Phase 4Recruiting

Comparing Metabolic surgery with Incretin-Based Therapy for metabolic dysfunction-associated steatotic liver disease

Official title: Fibrosis Lessens After Metabolic Surgery

A Prospective Multicenter International Randomized Controlled Trial Comparing Surgical and Medical Therapies in the Treatment of Advanced Metabolic Dysfunction Associated Steatohepatitis

Condition: Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)Sponsor: The Cleveland ClinicTarget enrollment: 120

Phase 4
2 groups
One site, in Montreal
Recruiting

Interventions

Medical procedure
Metabolic surgery
Patients receive either RYGB or SG. The surgical risk, differential impact of each procedure on body weight and other obesity-related diseases, presence of other medical and mental problems, patient's behavioral factors (e.g., postoperative compliance, active smoking), medications, and goals will be considered when the patient and local medical team make a shared decision about the most appropriate surgical procedure
Medication
Incretin-Based Therapy
Three incretin-based medications that have been approved for treatment of obesity including liraglutide, semaglutide, or tirzepatide will be used in the nonsurgical group. Any of these 3 medications (in the injection or oral from) based on availability in each country, access, and clinical indications can be used. If possible, patients will be placed on high-dose tirzepatide (Mounjaro or Zepbound 15 mg once weekly injection) or high-dose semaglutide (Wegovy 2.4 mg once weekly injection or Ozempic 2 mg once weekly injection). Other acceptable, less preferrable, options: liraglutide (Saxenda or Victoza), semaglutide tablet (Rybelsus), or lower dose of tirzepatide and semaglutide injections.

Canadian Sites (1)

1 listed, none recruiting

McGill University
Montreal
Not yet recruiting

See who this study is looking for199 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

