GLP-1 RA

Not yet recruitingPhase NA

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

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

estimated

Study population

Alcohol / substance use, MASH / NAFLD / liver fibrosis, Obesity / overweight

Key I/E criterion

•BMI ≥35

Primary endpoint

•Total alcohol abstinence

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06546384

Org study ID2023-01715

Timeline

Milestones

Study first posted2024-08-09actual

Last update posted2026-02-25actual

Study start2026-05-01estimated

Primary completion2026-12-31estimated

Study completion2027-04-30estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Alcohol / substance useMASH / NAFLD / liver fibrosisObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (18)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

MASH / liver

Other (unclassified)

Safety / tolerability / PK

MASH / liver

2 endpoints

Secondary/protocol endpoint

Percentage reduction in transient liver elastography levels assessed by Fibroscan

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

Liver stiffness (VCTE), change

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percentage reduction in transient liver elastography levels assessed by FIB-4 score

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

percent change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Safety profile of semaglutide in described population

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

Serious AEs (any)

event count, event

Other clinical outcomes

13 endpoints

Primary/protocol endpoint

Proportion of patients achieving total alcohol abstinence (measured by negative PEth test)

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

threshold achievement, improvement

Secondary/protocol endpoint

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

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

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of patients maintaining total alcohol abstinence (measured by negative EtG)

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

threshold achievement, improvement

Secondary/protocol endpoint

Change of alcohol abstinent days (cumulative abstinent days, by TFLB method)

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

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint

Change of heavy drinking days (by TFLB method)

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

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint

Change of total number of drinks per week (by TFLB method)

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

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint

Pre and post treatment comparison of total abstinence (PEth test)

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

threshold achievement, improvement

Secondary/protocol endpoint

Pre and post treatment comparison of total abstinence (assessed by TFLB method)

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

threshold achievement, improvement

Secondary/protocol endpoint

Pre and post treatment comparison of total abstinence (measured by negative EtG)

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

threshold achievement, improvement

Secondary/protocol endpoint

Pre and post treatment comparison of cumulative abstinent days (by TFLB method)

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

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint

Pre and post treatment comparison of drinking days (by TFLB method)

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

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint

Pre and post treatment comparison of number of drinks per week (by TFLB method)

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

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Effects of semaglutide on reward and relief drinking behavior

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

AUDIT score

change from baseline, improvement

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Percentage reduction in metabolic markers

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

percent change from baseline, improvement

componentsBody weight, % change, BMI, change, Fasting glucose, change, HOMA-IR (insulin sensitivity), HbA1c, % change

Secondary/protocol endpoint/low confidence

Effect of GLP-1 RA therapy on TMA/TMAO pathway

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

percent change from baseline, improvement

Publications (10)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Mechanisms of GLP-1 Receptor Agonist-Induced Weight Loss: A Review of Central and Peripheral Pathways in Appetite and Energy Regulation.
The American journal of medicine2025 Jun (month)PMID39892489doi:10.1016/j.amjmed.2025.01.021via pubmed acronym asset candidate
What is the pipeline for future medications for obesity?
International journal of obesity (2005)2025 Mar (month)PMID38302593doi:10.1038/s41366-024-01473-yvia pubmed acronym asset candidate
Efficacy and Safety of Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss Among Adults Without Diabetes : A Systematic Review of Randomized Controlled Trials.
Annals of internal medicine2025 Feb (month)PMID39761578doi:10.7326/ANNALS-24-01590via pubmed acronym asset candidate
Discontinuation and Reinitiation of Dual-Labeled GLP-1 Receptor Agonists Among US Adults With Overweight or Obesity.
JAMA network open2025 Jan 2PMID39888616doi:10.1001/jamanetworkopen.2024.57349via pubmed acronym asset candidate
Emerging pharmacotherapies for obesity: A systematic review.
Pharmacological reviews2025 Jan (month)PMID39952695doi:10.1124/pharmrev.123.001045via pubmed acronym asset candidate
GLP-1, GIP/GLP-1, and GCGR/GLP-1 receptor agonists: Novel therapeutic agents for metabolic dysfunction-associated steatohepatitis.
World journal of gastroenterology2024 Dec 28PMID39735270doi:10.3748/wjg.v30.i48.5205via pubmed acronym asset candidate
Safety and efficacy of glucagon-like peptide-1 (GLP-1) receptor agonists in patients with weight regain or insufficient weight loss after metabolic bariatric surgery: A systematic review and meta-analysis.
Obesity reviews : an official journal of the International Association for the Study of Obesity2024 Nov (month)PMID39134066doi:10.1111/obr.13811via pubmed acronym asset candidate
Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide.
JAMA ophthalmology2024 Aug 1PMID38958939doi:10.1001/jamaophthalmol.2024.2296via pubmed acronym asset candidate
Efficacy and Safety of Glucagon-Like Peptide-1 Receptor Agonists on Body Weight and Cardiometabolic Parameters in Individuals With Obesity and Without Diabetes: A Systematic Review and Meta-Analysis.
Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists2024 Feb (month)PMID38029929doi:10.1016/j.eprac.2023.11.007via pubmed acronym asset candidate
Tirzepatide, a dual GIP/GLP-1 receptor co-agonist for the treatment of type 2 diabetes with unmatched effectiveness regrading glycaemic control and body weight reduction.
Cardiovascular diabetology2022 Sep 1PMID36050763doi:10.1186/s12933-022-01604-7via pubmed acronym asset candidate

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.