Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT06546384

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 80 Years

SexAll

Healthy volunteersNot accepted

ConditionAdiposity, Fatty Liver, Alcohol Use Disorder

Full registry criteria

Inclusion Criteria: * 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) * Sufficient skills for German or French language (written and spoken) * Signed informed consent Exclusion Criteria: * 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 * Presence or history of a hepatic or extrahepatic malignancy from the previous 6 months

Treatments and study arms

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

Primary outcomes

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

Percentage of patients achieving total alcohol abstinence from baseline to follow-up after 16 weeks of treatment, measured by negative PEth test, in patients treated with semaglutide vs control.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University Hospital Bern🇨🇭 Bern, Switzerland

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Susana Gomes Rodrigues, MDContact

Email · Call +41 31 632 59 54