+liver stiffness (by transient elastography using FibroScan®) is between 12 and 15 kPa and their platelet count is \>150,000 per μL, or
+Known or suspected allergy to semaglutide, tirzepatide, liraglutide, excipients, or related products
+Chronic renal insufficiency with eGFR below 30 mL/min/1.73 m2, or being on dialysis
+Known history of other chronic liver diseases (drug induced, viral hepatitis, autoimmune, and genetic):
+Hepatitis B as detected by presence of hepatitis B surface antigen (HBsAg)
+Hepatitis C as detected by presence of hepatitis C virus (HCV) RNA (in case the screening test for hepatitis C is positive, the confirmative test is decisive)
+Entry into the study would require that the patient:
+Is a candidate for general anesthesia
+Is ≥18 and ≤75 years old at the time of signing the informed consent
+Has a BMI ≥35 and ≤70 kg/m2 at the time of first study visit
+FIB-4 ≥ 1.3
+At least one of the following 5 criteria suggesting presence of advanced fibrosis:
+LSM ≥ 12 kPa by VCTE using FibroScan®
+LSM ≥ 12 kPa by SWE
+LSM ≥ 1.7 m/s by ARFI
+LSM ≥ 3.63 kPa MRE
+ELF score ≥ 9.8
+Patients with and without T2DM are eligible for the study. Patients with T2DM should have been on a stable dose of anti-diabetic medication (including insulin but not semaglutide or tirzepatide or liraglutide) for at least 3 months prior to entry, with glycated hemoglobin (HbA1c) ≤12%.
+Self-reported stable weight in 6 months before the first study visit (no weight loss \>10% within 6 months prior to the first study visit)
+a. In patients with a historical noninvasive tests or liver biopsy, weight loss of no more than 10% is allowed from 6 months prior to the historical tests until the first study visit
+Has the ability and willingness to participate in the study, provide informed consent, and agree to any of the arms involved in the study
+Can understand the options and comply with the requirements of each arm, including one liver biopsy performed during the screening period (if no adequate biopsy within 12 months before screening is available) and one liver biopsy after 2-years
+Exclusion Criteria
+Patients who meet the following criteria will be excluded from the study:
+Autoimmune liver disease as diagnosed by antibodies or compatible liver histology
+Primary biliary cirrhosis as defined by the presence of at least 2 criteria (elevated alkaline phosphatase, presence of anti-mitochondrial antibody, and histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts)
+Primary sclerosing cholangitis
+Wilson's disease as diagnosed by low ceruloplasmin or compatible liver histology
+Alpha-1-antitrypsin deficiency as diagnosed by alpha1-antitrypsin level or liver histology
+Hemochromatosis as diagnosed by HFE mutations (C282Y, H63D), ferritin and transferrin saturation levels, or presence of 3+ or 4+ stainable iron on liver biopsy
+Drug-induced liver disease diagnosed by medical history
+Known bile duct obstruction
+Suspected or proven liver cancer
+Weight change \>10% within 6 months prior to the first study visit or prior to the historical liver biopsy
+Treatment with semaglutide, tirzepatide, or liraglutide (for obesity or for T2DM) \<90 days before the first study visit.
+However, patients are allowed to participate if they have been on a low dose (or are on older generation GLP-1 agonists) and have lost less than 10% of their body weight since starting the medication.
+Type 1 diabetes or autoimmune diabetes
+Known cases of human immunodeficiency virus infection
+Reversed procedures such as gastric band or intragastric balloon that have been removed at least 3 months prior to the first study visit are allowed.
+History of solid organ transplant
+Severe pulmonary disease defined as FEV1 \< 50% of predicted value
+Significant cardiac or atherosclerotic disease (planned to undergo cardiac, coronary, carotid, or peripheral artery revascularization procedures in the next 12 months)
+Severe uncompensated cardiopulmonary disease leading to American Society of Anesthesiologists Class IV or V
+Classified as New York Heart Association Class IV
+Left ventricular ejection fraction \<25% at the time of screening
+Presence of large hiatal hernia (\>7 cm)
+Presence of Crohn's disease
+Diagnosis of malignancy within the preceding 3 years (except squamous cell and basal cell cancer of the skin)
+Anemia defined as hemoglobin less than 9 g/dL
+On therapeutic dose of anticoagulants such as warfarin or direct oral anticoagulants (DOACs)
+Known history of clotting disorders, including pulmonary embolus and deep vein thrombosis
+Clinical judgment that life expectancy is less than 3 years
+Use of investigational therapy within 3 months prior to signing the consent
+History of pancreatic carcinoma
+Acute pancreatitis \< 180 days before screening
+History or presence of chronic pancreatitis
+Presence of concerning thyroid nodule
+Uncontrolled thyroid disease: thyroid stimulating hormone (TSH) \> 6.0 mIU/L or \< 0.1 mIU/L before the first study visit
