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
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
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
Parallel
Pemvidutide
DrugPemvidutide 2.4 mg
Placebo
Other interventionSubcutaneous injection
Relative (%) change in liver stiffness by VCTE compared to baseline at Week 24
Relative (%) change in liver stiffness by VCTE compared to baseline at Week 48
Absolute change in the Enhanced Liver Fibrosis (ELF) score at Weeks 24 and 48 compared to baseline
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