Recruiting

Pemvidutide for Alcohol-Associated Liver Disease

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Pemvidutide

+ Placebo

DrugOther
Who is being recruted

From 18 to 75 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: June 2025
See protocol details

Summary

Principal SponsorAltimmune, Inc.
Study ContactYadira Ulrey, MD
Last updated: March 21, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 16, 2025

Actual date on which the first participant was enrolled.

This study is conducted to explore the effectiveness and safety of a drug called pemvidutide in treating people with alcohol-associated liver disease (ALD). ALD is a condition where the liver is damaged due to excessive alcohol consumption, and finding effective treatments is crucial for improving the health and lives of those affected. Participants in this study include individuals diagnosed with ALD, and the results could potentially offer a new treatment option for managing this disease. Participants in this trial receive an injection of either pemvidutide or a placebo (an inactive substance) once a week. The study is designed to ensure that neither the participants nor the researchers know who receives the actual medication or the placebo, a method called double-blind, to prevent bias. The main goal is to assess how well pemvidutide works in treating ALD and to ensure it is safe for use. By comparing the results from both groups, researchers aim to determine the efficacy and safety of the treatment.

Official TitleRESTORE 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)
NCT07009860
Principal SponsorAltimmune, Inc.
Study ContactYadira Ulrey, MD
Last updated: March 21, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Male or female ages 18 to 75 years, inclusive

Liver stiffness of 10.0-18.5 kPa by VCTE, inclusive

Overweight or obesity, defined as BMI >= 25 kg/m2

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 exclusion criteria prevent from participating
History of hospitalization for alcohol intoxication or alcohol withdrawal within the past year

History of seizures related to alcohol within the past year

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

Presence of clinically significant alcohol withdrawal symptoms, defined as CIWA-Ar score >= 10 at screening and/or prior to randomization

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 43 locations

Recruiting

Altimmune Clinical Study Site

North Little Rock, United StatesOpen Altimmune Clinical Study Site in Google Maps
Recruiting

Altimmune Clinical Study Site

Doral, United States
Recruiting

Altimmune Clinical Study Site

Miami, United States
Recruiting

Altimmune Clinical Study Site

St Louis, United States
Recruiting
43 Study Centers