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RESTORE TRIAL: A Phase 2 Stud...

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

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-16

Study Completion Date

2027-08-31

Brief Summary

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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

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Detailed Description

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Conditions

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Alcohol Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pemvidutide 2.4 mg

Group Type EXPERIMENTAL

Pemvidutide

Intervention Type DRUG

Pemvidutide 2.4 mg

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Subcutaneous injection

Interventions

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Pemvidutide

Pemvidutide 2.4 mg

Intervention Type DRUG

Placebo

Subcutaneous injection

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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