+Patients receiving treatment for hypothyroidism can be included if their thyroid hormone replacement dose has been stable for at least 3 months.
+Patients whose TSH is outside the rang but they have normal levels of thyroid hormones can be included.
+A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
+Evidence or history of ascites or spontaneous bacterial peritonitis that require(d) treatment
+Trace ascites identified only by an abdominal imaging without other evidence of clinically significant portal hypertension and esophageal varices is not an exclusion criterion.
+Evidence or history of hepatic encephalopathy
+Evidence or history of variceal bleeding
+Evidence or history of portosplenic vein thrombosis
+Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to the first study visit.
+Defined as more than 14 units/week for females (\>1 drink per day) and more than 21 units/week for males (\>2 drinks per day) on average, where one unit of alcohol is equivalent to a 12-oz beer, 4-ounce glass of wine, or 1-ounce shot of hard liquor.
+Treatment with medications (for more than 14 consecutive days) with known effect on liver steatosis (e.g., treatment with systemic corticosteroids \[oral or intravenous\], methotrexate, tamoxifen, valproic acid, amiodarone, or tetracycline) in the 3 months prior to the first study visit (or historical liver biopsy).
+ALT or AST or Alkaline phosphatase \>200 U/L
+Recurrent major hypoglycemia or hypoglycemic unawareness
+Inability to safely obtain a liver biopsy
+Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study
+Unable to understand the risks, benefits, and compliance requirements of study
+Lack capacity to give informed consent
+Plans to move outside the primary location of study (country) within the next 24 months
+Previous participation in this trial and got randomized to one of the study groups but did not proceed.
+Hospitalization due to COVID-19 within 2 months prior to screening.
+Platelet count \<80,000
+International Normalized Ratio (INR) \>1.7
+Child-Pugh score B or C
+MELD score ≥15
+Upper endoscopy showing gastroesophageal varices
+Upper endoscopy showing more than mild portal hypertensive gastropathy
+Liver vascular ultrasound (duplex ultrasonography) showing significant portal hypertension characterized by dilated portal vein (\>13 mm), biphasic or reverse flow in the portal vein, enlarged paraumbilical veins, splenorenal collaterals, or dilated left and short gastric veins.
+Note: Negative findings on upper endoscopy and liver duplex ultrasound (done within one year of the first study visit for both tests) are necessary to establish eligibility for the FLAMES.
+Ruling out clinically significant portal hypertension is particularly important in patients with a liver stiffness ≥20 kPa or with a platelet count \<150,000 per μL or with a (historical) liver biopsy showing cirrhosis.
+A subset of patients without having upper endoscopy and liver duplex ultrasound can be eligible for enrollment if their:
+a (historical) liver biopsy showing absence of cirrhosis, or
+a (historical) HVPG \< 5 mmHg
+Cross-sectional abdominal imaging (if available historically) indicating presence of large portosystemic collaterals or ascites
+Splenomegaly alone (in the absence of other radiological and laboratory findings) is not considered to be a sign of clinically significant portal hypertension and is not an exclusion criterion.
+HVPG ≥ 12 mmHg (if available historically or if measured at the time of de novo liver biopsy)
+Liver biopsy characteristics:
+F0 in de novo biopsy; Enrollment cap of 20% for F1 in de novo biopsy.
+F0 and F1 in historical liver biopsy
+Absence of all three components of MASH (steatosis, hepatocyte ballooning, and lobular inﬂammation) in patients with F1, F2, and F3
+Absence of steatosis (\<5%) in patients with F4
+Diagnosis other than MASH
+Has a negative urine pregnancy test at the first and at the randomization visits for women of childbearing potential.
+Women of childbearing age must agree to use reliable method of contraception for 2 years
+Pregnancy, the intention of becoming pregnant, or not using adequate contraceptive measures
+Breastfeeding
+Is eligible for metabolic surgery (RYGB or SG) based on the ASMBS/IFSO 2022 guidelines
+Has insurance coverage for metabolic surgery (the requirements may vary in each country)
+Prior bariatric and metabolic surgery of any kind
+Prior complex foregut surgery including any esophageal and gastric surgeries, anti-reflux procedures, biliary diversion, and complex trauma surgery
+Any surgery requiring general anesthesia within 1 month prior to signing the consent
+Myocardial infarction, unstable angina, stroke, heart surgery, coronary stent placement in the past 6 months
+Psychiatric disorders including (but not limited to) dementia, active psychosis, severe depression requiring 3 or more medications, history of suicide attempts, active alcohol, or substance abuse within the previous 12 months that in the opinion of the investigators could disqualify the patient from metabolic surgery

