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

Launched by ALTIMMUNE, INC. · May 16, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called pemvidutide to see if it can help people who have Alcohol Use Disorder (AUD) and are also overweight or obese. The trial is designed to find out how effective and safe pemvidutide is compared to a placebo (a harmless substance with no active ingredients). Participants will be randomly assigned to receive either pemvidutide or the placebo once a week for their treatment.

To be eligible for the trial, participants need to be between 18 and 75 years old and have a diagnosis of moderate to severe AUD. They should also be drinking a significant amount of alcohol regularly—at least 28 drinks per week for men or 21 drinks per week for women—and have a body mass index (BMI) of 25 or higher, which indicates being overweight or obese. Participants will first sign a consent form and go through a screening process to make sure they meet the requirements. If they join the study, they can expect to attend regular visits for monitoring and support throughout the treatment period.

Gender

ALL

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