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GLP-1 RA on Alcohol Consumption, Metabolism and Liver Parameters in Patients With Obesity and Fatty Liver Disease
Plain-language guide to NCT06546384: not phased randomized trial of Semaglutide, fatty liver & elevated liver enzymes, 64 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06546384
- Phase
- not phased
- Status
- not yet recruiting
- Start
- 2026-11-01
- Completion (planned or actual)
- 2026-12-31
- Participants
- 64 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Adiposity; Fatty Liver; Alcohol Use Disorder
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Semaglutide for fatty liver & elevated liver enzymes.
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.
It had two arms (groups): Semaglutide Arm (experimental) and Control Arm (active comparator).
The registry classes the interventions as behavioral and drug.
More on the Plan
Although several studies have investigated the role of alcohol in obesity, there is still a lack of knowledge about specific roles of different types of alcoholic beverages and on the effect of consumption patterns in patients with metabolic syndrome and obesity.
Nevertheless, there is accumulating evidence showing independent, combined, and modifying effects of alcohol and metabolic factors on the onset and progression of chronic liver disease.
Glucagon-like peptide-1 (GLP-1)-based therapy for type 2 diabetes was introduced in 2006.
GLP-1 is an incretin hormone, which is secreted from endocrine L cells of the small intestine in response to nutrients in the gut lumen.
Who Took Part
The registry lists 64 planned participants were the target.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 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).
The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: 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).
How the Study Was Run
Design: randomized, parallel-group and open-label.
Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Groups ran in parallel: each of the fatty liver & elevated liver enzymes participants stayed in one arm throughout.
Being open-label, the Semaglutide study did not mask who received what.
It started in 2026-11-01 with completion listed for 2026-12-31.
It ran at 1 site in Switzerland.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): 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).
It also tracked 17 secondary outcomes, for example Proportion of patients achieving total alcohol abstinence (measured by TFLB method), Proportion of patients maintaining total alcohol abstinence (measured by negative EtG), Change of alcohol abstinent days (cumulative abstinent days, by TFLB method), Change of heavy drinking days (by TFLB method), Change of total number of drinks per week (by TFLB method) and Pre and post treatment comparison of total abstinence (PEth test).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Semaglutide in 64 people with fatty liver & elevated liver enzymes.
Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Semaglutide compound page, Fatty liver & elevated liver enzymes research.
Our Notes on the Compound
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.