NCT05892432

Clinical Trial of Rybelsus (Semaglutide) Among Adults With Alcohol Use Disorder (AUD)

Completed Phase 2 Last updated 26 December 2025

What this trial tests

Phase 2 trial testing Semaglutide 3 MG [Rybelsus] in Alcohol Use Disorder in 50 participants. Completed in 15 November 2025.

Timeline

11 January 2024

Primary endpoint
4 November 2025

15 November 2025

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	quadruple
Primary purpose	treatment
Enrollment	50
Start date	11 January 2024
Primary completion	4 November 2025
Estimated completion	15 November 2025
Sites	1 location across United States

Drugs / interventions tested

• Semaglutide 3 MG [Rybelsus] — full drug profile →
• Semaglutide 7 MG [Rybelsus] — full drug profile →
• Placebo

Conditions studied

• Alcohol Use Disorder — all drugs for Alcohol Use Disorder →

Sponsor

University of Colorado, Denver

Who can join

21 and older, any sex, with Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide on alcohol consumption in alcohol-preferring male vervet monkeys.
   Fink-Jensen A, Wörtwein G, Klausen MK, Holst JJ, et al · · 2025 · cited 36× · PMID 38884652 · DOI 10.1007/s00213-024-06637-2
2. Association between glucagon-like peptide-1 receptor agonists use and change in alcohol consumption: a systematic review.
   Subhani M, Dhanda A, King JA, Warren FC, et al · · 2024 · cited 27× · PMID 39764544 · DOI 10.1016/j.eclinm.2024.102920
3. Glucagon-like peptide-1 receptor agonists, but not dipeptidyl peptidase-4 inhibitors, reduce alcohol intake.
   Farokhnia M, Tazare J, Pince CL, Bruns N, et al · · 2025 · cited 26× · PMID 40048376 · DOI 10.1172/jci188314
4. Ecological momentary assessment and cue-elicited drug craving as primary endpoints: study protocol for a randomized, double-blind, placebo-controlled clinical trial testing the efficacy of a GLP-1 receptor agonist in opioid use disorder.
   Freet CS, Evans B, Brick TR, Deneke E, et al · · 2024 · cited 10× · PMID 39061093 · DOI 10.1186/s13722-024-00481-7
5. Semaglutide as a GLP-1 Agonist: A Breakthrough in Obesity Treatment.
   Salvador R, Moutinho CG, Sousa C, Vinha AF, et al · · 2025 · cited 9× · PMID 40143174 · DOI 10.3390/ph18030399
6. Effects of GLP-1 Receptor Agonists in Alcohol Use Disorder.
   Klausen MK, Knudsen GM, Vilsbøll T, Fink-Jensen A. · · 2025 · cited 8× · PMID 39891507 · DOI 10.1111/bcpt.70004
7. Closing the Care Gap: Management of Alcohol Use Disorder in Patients with Alcohol-associated Liver Disease.
   Green EW, Byers IS, Deutsch-Link S. · · 2023 · cited 8× · PMID 38052695 · DOI 10.1016/j.clinthera.2023.09.017
8. GLP-1 Therapeutics and Their Emerging Role in Alcohol and Substance Use Disorders: An Endocrinology Primer.
   Srinivasan NM, Farokhnia M, Farinelli LA, Ferrulli A, et al · · 2025 · cited 7× · PMID 41081017 · DOI 10.1210/jendso/bvaf141