RecruitingAlcohol Liver Disease

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

Eligible age

18–75 yrs

Accepts

All genders

Locations

17 states

Healthy volunteers

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About this study

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

Sponsor: Altimmune, Inc.

You may qualify if…

✓ 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

You may not qualify if…

✕ 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