A Phase 2 interventional study of Semaglutide 3 MG [Rybelsus] and Semaglutide 7 MG [Rybelsus] in Alcohol Use Disorder, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by University of Colorado, Denver · Phase 2, Interventional, and Treatment
This study is a randomized controlled trial of oral semaglutide among treatment-seeking individuals with AUD. The investigators will randomly assign 50 participants to receive semaglutide (titrated to 7 milligrams (mg) per day) or matched placebo for 8 weeks. The primary aims are to assess the safety and tolerability of semaglutide in this population and to evaluate its effects, relative to placebo, on alcohol cue-elicited craving and alcohol consumption.
A screening visit will be conducted at which written informed consent will be obtained and inclusion/exclusion criteria will be assessed. Subsequently, eligible participants will be randomly assigned to take oral semaglutide or matched placebo for 8 weeks, with the semaglutide dose titrated from 3 milligrams (mg)/day for the first 4 weeks to 7 milligrams (mg)/day for the second 4 weeks. Participants will complete 7 additional clinic visits (weekly during the first 4 weeks of the treatment period and biweekly during the second 4 weeks). At each visit, participants will also engage in a computerized behavioral intervention. At screening and again at the Week 6 visit, participants will complete an alcohol cue reactivity task. At the Week 1 visit, before ingesting the first dose of study medication, and again at the Week 8 visit, participants will complete a functional MRI session.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 50 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
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Please contact clinical site for additional inclusion criteria.
Exclusion Criteria:
Participants in this Arm will take a medically inert placebo. To ensure pill equivalence between groups, tablets will be packaged in the same capsule; thus, each participant will take one capsule per day. Participants will be instructed to ingest the capsule orally each morning.
Drug: Placebo
Participants in this Arm will study medication for a total of 8 weeks - on semaglutide 3 milligrams per day for 4 weeks, then 7 milligrams per day for 4 weeks. To ensure pill equivalence between groups, tablets will be packaged in the same capsule; thus, each participant will take one capsule per day. Participants will be instructed to ingest the capsule orally each morning.
Drug: Semaglutide 3 MG [Rybelsus] · Drug: Semaglutide 7 MG [Rybelsus]
Semaglutide 3 mg will be taken for the first 4 weeks of the 8-week trial.
Also known as: Rybelsus 3 mg
Semaglutide 7 mg will be taken for the second 4 weeks of the 8-week trial.
Also known as: Rybelsus 7 mg
A medically inert placebo medication will be taken for 8 weeks.
Change in Cue Craving Visual Analog Score
The primary efficacy endpoint will be the magnitude of change between screening and Week 6 in the cue-craving VAS score on the first VAS item ("How strong is your craving to drink alcohol?") administered after the alcohol cue presentation. Scores range from 0 (none) to 20 (extremely strong). Higher scores indicate a higher level of craving.
Time frame: 7 weeks - change between screening and Week 6 visit
Number of drinks per day
The number of standard alcoholic drinks participants consume per day during the last 4 weeks of the treatment period (Week 5-8), as reported on the Timeline Follow-Back Interview.
Time frame: 4 weeks
Percentage of heavy drinking days
The percentage of heavy drinking days during the last 4 weeks of the treatment period (Week 5-8), as reported on the Timeline Follow-Back Interview.
Time frame: 4 weeks
Change in alcohol cue-elicited brain activation
Change in fMRI BOLD activation to alcohol vs. neutral beverage visual cues between baseline and Week 8.
Time frame: 8 weeks
Plan to share: Yes — De-identified, individual-level phenotypic data will be submitted to the NIAAA Data Archive (NDA) portal once it is available. Informed consent that allows for broad sharing of each subject\'s de-identified data will be obtained and personally identifiable information that allows the creation of an NDA Global Unique Identifier will be collected. The PI and study staff will work with NDA staff to specify and/or define measures to be collected, and data will be submitted in accordance with NDA submission due dates.
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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver