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
NCT06987513 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-11-19
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
Conditions
- Alcohol Use Disorder (AUD)
Interventions
- DRUG
-
Pemvidutide
Pemvidutide 2.4mg
- OTHER
-
Placebo
Subcutaneous injection
Sponsors & Collaborators
-
Altimmune, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-15
- Primary Completion
- 2026-05-31
- Completion
- 2026-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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