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

RESTORE TRIAL: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07009860

Enrollment

121

Registered

2025-06-08

Start date

2025-06-16

Completion date

2027-09-30

Last updated

2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol-associated Liver Disease

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.

Interventions

DRUGPemvidutide

Pemvidutide 2.4 mg SC Injection

OTHERPlacebo

Placebo SC Injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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. Evidence of recent alcohol use, defined as PEth level ≥ 35 ng/mL at screening 5. Liver stiffness of 10.0-24.9 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 withdrawal within the past year 3. History of seizures related to alcohol within the past year 4. History and/or current 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 5. Attempted suicide and/or serious suicidal intention or plan in the past 10 years

Design outcomes

Primary

Measure	Time frame
Relative (%) reduction in liver stiffness by VCTE compared to baseline	Week 48 and 24

Secondary

Measure	Time frame
Absolute reduction in liver stiffness by vibration controlled transient elastography (VCTE)	Week 48 and 24
Absolute reduction in the Enhanced Liver Fibrosis (ELF) compared to baseline	Week 48 and 24

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 18, 2026