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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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.

Eligibility criteria

Qualifiers

BMI ≥ 35 kg/m² OR BMI ≥ 28 kg/m² in the case of weight-related co-morbidities (pre-diabetes or type 2 diabetes mellitus, hypertension, dyslipidemia).

Fatty liver disease (steatosis on ultrasound and/or CAP value on FS > 238 dB/m)

Age 18 - 80 years

Alcohol Use Disorder Identification Test-C Score >4 (AUDIT-C) Score ≥4 for women and ≥5 for men (as measured from AUDIT-questionnaire distributed in visit 1)

Disqualifiers

Active illicit substance use

AUDIT-score < 5 (males)/ 4 (females) (as measured from AUDIT-questionnaire distributed in visit 1)

Current treatment with drugs against alcohol dependence (disulfiram, acamprosate, naltrexone, baclofen and nalmefene)

Any known contraindication to semaglutide

Trial design

Treatments tested in this trial

  • Semaglutide
  • Weight reduction recommendations (nutritional and exercise)

Treatment groups

64 Participants
are divided into 2 treatment groups