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

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 gramsper 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-Arscore ≥ 10 at screening and/or prior to randomization

2. History of hospitalization for alcohol intoxication or alcohol withdrawal within thepast year

3. History of seizures related to alcohol within the past year

4. History and/or current DSM-5 diagnosis of schizophrenia, bipolar disorder, psychoticdisorder, or another severe psychiatric disorder, unless documented aswell-controlled by the Investigator for at least 6 months prior to screening andcleared by the Medical Monitor