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

Plain-language guide to NCT07009860: phase 2 randomized trial of Pemvidutide, 121 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT07009860
Phase: phase 2
Status: active, not recruiting
Start: 2025-06-16
Completion (planned or actual): 2027-09-30
Participants: 121 (actual)
Design: randomized, quadruple-blind, treatment
Conditions studied: Alcohol-associated Liver Disease
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 2 trial tested Pemvidutide.

It had two arms (groups): one (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 121 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female ages 18 to 75 years, inclusive. Overweight or obesity, defined as BMI ≥ 25 kg/m2. Evidence of recent alcohol use, defined as PEth level ≥ 35 ng/mL at screening. Liver stiffness of 10.0-24.9 kPa by VCTE, inclusive.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: history of hospitalization for alcohol withdrawal within the past year; history of seizures related to alcohol within the past year; attempted suicide and/or serious suicidal intention or plan in the past 10 years.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Pemvidutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Pemvidutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2025-06-16 with completion listed for 2027-09-30.

It ran at 37 sites in United States (36) and Puerto Rico (1).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Pemvidutide in 121 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Pemvidutide compound page, all human trials.

Our Notes on the Compound

Pemvidutide: An investigational once-weekly GLP-1/glucagon dual agonist studied for obesity and fatty liver disease (MASH).

Pemvidutide in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.