Exclusion

−liver stiffness (by transient elastography using FibroScan®) is between 12 and 15 kPa and their platelet count is \>150,000 per μL, or
−Known or suspected allergy to semaglutide, tirzepatide, liraglutide, excipients, or related products
−Chronic renal insufficiency with eGFR below 30 mL/min/1.73 m2, or being on dialysis
−Known history of other chronic liver diseases (drug induced, viral hepatitis, autoimmune, and genetic):
−Hepatitis B as detected by presence of hepatitis B surface antigen (HBsAg)
−Hepatitis C as detected by presence of hepatitis C virus (HCV) RNA (in case the screening test for hepatitis C is positive, the confirmative test is decisive)
−Patients who meet the following criteria will be excluded from the study:
−Autoimmune liver disease as diagnosed by antibodies or compatible liver histology
−Primary biliary cirrhosis as defined by the presence of at least 2 criteria (elevated alkaline phosphatase, presence of anti-mitochondrial antibody, and histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts)
−Primary sclerosing cholangitis
−Wilson's disease as diagnosed by low ceruloplasmin or compatible liver histology
−Alpha-1-antitrypsin deficiency as diagnosed by alpha1-antitrypsin level or liver histology
−Hemochromatosis as diagnosed by HFE mutations (C282Y, H63D), ferritin and transferrin saturation levels, or presence of 3+ or 4+ stainable iron on liver biopsy
−Drug-induced liver disease diagnosed by medical history
−Known bile duct obstruction
−Suspected or proven liver cancer
−Weight change \>10% within 6 months prior to the first study visit or prior to the historical liver biopsy
−Treatment with semaglutide, tirzepatide, or liraglutide (for obesity or for T2DM) \<90 days before the first study visit.
−However, patients are allowed to participate if they have been on a low dose (or are on older generation GLP-1 agonists) and have lost less than 10% of their body weight since starting the medication.
−Type 1 diabetes or autoimmune diabetes
−Known cases of human immunodeficiency virus infection
−Reversed procedures such as gastric band or intragastric balloon that have been removed at least 3 months prior to the first study visit are allowed.
−History of solid organ transplant
−Severe pulmonary disease defined as FEV1 \< 50% of predicted value
−Significant cardiac or atherosclerotic disease (planned to undergo cardiac, coronary, carotid, or peripheral artery revascularization procedures in the next 12 months)
−Severe uncompensated cardiopulmonary disease leading to American Society of Anesthesiologists Class IV or V
−Classified as New York Heart Association Class IV
−Left ventricular ejection fraction \<25% at the time of screening
−Presence of large hiatal hernia (\>7 cm)
−Presence of Crohn's disease
−Diagnosis of malignancy within the preceding 3 years (except squamous cell and basal cell cancer of the skin)
−Anemia defined as hemoglobin less than 9 g/dL
−On therapeutic dose of anticoagulants such as warfarin or direct oral anticoagulants (DOACs)
−Known history of clotting disorders, including pulmonary embolus and deep vein thrombosis
−Clinical judgment that life expectancy is less than 3 years
−Use of investigational therapy within 3 months prior to signing the consent
−History of pancreatic carcinoma
−Acute pancreatitis \< 180 days before screening
−History or presence of chronic pancreatitis
−Presence of concerning thyroid nodule
−Uncontrolled thyroid disease: thyroid stimulating hormone (TSH) \> 6.0 mIU/L or \< 0.1 mIU/L before the first study visit
−Patients receiving treatment for hypothyroidism can be included if their thyroid hormone replacement dose has been stable for at least 3 months.
−Patients whose TSH is outside the rang but they have normal levels of thyroid hormones can be included.
−A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
−Evidence or history of ascites or spontaneous bacterial peritonitis that require(d) treatment
−Trace ascites identified only by an abdominal imaging without other evidence of clinically significant portal hypertension and esophageal varices is not an exclusion criterion.
−Evidence or history of hepatic encephalopathy
−Evidence or history of variceal bleeding
−Evidence or history of portosplenic vein thrombosis
−Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to the first study visit.
−Defined as more than 14 units/week for females (\>1 drink per day) and more than 21 units/week for males (\>2 drinks per day) on average, where one unit of alcohol is equivalent to a 12-oz beer, 4-ounce glass of wine, or 1-ounce shot of hard liquor.
−Treatment with medications (for more than 14 consecutive days) with known effect on liver steatosis (e.g., treatment with systemic corticosteroids \[oral or intravenous\], methotrexate, tamoxifen, valproic acid, amiodarone, or tetracycline) in the 3 months prior to the first study visit (or historical liver biopsy).
−ALT or AST or Alkaline phosphatase \>200 U/L
−Recurrent major hypoglycemia or hypoglycemic unawareness
−Inability to safely obtain a liver biopsy
−Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study
−Unable to understand the risks, benefits, and compliance requirements of study
−Lack capacity to give informed consent
−Plans to move outside the primary location of study (country) within the next 24 months
−Previous participation in this trial and got randomized to one of the study groups but did not proceed.
−Hospitalization due to COVID-19 within 2 months prior to screening.
−Platelet count \<80,000
−International Normalized Ratio (INR) \>1.7
−Child-Pugh score B or C
−MELD score ≥15
−Upper endoscopy showing gastroesophageal varices
−Upper endoscopy showing more than mild portal hypertensive gastropathy
−Liver vascular ultrasound (duplex ultrasonography) showing significant portal hypertension characterized by dilated portal vein (\>13 mm), biphasic or reverse flow in the portal vein, enlarged paraumbilical veins, splenorenal collaterals, or dilated left and short gastric veins.
−Note: Negative findings on upper endoscopy and liver duplex ultrasound (done within one year of the first study visit for both tests) are necessary to establish eligibility for the FLAMES.
−Ruling out clinically significant portal hypertension is particularly important in patients with a liver stiffness ≥20 kPa or with a platelet count \<150,000 per μL or with a (historical) liver biopsy showing cirrhosis.
−A subset of patients without having upper endoscopy and liver duplex ultrasound can be eligible for enrollment if their:
−a (historical) liver biopsy showing absence of cirrhosis, or
−a (historical) HVPG \< 5 mmHg
−Cross-sectional abdominal imaging (if available historically) indicating presence of large portosystemic collaterals or ascites
−Splenomegaly alone (in the absence of other radiological and laboratory findings) is not considered to be a sign of clinically significant portal hypertension and is not an exclusion criterion.
−HVPG ≥ 12 mmHg (if available historically or if measured at the time of de novo liver biopsy)
−Liver biopsy characteristics:
−F0 in de novo biopsy; Enrollment cap of 20% for F1 in de novo biopsy.
−F0 and F1 in historical liver biopsy
−Absence of all three components of MASH (steatosis, hepatocyte ballooning, and lobular inﬂammation) in patients with F1, F2, and F3
−Absence of steatosis (\<5%) in patients with F4
−Diagnosis other than MASH
−Pregnancy, the intention of becoming pregnant, or not using adequate contraceptive measures
−Breastfeeding
−Prior bariatric and metabolic surgery of any kind
−Prior complex foregut surgery including any esophageal and gastric surgeries, anti-reflux procedures, biliary diversion, and complex trauma surgery
−Any surgery requiring general anesthesia within 1 month prior to signing the consent
−Myocardial infarction, unstable angina, stroke, heart surgery, coronary stent placement in the past 6 months
−Psychiatric disorders including (but not limited to) dementia, active psychosis, severe depression requiring 3 or more medications, history of suicide attempts, active alcohol, or substance abuse within the previous 12 months that in the opinion of the investigators could disqualify the patient from metabolic surgery

