NCT07009860

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

RESTORE TRIAL: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Altimmune, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Alcohol Liver Disease

Interventions

Type	Name	Description
DRUG	Pemvidutide	Pemvidutide 2.4 mg
OTHER	Placebo	Subcutaneous injection

Timeline

• Start date: 2025-06-16
• Primary completion: 2027-03-31
• Completion: 2027-08-31
• First posted: 2025-06-08
• Last updated: 2026-03-20

Locations

43 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study