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NCT07218354 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by VA Office of Research and Development.
- Not yet
- Registry status
- Phase 3
- Development phase
- 622
- Enrollment target
NCT07218354: Clinical Trial Phase 3 study, sponsored by VA Office of Research and Development.
NCT07218354 is a Phase 3 study that has not yet begun recruiting, run by VA Office of Research and Development. The registered enrollment target is 622 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07218354, a Phase 3 study, has not yet begun recruiting, sponsored by VA Office of Research and Development.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 622 participants
- Enrollment target
Study Summary
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 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.
Primary Outcome
Number of participants with at least a two-level reduction, from baseline risk level, in WHO risk drinking level. The WHO risk drinking levels categorize alcohol consumption into four groups: low (level 1; 0-2.86 standard drinks/day for men; 0-1.43 drinks/day for women), moderate (level 2; 2.87-4.29 standard drinks/day for men; 1.44-2.86 drinks/day for women), high (level 3; 4.3-7.14 standard drinks/day for men; 2.87-4.29 drinks/day for women), and very high (level 4; \>7.15 drinks/day for men;
Interventions
- DRUG Placebo
- DRUG Semaglutide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 622 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2029-05-26 |
| Phase | Phase 3 |
What is known before NCT07218354 opens enrollment
NCT07218354 is an interventional study that assigns participants to a tested intervention. The registered 622 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07218354 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07218354 about?
NCT07218354 is a clinical study titled "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". 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-w...
What is the current status of trial NCT07218354?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 622 participants. The study started on 2026-07-01. Estimated completion is 2029-05-26.
What interventions are being tested in trial NCT07218354?
The interventions under investigation include: Placebo (DRUG), Semaglutide (DRUG).
Who is sponsoring clinical trial NCT07218354?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07218354's enrollment target sits among peer trials
622 588th of 2000 higher than 1,413 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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