An interventional study of Semaglutide and Weight reduction recommendations (nutritional and exercise) in Adiposity, Fatty Liver and Alcohol Use Disorder, sponsored by Insel Gruppe AG, University Hospital Bern. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Treatment
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.
In Switzerland, approximately 20% of the population is consuming more alcohol than recommended by the WHO. There is evidence that alcoholic beverage consumption significantly interacts with food energy intake. 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. Exendin-4 binds to the GLP-1R with high affinity and acts as a receptor agonist, thus referred to as GLP-1 receptor agonists (GLP-1 RA). To date the GLP-1 RA: dulaglutide, semaglutide, liraglutide, lixisenatide and exenatide are approved for the treatment of diabetes mellitus type II in Switzerland. Since 2020, the GLP-1 RA semaglutide is also approved for the treatment of obesity in Switzerland. GLP-1 RA have a well-established effect on the food reward system which is regulated by key mesolimbic brain regions, the ventral tegmental area (VTA) and nucleus accumbens (NAc)11. Interestingly, these regions are also involved in the rewarding effects of drugs of abuse and alcohol. A link between alcohol intake and GLP-1 has been demonstrated in several preclinical studies and may play an important role in the development of addiction. The findings are consistent with the hypothesis that systemic administration of GLP-1 RA can influence the mesolimbic dopamine system and reward-seeking behaviours associated with alcohol use disorder (AUD). Furthermore, preclinical data has shown that GLP-1 RA, namely, liraglutide significantly improved liver microvascular function and exhibited anti-fibrotic effects of confirmed in human liver tissue.
In metabolic fatty liver disease, GLP-1 RA have a significant effect on reducing steatosis and inflammation. Obesity is one of the main risk factors for fatty liver disease, particularly central adiposity, and one of the leading drivers for liver disease progression, independent of the cause of liver disease. In a Swiss referral liver centre, 75% of patients with advanced cirrhosis have either alcohol, metabolic or combined factors (25%) as the cause for liver disease. Therapeutic strategies approaching both aetiologies are thus urgently needed.
The investigators aim to investigate in this study, whether there is a significant beneficial effect of GLP-1 RA, specifically semaglutide, on alcohol consumption, specifically in obese patients. Furthermore, the investigators aim to systematically assess drinking patterns and alcohol beverage consumption in patients with obesity assessed with the innovative direct alcohol biomarker phosphatidylethanol (PEth)24 that overcomes the problems of low reliability of medical history, standard questionnaires and previous tests in assessing recent alcohol consumption.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 64 is close to the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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.
Participants will receive nutritional and exercise recommendations and 2 telephone consultations
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.
Time frame: From inclusion date (baseline) until end of the study, total duration 16 weeks per patient
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 semaglutide vs control.
Time frame: 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 semaglutide vs. control
Time frame: 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 semaglutide vs. control (measured by TFLB method)
Time frame: 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 semaglutide vs. control (measured by TFLB method)
Time frame: 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 semaglutide vs. control (measured by TFLB method)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: From inclusion date (baseline) until end of the study, total duration 16 weeks per patient
Effects of semaglutide on reward and relief drinking behavior
Assessments of effects of semaglutide on reward and relief drinking behavior (assessed with the Alcohol Expectancy Questionnaire, both study arms).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: From inclusion date (baseline) until end of the study, total duration 16 weeks per patient
Safety profile of semaglutide in described population
Number and description of SAE's concerning semaglutide in described population (semaglutide arm only).
Time frame: 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, semaglutide arm only).
Time frame: From inclusion date (baseline) until end of the study, total duration 16 weeks per patient
Plan to share: No
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Start is estimated for Nov 2026; primary completion for Dec 2026, 1 month later.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 1 month is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Semaglutide
Insel Gruppe AG, University Hospital Bern →