GLP-1 RA on Alcohol Consumption, Metabolism and Liver Parameters in Patients With Obesity and Fatty Liver Disease

Sponsor
Insel Gruppe AG, University Hospital Bern
Study ID
NCT06546384
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — DRUG
    Treatment with semaglutide, following standard clinical practice as per below schedule: Week 1-4: Injected dose of 0,25 mg i.d. Week 5-8: Injected dose of 0,5 mg i.d. Week 9-12: Injected dose of 1,0 mg i.d. Week 13-16: Injected dose of 1,7 mg i.d. After week 16: Injected dose of 2,4 mg i.d.
  • Weight reduction recommendations (nutritional and exercise) — BEHAVIORAL
    Participants will receive nutritional and exercise recommendations and 2 telephone consultations

Study Details

There is evidence that alcoholic beverage consumption significantly interacts with food energy intake. Furthermore, there is accumulating evidence showing independent, combined, and modifying effects of alcohol and metabolic factors on the onset and progression of chronic liver disease. Preclinical and clinical data have showed that GLP-1 RA can decrease alcohol consumption, particularly in obese patients. Moreover there is evidence that semaglutide can improve the liver sinusoidal milieu in pre-clinical models of cirrhosis. In this study, the investigators aim to assess if patients treated with semaglutide and receiving counselling will achieve a significantly higher alcohol abstinence compared to patients only receiving counselling.

Key Dates

Start date
May 1, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide Arm
    Patients assigned to this arm will be treated with semaglutide and standard of care for weight reduction (nutritional and exercise recommendations) for 16 weeks.
  • Active Comparator: Control Arm
    Patients assigned to this arm will be treated with standard of care for weight reduction (nutritional and exercise recommendations) for 16 weeks.

Primary Outcome Measure

Proportion of patients achieving total alcohol abstinence (measured by negative PEth test) [ Time Frame: From inclusion date (baseline) until end of the study, total duration 16 weeks per patient ]

Central Contacts

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