[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558074":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":42,"responsibleParty":57,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":83,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Insel Gruppe AG, University Hospital Bern","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Semaglutide Arm","EXPERIMENTAL","Patients assigned to this arm will be treated with semaglutide and standard of care for weight reduction (nutritional and exercise recommendations) for 16 weeks.",[13,14],"Drug: Semaglutide","Behavioral: Weight reduction recommendations (nutritional and exercise)",{"label":16,"type":17,"description":18,"interventionNames":19},"Control Arm","ACTIVE_COMPARATOR","Patients assigned to this arm will be treated with standard of care for weight reduction (nutritional and exercise recommendations) for 16 weeks.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Semaglutide","Treatment with semaglutide, following standard clinical practice as per below schedule:\n\nWeek 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.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"BEHAVIORAL","Weight reduction recommendations (nutritional and exercise)","Participants will receive nutritional and exercise recommendations and 2 telephone consultations",[16,9],[33],{"name":34,"affiliation":35,"role":36},"Susana Gomes Rodrigues, MD","University Hospital Bern (Inselspital), Hepatology","PRINCIPAL_INVESTIGATOR",[38],{"name":34,"role":39,"phone":40,"phoneExt":26,"email":41},"CONTACT","+41 31 632 59 54","susana.gomesrodrigues@insel.ch",[43],{"facility":44,"status":26,"city":45,"state":26,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"University Hospital Bern","Bern","3010","Switzerland","CH",{"type":50,"coordinates":51},"Point",[52,53],7.44744,46.94809,{"lat":53,"lon":52},[56],{"name":34,"role":39,"phone":40,"phoneExt":26,"email":41},{"type":58,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100558074","glp-1-ra-on-alcohol-consumption-metabolism-and-liver-parameters-in-patients-with-obesity-and-fatty-liver-disease-100558074",false,"NCT06546384","GLP-1 RA on Alcohol Consumption, Metabolism and Liver Parameters in Patients With Obesity and Fatty Liver Disease","Effect of Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) on Alcohol Consumption, Metabolism and Liver Parameters in Patients With Obesity and Fatty Liver Disease","GLP-1 RA","Inclusion Criteria:\n\n* BMI ≥ 35 kg\u002Fm² OR BMI ≥ 28 kg\u002Fm² in the case of weight-related co-morbidities (pre-diabetes or type 2 diabetes mellitus, hypertension, dyslipidemia).\n* Fatty liver disease (steatosis on ultrasound and\u002For CAP value on FS \\> 238 dB\u002Fm)\n* Age 18 - 80 years\n* 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)\n* Sufficient skills for German or French language (written and spoken)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Active illicit substance use\n* AUDIT-score \\\u003C 5 (males)\u002F 4 (females) (as measured from AUDIT-questionnaire distributed in visit 1)\n* Current treatment with drugs against alcohol dependence (disulfiram, acamprosate, naltrexone, baclofen and nalmefene)\n* Any known contraindication to semaglutide\n* Presence or history of a hepatic or extrahepatic malignancy from the previous 6 months","ALL","18 Years","80 Years",{"count":71,"type":72},64,"ESTIMATED","INTERVENTIONAL",[75],"NA","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.\n\nIn 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.",[78,79,80],"Adiposity","Fatty Liver","Alcohol Use Disorder",[82,23],"GLP-1","NOT_YET_RECRUITING","2026-02-23",{"date":86,"type":87},"2026-02-25","ACTUAL",{"date":89,"type":72},"2026-05-01",{"date":91,"type":72},"2027-04-30",{"name":5,"class":6},1]