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

Launched by ALTIMMUNE, INC. · Jun 5, 2025

Keywords

ClinConnect Summary

The RESTORE TRIAL is a clinical study designed to evaluate a new treatment called pemvidutide for people with Alcohol-Associated Liver Disease (ALD). This is a Phase 2 trial, meaning it's looking at how effective and safe pemvidutide is compared to a placebo (a substance with no active treatment) in helping patients with this condition. The trial will involve participants receiving either pemvidutide or a placebo through an injection under the skin once a week. It aims to include adults aged 18 to 75 who have been dealing with alcohol misuse and have certain levels of liver stiffness, which is measured by a non-invasive test.

To be eligible for the study, participants should be overweight or have obesity, with a body mass index (BMI) of 25 or higher, and have a history of drinking above set limits for at least the past year. It's important to note that those with serious alcohol withdrawal symptoms or certain psychiatric conditions may not be able to participate. While the trial is not yet recruiting participants, those who join can expect to contribute to research that could lead to better treatments for liver disease caused by alcohol use.

Gender

ALL

Eligibility criteria

• 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