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Pemvidutide treatment for alcohol-associated liver disease

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)

Phase 2 Interventional Altimmune, Inc. · NCT07009860

This trial will test whether a once-weekly pemvidutide injection helps improve liver health in overweight adults with alcohol-associated liver disease.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorAltimmune, Inc. Industry-sponsored
Locations43 sites (Peoria, Arizona and 42 other locations)
Trial IDNCT07009860 on ClinicalTrials.gov

What this trial studies

This Phase 2, multicenter, randomized, double-blind, placebo-controlled trial compares pemvidutide 2.4 mg subcutaneously once weekly to placebo in adults with alcohol-associated liver disease. Eligible participants are 18–75 years old, have BMI ≥25 kg/m2, a history of heavy alcohol use over the prior three years, and liver stiffness 10.0–18.5 kPa by VCTE. Key exclusions include significant alcohol withdrawal symptoms, recent hospitalization for alcohol intoxication or withdrawal, recent alcohol-related seizures, and uncontrolled severe psychiatric disorders. The study collects efficacy and safety data to determine whether pemvidutide improves liver-related measures compared to placebo.

Who should consider this trial

Good fit: Adults 18–75 who are overweight or obese, have a history of heavy alcohol use, and show liver stiffness of 10.0–18.5 kPa are the intended participants.

Not a fit: Patients with significant alcohol withdrawal, recent alcohol-related hospitalization or seizures, uncontrolled severe psychiatric disorders, or those outside the specified BMI or liver stiffness ranges are unlikely to benefit or qualify.

Why it matters

Potential benefit: If successful, pemvidutide could reduce liver stiffness and slow progression of alcohol-associated liver damage.

How similar studies have performed: Some metabolic peptide therapies have shown benefit in nonalcoholic fatty liver disease, but using pemvidutide for alcohol-associated liver disease is a novel approach that has not yet been proven.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Peoria, Arizona and 42 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alcohol Liver Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.