RecruitingPhase 2NCT07009860
RESTORE TRIAL: A Phase 2 Study Evaluating 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)
Sponsor
Altimmune, Inc.
Enrollment
100 participants
Start Date
Jun 16, 2025
Study Type
INTERVENTIONAL
Conditions
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. * Pemvidutide: 2.4 mg SC once weekly * Placebo: Placebo SC once weekly
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria4
- Male or female ages 18 to 75 years, 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
- Liver stiffness of 10.0-18.5 kPa by VCTE, inclusive
Exclusion Criteria4
- Presence of clinically significant alcohol withdrawal symptoms, defined as CIWA-Ar score ≥ 10 at screening and/or prior to randomization
- 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
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Interventions
DRUGPemvidutide
Pemvidutide 2.4 mg
OTHERPlacebo
Subcutaneous injection
Locations(43)
View Full Details on ClinicalTrials.gov
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NCT07009860