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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alcohol Use Disorder (AUD)

In brief

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

Key facts

Study ID

NCT06987513

Run by

Altimmune, Inc.

People needed

100

Starts

2025-05-15

Expected to finish

2026-07-30

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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