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

NCT07009860 · Recruiting

Last updated 2026-05-28

This clinical trial is testing the drug pemvidutide in adults with alcohol-associated liver disease to see how it affects liver stiffness over 24 weeks.

Status Recruiting Currently enrolling participants.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 100 people Planned (estimated).

Who can join Ages 18–75 · all sexes

Timeline Started 2025-06 · est. completion 2027-08

Where 43 sites · Puerto Rico, United States

What this study is testing ClinicalTrials.gov NCT07009860 ↗

Description as written by the study sponsor.

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

Treatments tested

Pemvidutide Drug

Pemvidutide 2.4 mg
Placebo Other

Subcutaneous injection

Main thing measured	Relative (%) change in liver stiffness by VCTE compared to baseline at Week 24
Sponsor	Altimmune, Inc.
Conditions studied	Alcohol Liver Disease
GLP-1 drugs	pemvidutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07009860 ↗