Does Semaglutide Reduce Alcohol Intake in Patients With Alcohol Use Disorder and Comorbid Obesity?
Status:
Not yet recruiting
Trial end date:
2027-03-01
Target enrollment:
Participant gender:
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.