Metabolic Associated Fatty Liver DiseaseMETAfoieNCT06764056
Characterization and Management of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)
A study testing semaglutide and Diet in people with Metabolic Associated Fatty Liver Disease and Metabolic Associated-dysfunction Steatohepatitis (MASH), run by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval at 1 site in Canada.
Trial summary
The goal of this clinical trial is to improve the treatment of hepatic steatosis associated with obesity with pharmacological and nutritionnal approaches. The main question it aims to answer is: Does an individualized nutritionnal approach with a dietician combined with medication targeting obesity is the most… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Associated Fatty Liver Disease, Metabolic Associated-dysfunction Steatohepatitis (MASH), Obesity
- What is being tested?
- semaglutide and Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2025to May 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index between 30 and 50 kg/m2;
- Stade 2 or 3 (S2 or S3) hepatic steatosis with or without liver fibrosis.
Who cannot join
- Type 1 diabetes diagnosis;
- Alcohol consumption exceeding recommendations [>140 g/week (women) and >210 g/week (men)];
- Known chronic hepatic disease non-steatotic at the entry of the study (Wilson's disease, hemochromatosis, alpha-1-antitrypsin deficiency, viral hepatitis, auto-immune hepatitis, etc.);
- Pharmacological treatment targeting obesity active or ended in the last 3 months;
- Bariatric surgery;
- Gastro-intestinal pathologies (GI cancers, IBD, etc.);
Show all 10Show fewer
- Capsulated probiotics consumption;
- Antibiotic treatment in the last 3 months;
- Pregnancy;
- Cirrhosis diagnosis (hepatic decompensation).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec, G1V 4G5
Tristan Rocheleau, RD., Ph.D.(c), 5819969946, tristan.rocheleau.2@ulaval.ca
Fannie Lajeunesse-Trempe, MD., Ph.D.
About this study
Official title: Characterization and Management of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) Through an Individualized Nutritionnal Approach and Semaglutide Therapy.
The goal of this clinical trial is to improve the treatment of hepatic steatosis associated with obesity with pharmacological and nutritionnal approaches. The main question it aims to answer is:
Does an individualized nutritionnal approach with a dietician combined with medication targeting obesity is the most efficient way to treat hepatic steatosis associated with obesity?
Read more
Participants will either participate in one of three groups:
- Nutrition: Participant will only have a regular follow-up with a registered dietician;
- Nutrition + Semaglutide: Participants will start a new medication targeting obesity and will have a regular follow-up with a registered dietician;
- Semaglutide: Participants will start a new medication targeting obesity.
Read the detailed description
Participants in each group will be followed during a year for 4 timepoints (0, 3, 6 and 12 months). Blood and feces samples, anthropometric measures, transient elastography measurements and health questionnaires will be assessed at each timepoint.
The nutritionnal intervention targeting hepatic steastosis associated with obesity will use conclusions from a systematic review we conducted on nutritionnal approaches to treat liver steatosis.
- Conditions
- Metabolic Associated Fatty Liver Disease, Metabolic Associated-dysfunction Steatohepatitis (MASH), Obesity
- Being tested
- semaglutide, Diet
- Keywords
- Obesity, Metabolic associated fatty liver disease, GLP-1 receptor analogs, Pharmacotherapy, Nutrition, Transient elastography, Semaglutide, Microbiome, Lipidomics
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaglutideDrug
Participants receiving this intervention will be starting with a dose of semaglutide 0.25 mg. Physicians will follow Wegovy® Dosing Schedule guidelines, ending with a final dose of 2.4 mg at the fifth month. Type 2 diabetes participants wishing to stop at 1.0 mg will be allowed.
DietOther
Also called Individualized nutritionnal intervention, Nutritionnal counselling
Participants receiving this intervention will be seeing a registered dietician at each visit. The individualized approach will be based on recent literature (mostly hypocaloric) by using different methods.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition | Active comparator | This arm will only participate in an individualized nutritionnal approach. Receives: Other: Diet |
| Nutrition + Semaglutide | Active comparator | This arm will initiate a pharmacological intervention to treat obesity (Semaglutide) and will participate in an individualized nutritionnal approach. Receives: Drug: semaglutide; Other: Diet |
| Semaglutide | Active comparator | This arm will only initiate a pharmacological intervention to treat obesity (Semaglutide) Receives: Drug: semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Steatosis
Transient elastography is an ultrasound-based modality that is non-invasive and measures the degree of steatosis with the controlled attenuation parameter (CAP; dB/m) and liver stiffness (kPa).This method will be used at each visit to follow the progression and the efficiency of the interventions.
The following ranges will be use to classify hepatic steatosis based on CAP (dB/m) (specific to FibroScan®): S0 (< 302), S1 (302-331), S2 (331-337) and S3 (>337).
