Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of a GLP-1 Receptor Agonist Semaglutide in U.S. Veterans With Alcohol Use Disorder

Conditions

• Alcohol Use Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Accepted

Interventions

• Semaglutide — DRUG
  Weekly subcutaneous injections of semaglutide up to 2.4 mg/week or maximum tolerated dose. Initial dosing starting at 0.25 for weeks 1-4. Further titration up to 2.4 mg weekly starting at week 5.
• Placebo — DRUG
  Weekly subcutaneous injections of placebo.

Study Details

This clinical trial aims to test the effectiveness and safety of semaglutide, a GLP-1 receptor agonist, in treating moderate to severe alcohol use disorder (AUD) in Veterans. Participants who qualify will be randomly assigned to receive either semaglutide injections or placebo injections over a 28-week period, followed by a 4-week post-treatment safety assessment period. Participants receiving semaglutide will start with a low dose, gradually increasing to a maximum of 2.4 milligrams (mg) per week, depending on their tolerance. The primary measure of success will be a reduction in risky drinking, assessed through a reliable calendar-based interview method called the Timeline Follow-Back (TLFB), a well-validated calendar-based interview technique for recording daily alcohol consumption. The purpose of this research is to gather information on the effectiveness of semaglutide for treating AUD, potentially offering a new and more appealing treatment option.

Key Dates

First listed

Oct 20, 2025

Start date

Jul 28, 2026

Status verified

Jul 2026

Primary completion

Mar 31, 2029

Completion

Mar 30, 2030

Study Design

Enrollment

622 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Semaglutide
  Weekly subcutaneous injections of semaglutide up to 2.4 mg/week or maximum tolerated dose. Initial dosing starting at 0.25 for weeks 1-4. Further titration up to 2.4 mg weekly starting at week 5.
• Placebo Comparator: Placebo
  Weekly subcutaneous injections of placebo.

Primary Outcome Measure

Two-level reduction in the World Health Organization (WHO) risk drinking level assessed in the last 28 days of intervention [ Time Frame: Change from Baseline to Weeks 5-28. Includes six repeated measurements every 4 weeks from week 5 to 28. ]

Central Contacts

• David W Oslin, MD
  (215) 823-5870
  [email protected]
• Neil C Johnson, MA BA
  (702) 202-8387
  [email protected]

Locations (19)

Find similar trials in Long Beach, CA

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