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

Conditions

• Alcohol Liver Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Pemvidutide — DRUG
  Pemvidutide 2.4 mg
• Placebo — OTHER
  Subcutaneous 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. * Pemvidutide: 2.4 mg SC once weekly * Placebo: Placebo SC once weekly

Key Dates

Start date

Jun 16, 2025

Status verified

Mar 2026

Primary completion

Mar 31, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pemvidutide 2.4 mg
• Placebo Comparator: Placebo

Primary Outcome Measure

Relative (%) change in liver stiffness by VCTE compared to baseline at Week 24 [ Time Frame: Week 24 ]

Central Contacts

• Yadira Ulrey, MD
  619-869-1842
  [email protected]

Locations (42)

Find similar trials in Peoria, AZ

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