AdiposityGLP-1 RANCT06546384
GLP-1 RA on Alcohol Consumption, Metabolism and Liver Parameters in Patients With Obesity and Fatty Liver Disease
A study testing Semaglutide and Weight reduction recommendations (nutritional and exercise) in people with Adiposity and Fatty Liver, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adiposity, Fatty Liver, Alcohol Use Disorder
- What is being tested?
- Semaglutide and Weight reduction recommendations (nutritional and exercise)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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)
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
University Hospital Bern
Bern, 3010
Susana Gomes Rodrigues, MD, +41 31 632 59 54, susana.gomesrodrigues@insel.ch
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Adiposity, Fatty Liver, Alcohol Use Disorder
- Being tested
- Semaglutide, Weight reduction recommendations (nutritional and exercise)
- Keywords
- GLP-1, Semaglutide
- Medical subject headings
- Obesity, Fatty Liver, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
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.
Weight reduction recommendations (nutritional and exercise)Behavioural
Participants will receive nutritional and exercise recommendations and 2 telephone consultations
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Weight reduction recommendations (nutritional and exercise) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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).
Measured: 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).
Measured: From inclusion date (baseline) until end of the study, total duration 16 weeks per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdiposityStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an exploratory, monocentric, randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susana Gomes Rodrigues, MD, Principal investigator, University Hospital Bern (Inselspital), Hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546384
- Sponsor's protocol ID
- 2023-01715
- Other IDs
- 2023
- Acronym
- GLP-1 RA
- Status last verified
- Feb 2026
- First submitted
- 6 Aug 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06546384
- Acronym / sponsor ID
- GLP-1 RA / 2023-01715
- Conditions
- Adiposity, Fatty Liver, Alcohol Use Disorder
- Keywords
- GLP-1, Semaglutide
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an exploratory, monocentric, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Semaglutide Arm | Experimental | Drug: Semaglutide, Behavioral: Weight reduction recommendations (nutritional and exercise)Patients assigned to this arm will be treated with semaglutide and standard of care for weight reduction (nutritional and exercise recommendations) for 16 weeks. |
| Control Arm | Active comparator | 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideTreatment 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. | Drug | Semaglutide Arm |
| Weight reduction recommendations (nutritional and exercise)Participants will receive nutritional and exercise recommendations and 2 telephone consultations | Behavioural | Control Arm, Semaglutide Arm |
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
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.
17 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Percentage reduction in metabolic markers
Time frame: From inclusion date (baseline) until end of the study, total duration 16 weeks per patient
Safety profile of semaglutide in described population
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
Time frame: From inclusion date (baseline) until end of the study, total duration 16 weeks per patient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susana Gomes Rodrigues, MD principal investigator
University Hospital Bern (Inselspital), Hepatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semaglutide and Weight reduction recommendations (nutritional and exercise) in people with Adiposity and Fatty Liver, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susana Gomes Rodrigues, MD (+41 31 632 59 54, susana.gomesrodrigues@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.