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

Sponsor
Psychiatric Centre Rigshospitalet
Study ID
NCT05895643
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide Injectable Product — DRUG
    Once weekly injections s.c with semaglutide (Wegovy)
  • Placebo — DRUG
    Once weekly injections s.c with placebo (BD Posiflush)

Study Details

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.

Key Dates

Start date
Jun 13, 2023
Status verified
Aug 2025
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
108 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: semaglutide
    Wegovy once-weekly s.c.titrated to a maximum dose of 2.4 mg
  • Placebo Comparator: placebo
    Saline s.c. once-weekly

Primary Outcome Measure

Change in heavy drinking days [ Time Frame: From baseline to 26 weeks of treatment ]

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