Measured: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Liver Stiffness
Transient elastography is an ultrasound-based modality that is non-invasive and measures the degree of steatosis with the controlled attenuation parameter (CAP; dB/m) and liver stiffness (kPa).This method will be used at each visit to follow the progression and the efficiency of the interventions.
The following ranges will be use to classify hepatic fibrosis based on liver stiffness (kPa) (specific to FibroScan®): F0-F1 (< 8.0), F2 (8.9-9.7), F3 (9.7-13.6) and F4 (>13.6).
Measured: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Secondary outcomes (11)
Liver function (biochemistry)
Blood samples will be drawn at each visit to assess the following measures:
liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutamyl transferase [GGT], alkaline phosphatase [ALP]), total bilirubin and albumin. Liver scores will also be calculated: fatty liver index (FLI) and fibrosis-4 index (FIB-4)
The following normal ranges will be used:
- AST : [8-33] U/L;
- ALT : [10-40] U/L;
- GGT : [2-30] U/L;
- ALP : [30-120] U/L;
- Total bilirubin : [5-21] umol/L;
- Albumin : [35-30] g/L.
- FLI : <30 : Low risk of hepatic steatosis ; >60 : High risk of hepatic steatosis.
- FIB-4 : >3.48 : High risk of cirrhosis
Measured: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Lipid panel
Blood samples will be drawn at each visit to assess the lipid panel.
The following ranges will be used:
- triglycerides: < 1.5 mmol/L;
- total cholesterol: < 5.20 mmol/L;
- LDL-cholesterol: < 2.59 mmol/L;
- HDL-cholesterol: > 1.55 mmol/L;
Measured: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Change from Baseline in the gut microbiota diversity
The composition of the gut microbiota will be measured at each visit with the participants' stool samples. The difference between the concentration of gut microbiota diversity (bacteria, families, phyllum, etc.) will be analyzed.
Measured: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Change from Baseline in blood lipids and metabolites
We will perform lipidomic and metabolomic measures with blood samples of each visit with liquid chromatography coupled with mass spectrometry (LC-MS/MS).
Measured: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Glucose
Blood samples will be drawn at each visit to assess the glucose.
The following range will be used:
- glucose: < 5.6 mmol/L;
Measured: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Insulin
Blood samples will be drawn at each visit to assess insulin
The following range will be used:
- insuline: [20-60] pmol/L;
Measured: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Glycated hemoglobin
Blood samples will be drawn at each visit to assess HbA1c
The following range will be used:
- HbA1c: < 6.5 %;
Measured: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
C-reactive protein
Blood samples will be drawn at each visit to assess the c-reactive protein
The following range will be used:
- CRP: < 10 mg/L.
Measured: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Liver enzymes
Blood samples will be drawn at each visit to assess the following measures:
liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutamyl transferase [GGT] and alkaline phosphatase [ALP]),
The following normal ranges will be used:
- AST : [8-33] U/L;
- ALT : [10-40] U/L;
- GGT : [2-30] U/L;
- ALP : [30-120] U/L.
Measured: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Fatty liver index (FLI)
The Fatty liver index (FLI) is a non-invasive score to calculate liver steatosis (using BMI, WC, TG and GGT).
The following ranges will be used:
- <30 : Low risk of hepatic steatosis ;
- >60 : High risk of hepatic steatosis.
Measured: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Fibrosis-4 index (FIB-4)
The fibrosis-4 index (FIB-4) is a non-invasive score to calculate liver fibrosis (using Age, AST, ALT and Platelet count).
The following normal range will be used:
- <30 : Low risk of hepatic steatosis ; >60 : High risk of hepatic steatosis. fatty liver index (FLI) and
The following range will be used:
- FIB-4 : >3.48 : High risk of cirrhosis
Measured: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Associated Fatty Liver DiseaseStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fannie Lajeunesse-Trempe, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Investigators
- Fannie Lajeunesse-Trempe, MD., Ph.D., Principal investigator, Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764056
- Sponsor's protocol ID
- 2025-4271
- Acronym
- METAfoie
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 8 Jan 2025
- 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 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Management of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) Through an Individualized Nutritionnal Approach and Semaglutide Therapy.
- ClinicalTrials.gov ID
- NCT06764056
- Acronym / sponsor ID
- METAfoie / 2025-4271
- Conditions
- Metabolic Associated Fatty Liver Disease, Metabolic Associated-dysfunction Steatohepatitis (MASH), Obesity
- Keywords
- Obesity, Metabolic associated fatty liver disease, GLP-1 receptor analogs, Pharmacotherapy, Nutrition, Transient elastography, Semaglutide, Microbiome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University LavalUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 8 Jan 2025 (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.
