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

Phase 2

Recruiting

• Conditions: Alcohol Liver Disease
• Interventions: Drug: Pemvidutide; Other: Placebo

• Registration Number: NCT07009860
• Lead Sponsor: Altimmune, Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-05
• Study First Posted: 2025-06-08
• Study Start: 2025-06-16
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-09
• Primary Completion: 2027-03-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Male or female ages 18 to 75 years, inclusive
2. Overweight or obesity, defined as BMI ≥ 25 kg/m2
3. 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
4. Liver stiffness of 10.0-18.5 kPa by VCTE, inclusive

Exclusion Criteria

1. Presence of clinically significant alcohol withdrawal symptoms, defined as CIWA-Ar score ≥ 10 at screening and/or prior to randomization
2. History of hospitalization for alcohol intoxication or alcohol withdrawal within the past year
3. History of seizures related to alcohol within the past year
4. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pemvidutide 2.4 mg	Pemvidutide	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Relative (%) change in liver stiffness by VCTE compared to baseline at Week 24	Week 24

Secondary Outcome Measures

Name	Time	Method
Relative (%) change in liver stiffness by VCTE compared to baseline at Week 48	Week 24 and 48
Absolute change in the Enhanced Liver Fibrosis (ELF) score at Weeks 24 and 48 compared to baseline	Week 24 and 48

Trial Locations

Locations (1)

Altimmune Clinical Study Site; 🇵🇷 San Juan, Puerto Rico