Actively Recruiting
Phase 2 Study of Pemvidutide to Treat Alcohol-Associated Liver Disease in Adults Aged 18 to 75
Led by Altimmune, Inc. · Updated on 2026-03-20
100
Participants Needed
43
Research Sites
21 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effectiveness of pemvidutide in adults with Alcohol-Associated Liver Disease ALD. This Phase 2 trial is randomized, double-blind, and placebo-controlled, aiming to understand how pemvidutide affects liver stiffness in people who have a history of alcohol misuse and liver damage. The study is sponsored by Altimmune, Inc. and includes participants aged 18 to 75 years with overweight or obesity and specific liver stiffness measurements. Participants will receive either 2.4 mg of pemvidutide or a placebo through a weekly subcutaneous injection. The treatment lasts for 24 weeks, with continued monitoring up to 48 weeks to assess changes over time. The study design includes separate groups receiving pemvidutide or placebo to compare outcomes such as liver stiffness and the Enhanced Liver Fibrosis ELF score. During the study, participants will have liver stiffness measured by vibration-controlled transient elastography VCTE at baseline, week 24, and week 48. They will also undergo blood tests to evaluate fibrosis changes. Researchers will track safety and monitor symptoms throughout the study. Total participation includes treatment and follow-up visits over nearly a year, with detailed assessments to understand how the treatment impacts liver health.
CONDITIONS
Brief Title
RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)
Research Team
Y
Yadira Ulrey, MD
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