Does Semaglutide Reduce Alcohol Intake in Patients With Alcohol Use Disorder and Comorbid Obesity?

Summary

This 26-week long, double-blinded randomized clinical trial aims to investigate the effects of the GLP-1 receptor agonist semaglutide s.c. vs placebo on alcohol consumption in 108 patients diagnosed with alcohol use disorder and comorbid obesity (BMI\>30 kg/m2). Patients will be treated for 26 weeks with semaglutide subcutaneously (s.c.) once weekly or placebo. The medication will be provided as a supplement to standardised cognitive behavioural therapy. A subgroup of the patients will have two brain scans (Magnetic Resonance Spectroscopy (MRS) and functional Magnetic Resonance Imaging (fMRI)) conducted in one scan session at week 0 and 26. The primary endpoint is the percentage-point reduction in total number of heavy drinking days, defined as days with an excess intake of 48/60 grams of alcohol per day (women and men, respectively) from baseline to follow-up after 26 weeks of treatment, measured by the timeline followback (TLFB) method.

Timeline

Start

2023-06-13

Primary completion

2025-07-31

Completion

2025-07-31

Publications

• Klausen MK, Justesen SK, Pedersen JN, Rasmussen L, Jensen A, Jensen ME, Knorr UB, Bergmann ML, Holst JJ, Hartmann B, Koob GF, Benveniste H, Volkow ND, Ekstrom CT, Knudsen GM, Vilsboll T, Fink-Jensen A. Once-weekly semaglutide versus placebo in patients with alcohol use disorder and comorbid obesity: a randomised, double-blind, placebo-controlled trial. Lancet. 2026 May 2;407(10540):1687-1698. doi: 10.1016/S0140-6736(26)00305-3.
• Jensen ME, Klausen MK, Bergmann ML, Knudsen GM, Vilsboll T, Stove C, Fink-Jensen A. Blood phosphatidylethanol measurements indicate GLP-1 receptor stimulation causes delayed decreases in alcohol consumption. Alcohol Clin Exp Res (Hoboken). 2025 May;49(5):1161-1165. doi: 10.1111/acer.70041. Epub 2025 Mar 23.
• Klausen MK, Kuzey T, Pedersen JN, Justesen SK, Rasmussen L, Knorr UB, Mason G, Ekstrom CT, Holst JJ, Koob G, Benveniste H, Volkow ND, Knudsen GM, Vilsboll T, Fink-Jensen A. Does semaglutide reduce alcohol intake in Danish patients with alcohol use disorder and comorbid obesity? Trial protocol of a randomised, double-blinded, placebo-controlled clinical trial (the SEMALCO trial). BMJ Open. 2025 Jan 8;15(1):e086454. doi: 10.1136/bmjopen-2024-086454.

Drugs

Indications