NCT05895643

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

Does the Glucagon-like Peptide 1 (GLP-1) Receptor Agonist Semaglutide Reduce Alcohol Intake in Patients With Alcohol Use Disorder and Comorbid Obesity?

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Psychiatric Centre Rigshospitalet · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcohol Abuse
• Alcohol Addiction
• Alcohol Dependence
• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Semaglutide Injectable Product	Once weekly injections s.c with semaglutide (Wegovy)
DRUG	Placebo	Once weekly injections s.c with placebo (BD Posiflush)

Timeline

• Start date: 2023-06-13
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2023-06-08
• Last updated: 2025-08-05

Locations

1 site across 1 country: Denmark