GLP-1 RA on Alcohol Consumption, Metabolism and Liver Parameters in Patients With Obesity and Fatty Liver Disease
NCT Number: NCT06546384
Acronym: GLP-1 RA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Adiposity|Fatty Liver|Alcohol Use Disorder
Interventions: DRUG: Liraglutide|BEHAVIORAL: Weight reduction recommendations (nutritional and exercise)
Sponsor: Insel Gruppe AG, University Hospital Bern
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-08-31
Locations: University Hospital Bern, Bern, 3010, Switzerland

Summary:
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 liraglutide can improve the liver sinusoidal milieu in pre-clinical models of cirrhosis.

In this study, the investigators aim to assess if patients treated with liraglutide and receiving counselling will achieve a significantly higher alcohol abstinence compared to patients only receiving counselling.

Primary Outcome Measures: 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 liraglutide vs control., From inclusion date (baseline) until end of the study, total duration 16 weeks per patient
Secondary Outcome Measures: 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 liraglutide vs control., From inclusion date (baseline) until end of the study, total duration 16 weeks per patient|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 liraglutide vs. control, From inclusion date (baseline) until end of the study, total duration 16 weeks per patient|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 liraglutide vs. control (measured by TFLB method), From inclusion date (baseline) until end of the study, total duration 16 weeks per patient|Change of heavy drinking days (by TFLB method), Assessment of change in percentage of heavy drinking days after treatment compared to before treatment with liraglutide vs. control (measured by TFLB method), From inclusion date (baseline) until end of the study, total duration 16 weeks per patient|Change of total number of drinks per week (by TFLB method), Assessment of change in percentage of total number of drinks per week after treatment compared to weeks before treatment with liraglutide vs. control (measured by TFLB method), From inclusion date (baseline) until end of the study, total duration 16 weeks per patient|Pre and post treatment comparison of total abstinence (PEth test), Change from baseline in number of patients with total alcohol abstinence as assessed by PEth test., From inclusion date (baseline) until end of the study, total duration 16 weeks per patient|Pre and post treatment comparison of total abstinence (assessed by TFLB method), Change from baseline in number of patients with total alcohol abstinence as assessed by TFLB method., From inclusion date (baseline) until end of the study, total duration 16 weeks per patient|Pre and post treatment comparison of total abstinence (measured by negative EtG), Change from baseline in number of patients with total alcohol abstinence measured by negative EtG., From inclusion date (baseline) until end of the study, total duration 16 weeks per patient|Pre and post treatment comparison of cumulative abstinent days (by TFLB method), Change from baseline in number of cumulative abstinent days per patient (measured by TFLB method)., From inclusion date (baseline) until end of the study, total duration 16 weeks per patient|Pre and post treatment comparison of drinking days (by TFLB method), Change from baseline in number of drinking days per patient (measured by TFLB method)., From inclusion date (baseline) until end of the study, total duration 16 weeks per patient|Pre and post treatment comparison of number of drinks per week (by TFLB method), Change from baseline in number of drinks per week per patient (measured by TFLB method)., From inclusion date (baseline) until end of the study, total duration 16 weeks per patient|Effects of liraglutide on reward and relief drinking behavior, Assessments of effects of liraglutide on reward and relief drinking behavior (assessed with the Alcohol Expectancy Questionnaire, both study arms)., From inclusion date (baseline) until end of the study, total duration 16 weeks per patient|Percentage reduction in transient liver elastography levels assessed by Fibroscan, Percentage reduction in transient liver elastography levels by vibration controlled transient elastography (Fibroscan) from baseline until after 16 weeks of therapy (both study arms)., From inclusion date (baseline) until end of the study, total duration 16 weeks per patient|Percentage reduction in transient liver elastography levels assessed by FIB-4 score, Percentage reduction in transient liver elastography levels by FIB-4 score (fibrosis assessment including age, AST, ALT and platelet count) from baseline until after 16 weeks of therapy (both study arms)., From inclusion date (baseline) until end of the study, total duration 16 weeks per patient|Percentage reduction in metabolic markers, Percentage reduction in metabolic markers (both study arms): body weight, BMI, fasting glucose, homeostatic model assessment of insulin resistance (HOMA-IR), HbA1c levels from baseline until 16 weeks after therapy, From inclusion date (baseline) until end of the study, total duration 16 weeks per patient|Safety profile of liraglutide in described population, Number and description of SAE's concerning liraglutide in described population (liraglutide arm only)., From inclusion date (baseline) until end of the study, total duration 16 weeks per patient|Effect of GLP-1 RA therapy on TMA/TMAO pathway, Statistically significant % reduction of TMAO levels (measured by blood test at baseline and after 16 weeks of therapy, liraglutide arm only)., From inclusion date (baseline) until end of the study, total duration 16 weeks per patient