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

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Aug 6, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called semaglutide can help patients with obesity and fatty liver disease reduce their alcohol consumption more effectively than just counseling alone. Researchers believe that semaglutide may support liver health and help people cut back on drinking, which can be especially important for those at risk of liver disease.

To participate in the trial, individuals need to be between 18 and 80 years old, have a body mass index (BMI) of 28 or higher, and be diagnosed with fatty liver disease. They should also have a moderate to high level of alcohol use as measured by a specific questionnaire. Participants can expect to receive counseling and treatment with semaglutide, and they will be closely monitored throughout the study to see how well the medication helps them reduce their alcohol intake. It's important to note that certain conditions, like current drug treatments for alcohol dependence or recent cancer diagnoses, may prevent someone from joining the trial.

Gender

ALL

Eligibility 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