The goal of this clinical trial is to improve the treatment of hepatic steatosis associated with obesity with pharmacological and nutritionnal approaches. The main question it aims to answer is:
Does an individualized nutritionnal approach with a dietician combined with medication targeting obesity is the most efficient way to treat hepatic steatosis associated with obesity?
Participants will either participate in one of three groups:
- Nutrition: Participant will only have a regular follow-up with a registered dietician;
- Nutrition + Semaglutide: Participants will start a new medication targeting obesity and will have a regular follow-up with a registered dietician;
- Semaglutide: Participants will start a new medication targeting obesity.
Detailed description
Participants in each group will be followed during a year for 4 timepoints (0, 3, 6 and 12 months). Blood and feces samples, anthropometric measures, transient elastography measurements and health questionnaires will be assessed at each timepoint.
The nutritionnal intervention targeting hepatic steastosis associated with obesity will use conclusions from a systematic review we conducted on nutritionnal approaches to treat liver steatosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nutrition | Active comparator | Other: DietThis arm will only participate in an individualized nutritionnal approach. |
| Nutrition + Semaglutide | Active comparator | Drug: semaglutide, Other: DietThis arm will initiate a pharmacological intervention to treat obesity (Semaglutide) and will participate in an individualized nutritionnal approach. |
| Semaglutide | Active comparator | Drug: semaglutideThis arm will only initiate a pharmacological intervention to treat obesity (Semaglutide) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index between 30 and 50 kg/m2;
- Stade 2 or 3 (S2 or S3) hepatic steatosis with or without liver fibrosis.
Key exclusion criteria (10 listed)
- Type 1 diabetes diagnosis;
- Alcohol consumption exceeding recommendations [>140 g/week (women) and >210 g/week (men)];
- Known chronic hepatic disease non-steatotic at the entry of the study (Wilson's disease, hemochromatosis, alpha-1-antitrypsin deficiency, viral hepatitis, auto-immune hepatitis, etc.);
- Pharmacological treatment targeting obesity active or ended in the last 3 months;
- Bariatric surgery;
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 |
|---|---|---|
| semaglutideParticipants receiving this intervention will be starting with a dose of semaglutide 0.25 mg. Physicians will follow Wegovy® Dosing Schedule guidelines, ending with a final dose of 2.4 mg at the fifth month. Type 2 diabetes participants wishing to stop at 1.0 mg will be allowed. | Drug | Nutrition + Semaglutide, Semaglutide |
| DietAlso: Individualized nutritionnal intervention, Nutritionnal counsellingParticipants receiving this intervention will be seeing a registered dietician at each visit. The individualized approach will be based on recent literature (mostly hypocaloric) by using different methods. | Other | Nutrition, Nutrition + Semaglutide |
Primary outcome
Liver Steatosis
Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Transient elastography is an ultrasound-based modality that is non-invasive and measures the degree of steatosis with the controlled attenuation parameter (CAP; dB/m) and liver stiffness (kPa).This method will be used at each visit to follow the progression and the efficiency of the interventions. The following ranges will be use to classify hepatic steatosis based on CAP (dB/m) (specific to FibroScan®): S0 (< 302), S1 (302-331), S2 (331-337) and S3 (>337).
Liver Stiffness
Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Transient elastography is an ultrasound-based modality that is non-invasive and measures the degree of steatosis with the controlled attenuation parameter (CAP; dB/m) and liver stiffness (kPa).This method will be used at each visit to follow the progression and the efficiency of the interventions. The following ranges will be use to classify hepatic fibrosis based on liver stiffness (kPa) (specific to FibroScan®): F0-F1 (< 8.0), F2 (8.9-9.7), F3 (9.7-13.6) and F4 (>13.6).
11 secondary outcomes
Liver function (biochemistry)
Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Lipid panel
Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Change from Baseline in the gut microbiota diversity
Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Change from Baseline in blood lipids and metabolites
Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Glucose
Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Insulin
Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Glycated hemoglobin
Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
C-reactive protein
Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Liver enzymes
Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Fatty liver index (FLI)
Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Fibrosis-4 index (FIB-4)
Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
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 8 Jan 2025.
- 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.
Fannie Lajeunesse-Trempe, MD., Ph.D. principal investigator
Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
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 Diet in people with Metabolic Associated Fatty Liver Disease and Metabolic Associated-dysfunction Steatohepatitis (MASH), run by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval at 1 site in Canada.
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 2 inclusion and 10 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 8 Jan 2025. 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 Canada. 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 Tristan Rocheleau, RD., M.Sc. (418-656-8711, #2681, tristan.rocheleau.2@ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver Steatosis (time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)). The study lists 2 primary outcomes in all. 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 8 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.