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

NCT06546384 | Not Yet Recruiting

• 1 other identifier: 2023-01715
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Adiposity; Fatty Liver; Alcohol Use Disorder

Keywords

GLP-1; Semaglutide

Outcome Measures

Primary Outcomes (1)

• 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.

  From inclusion date (baseline) until end of the study, total duration 16 weeks per patient

Secondary Outcomes (17)

• Proportion of patients achieving total alcohol abstinence (measured by TFLB method)

  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)

  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)

  From inclusion date (baseline) until end of the study, total duration 16 weeks per patient

• Change of heavy drinking days (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)

  From inclusion date (baseline) until end of the study, total duration 16 weeks per patient

Study Arms (2)

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.

Drug: Semaglutide; Behavioral: Weight reduction recommendations (nutritional and exercise)

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.

Behavioral: Weight reduction recommendations (nutritional and exercise)

Interventions

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.

Semaglutide Arm

Weight reduction recommendations (nutritional and exercise) BEHAVIORAL

Participants will receive nutritional and exercise recommendations and 2 telephone consultations

Control Arm; Semaglutide Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Hospital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Obesity; Fatty Liver; Alcoholism

Interventions

semaglutide; Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Susana Gomes Rodrigues, MD

  University Hospital Bern (Inselspital), Hepatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susana Gomes Rodrigues, MD

CONTACT

+41 31 632 59 54; susana.gomesrodrigues@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No blinding procedures in place
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an exploratory, monocentric, randomized controlled clinical trial

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)