A study testing whether a new weekly shot from Altimmune, pemvidutide, can improve fatty liver disease.

Who can join

Adults 18 to 75, have alcohol-related liver disease, BMI 25+.

What you take

pemvidutide, given as part of the study at no cost to you. Some participants may receive a placebo (an inactive version) instead, decided at random.

How long it lasts

The full study runs about 2.2 years; your own time in it is usually shorter.

What you get

The study medication and study-related care at no cost. Compensation varies by study site; many cover travel and provide the study medication at no cost. The trial coordinator will explain what that site offers before you join.

What this study is for

Full study title: RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD).

Primary condition: Alcohol Liver Disease.

Who can join, in detail

Key inclusion criteria

• Male or female ages 18 to 75 years, inclusive
• Overweight or obesity, defined as BMI >= 25 kg/m2
• History of alcohol misuse for the prior 3 years, with an alcohol intake >= 50 grams per day for males and >= 40 grams per day for females on average in the past year
• Liver stiffness of 10.0-18.5 kPa by VCTE, inclusive

Key exclusion criteria

• Presence of clinically significant alcohol withdrawal symptoms, defined as CIWA-Ar score >= 10 at screening and/or prior to randomization
• History of hospitalization for alcohol intoxication or alcohol withdrawal within the past year
• History of seizures related to alcohol within the past year
• History and/or current DSM-5 diagnosis of schizophrenia, bipolar disorder, psychotic disorder, or another severe psychiatric disorder, unless documented as well-controlled by the Investigator for at least 6 months prior to screening and cleared by the Medical Monitor

Where this study is enrolling

This trial has 42 US sites across 17 states. Contact the site coordinator directly to start the screening process.

Timeline

Started enrolling: 2025-06-16. Expected completion: 2027-08-31. Last updated on ClinicalTrials.gov: 2026-03-20.

Official source

We sync this data quarterly from ClinicalTrials.gov, the federal registry for clinical research. Before contacting a site, verify the trial is still recruiting on the official page:

View on ClinicalTrials.gov →

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