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

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

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

Conditions2

Interventions1

Locations42 sites

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