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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Alcohol Liver Disease

In brief

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in subjects with ALD. * Pemvidutide: 2.4 mg SC once weekly * Placebo: Placebo SC once weekly

Key facts

Study ID

NCT07009860

Run by

Altimmune, Inc.

People needed

100

Starts

2025-06-16

Expected to finish

2027-08-31

Last updated by the study team

2026-03-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Altimmune Clinical Study Site — Syracuse, New York, United States (enrolling)
• Altimmune Clinical Study Site — Miami, Florida, United States (enrolling)
• Altimmune Clinical Study Site — San Antonio, Texas, United States (enrolling)
• Altimmune Clinical Study Site — San Antonio, Texas, United States (enrolling)
• Altimmune Clinical Study Site — St Louis, Missouri, United States (enrolling)
• Altimmune Clinical Study Site — Doral, Florida, United States (enrolling)
• Altimmune Clinical Study Site — North Little Rock, Arkansas, United States (enrolling)
• Altimmune Clinical Study Site — New York, New York, United States (enrolling)
• Altimmune Clinical Study Site — Doral, Florida, United States
• Altimmune Clinical Study Site — Fort Myers, Florida, United States
• Altimmune Clinical Study Site — Miami, Florida, United States
• Altimmune Clinical Study Site — Miami Lakes, Florida, United States
• Altimmune Clinical Study Site — Naples, Florida, United States
• Altimmune Clinical Study Site — Orlando, Florida, United States
• Altimmune Clinical Study Site — Port Orange, Florida, United States
• Altimmune Clinical Study Site — Atlanta, Georgia, United States
• Altimmune Clinical Study Site — Indianapolis, Indiana, United States
• Altimmune Clinical Study Site — Louisville, Kentucky, United States
• Altimmune Clinical Study Site — Bastrop, Louisiana, United States
• Altimmune Clinical Study Site — Marrero, Louisiana, United States
• Altimmune Clinical Study Site — West Monroe, Louisiana, United States
• Altimmune Clinical Study Site — Kansas City, Missouri, United States
• Altimmune Clinical Study Site — Las Vegas, Nevada, United States
• Altimmune Clinical Study Site — Manhasset, New York, United States
• Altimmune Clinical Study Site — Wilmington, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.