Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Altimmune, Inc.
Conditions:
Alcohol Use Disorder (AUD)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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. Af...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06987513
Start Date
May 15 2025
End Date
June 1 2026
Last Update
November 19 2025
Active Locations (12)
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1
Altimmune Clinical Study Site
Los Angeles, California, United States, 90038
2
Altimmune Clinical Study Site
Aurora, Colorado, United States, 80045
3
Altimmune Clinical Study Site
New Haven, Connecticut, United States, 06511
4
Altimmune Clinical Study Site
Fort Myers, Florida, United States, 33912