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

NCT06987513

CompletedPhase 2

Sponsor: Altimmune, Inc.

Conditions: Alcohol Use Disorder (AUD)

Interventions: Pemvidutide, Placebo

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Exclusion Criteria:

1. Presence of clinically significant alcohol withdrawal symptoms, as defined as CIWA-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, psychotic disorder or other severe psychiatric disorders, unless documented as well-controlled by the Investigator and cleared by the Medical Monitor
5. 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

Locations (12)

Los Angeles, California, United States
Aurora, Colorado, United States
New Haven, Connecticut, United States
Fort Myers, Florida, United States
University Park, Florida, United States
North Canton, Ohio, United States
Tulsa, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Providence, Rhode Island, United States
Charleston, South Carolina, United States
Charlottesville, Virginia, United States
Richmond, Virginia, United States