RECLAIM STUDY: A Phase 2 Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With Obesity or Overweight

Inclusion Criteria:

1. Written informed consent signed prior to performance of any study procedures

2. Male or female ages 18 to 75 years, inclusive

3. Diagnosis of current AUD of moderate or greater severity according to DSM-5 criteria

4. Reported drinking at least 28 drinks per week if male or 21 drinks per week iffemale in the 28 days prior to signing the informed consent. This should include atleast 3 heavy drinking days per week (defined as ≥ 5 drinks per day for men and ≥ 4drinks per day for women) Note: Baseline heavy drinking days will be determined bythe TFLB method (28-day recall) drinking pattern collected at the initial screeningvisit

5. Overweight or obesity, defined as BMI ≥ 25 kg/m2

Exclusion Criteria:

1. Presence of clinically significant alcohol withdrawal symptoms, as defined asCIWA-Ar score ≥ 10 at screening and/or prior to randomization

2. History of hospitalization for alcohol intoxication or alcohol withdrawal

3. History of alcohol-related disorders including seizures related to alcohol,MalloryWeiss Syndrome, and alcoholic ketoacidosis

4. History and/or current DSM-5 diagnosis of schizophrenia, bipolar disorder, psychoticdisorder or other severe psychiatric disorders, unless documented as well-controlledby the Investigator and cleared by the Medical Monitor

5. C-SSRS score indicative of active suicidal thoughts (answering "yes" to any ofQuestions 2 through 5 on the C-SSRS) in the past 6 months