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

Conditions

• Alcohol-associated Liver Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Pemvidutide — DRUG
  Pemvidutide 2.4 mg SC Injection
• Placebo — OTHER
  Placebo SC Injection

Study Details

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in subjects with ALD.

Key Dates

First listed

Jun 8, 2025

Start date

Jun 16, 2025

Status verified

Aug 2026

Primary completion

Sep 30, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

121 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Pemvidutide 2.4 mg
• Placebo Comparator: Placebo

Primary Outcome Measure

Relative (%) reduction in liver stiffness by VCTE compared to baseline [ Time Frame: Week 48 and 24 ]

Locations (36)

Find similar trials in Peoria, AZ

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