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.
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)
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
Parallel
Semaglutide
DrugTreatment 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)
BehavioralParticipants will receive nutritional and exercise recommendations and 2 telephone consultations
Proportion of patients achieving total alcohol abstinence (measured by negative PEth test)
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.
Proportion of patients achieving total alcohol abstinence (measured by TFLB method)
Percentage of patients achieving total alcohol abstinence from baseline to follow-up after 16 weeks of treatment, measured by TFLB method, in patients treated with semaglutide vs control.
Proportion of patients maintaining total alcohol abstinence (measured by negative EtG)
Percentage of patients maintaining total alcohol abstinence from baseline to follow-up after 16 weeks of treatment, measured by negative EtG in patients treated semaglutide vs. control
Change of alcohol abstinent days (cumulative abstinent days, by TFLB method)
Assessment of change in percentage of alcohol abstinent days after treatment compared to before treatment with semaglutide vs. control (measured by TFLB method)
Change of heavy drinking days (by TFLB method)
Assessment of change in percentage of heavy drinking days after treatment compared to before treatment with semaglutide vs. control (measured by TFLB method)
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