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

About

Brief Summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in the treatment of AUD in subjects with obesity or overweight. After signing the informed consent form, subjects will be screened and if eligible randomized 1:1 to 1 of the following 2 treatment arms:

Pemvidutide: 2.4 mg SC once weekly
Placebo: Placebo SC once weekly

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

75 Years

Inclusion Criteria:

Written informed consent signed prior to performance of any study procedures
Male or female ages 18 to 75 years, inclusive
Diagnosis of current AUD of moderate or greater severity according to DSM-5 criteria
Reported drinking at least 28 drinks per week if male or 21 drinks per week if female in the 28 days prior to signing the informed consent. This should include at least 3 heavy drinking days per week (defined as ≥ 5 drinks per day for men and ≥ 4 drinks per day for women) Note: Baseline heavy drinking days will be determined by the TFLB method (28-day recall) drinking pattern collected at the initial screening visit
Overweight or obesity, defined as BMI ≥ 25 kg/m2

Exclusion Criteria:

Presence of clinically significant alcohol withdrawal symptoms, as defined as CIWA-Ar score ≥ 10 at screening and/or prior to randomization
History of hospitalization for alcohol intoxication or alcohol withdrawal
History of alcohol-related disorders including seizures related to alcohol, MalloryWeiss Syndrome, and alcoholic ketoacidosis
History and/or current DSM-5 diagnosis of schizophrenia, bipolar disorder, psychotic disorder or other severe psychiatric disorders, unless documented as well-controlled by the Investigator and cleared by the Medical Monitor
C-SSRS score indicative of active suicidal thoughts (answering "yes" to any of Questions 2 through 5 on the C-SSRS) in the past 6 months

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