5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning

What this study is

This study is testing a treatment for a condition.

Phase 4 — a study of a treatment already approved for use, following it in everyday practice.

From the trial registry

Built from these fields:

designModule.designInfo.primaryPurpose
designModule.phases

Who receives what

There are 2 groups in this study.

Group A, the comparison group, receives Metabolic surgery.

Registry label: A: Metabolic Surgery

Group B, the comparison group, receives Incretin-Based Therapy.

Registry label: B: Incretin-Based Therapy

From the trial registry

Built from these fields:

armsInterventionsModule.armGroups[].label
armsInterventionsModule.armGroups[].type
armsInterventionsModule.armGroups[].interventionNames

How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

One group of people involved — usually the participants — is not told which treatment is which.

From the trial registry

Built from these fields:

designModule.designInfo.allocation
designModule.designInfo.maskingInfo.masking

Is there a placebo?

This study does not list a placebo group.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

armsInterventionsModule.armGroups[].type
armsInterventionsModule.armGroups[].interventionNames

Who the study is looking for

The study lists an age range of 18 years to 75 years.

The study is open to people of any sex.

The study accepts healthy volunteers as well as people with the condition.

These are the criteria the study lists. Only the trial site can decide whether someone can take part.

From the trial registry

Built from these fields:

eligibilityModule.minimumAge
eligibilityModule.maximumAge
eligibilityModule.sex
eligibilityModule.healthyVolunteers

How big and how long

The study aims to enrol about 120 people.

The study is currently expected to finish around December 2029.

The main measurement is taken over: Through study completion, 2 years.

From the trial registry

Built from these fields:

designModule.enrollmentInfo.count
statusModule.completionDateStruct.date
outcomesModule.primaryOutcomes[].timeFrame

What the study measures

Improvement of at least 1 fibrosis stage of the Kleiner fibrosis classification and no worsening of MASH in the repeat liver biopsy — measured over Through study completion, 2 years.

From the trial registry

Built from these fields:

outcomesModule.primaryOutcomes[].measure
outcomesModule.primaryOutcomes[].timeFrame

Source: NCT06374875 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Metabolic surgeryProcedure

Patients receive either RYGB or SG. The surgical risk, differential impact of each procedure on body weight and other obesity-related diseases, presence of other medical and mental problems, patient's behavioral factors (e.g., postoperative compliance, active smoking), medications, and goals will be considered when the patient and local medical team make a shared decision about the most appropriate surgical procedure

From the trial registry — its own words, unedited.

What a procedure is here: A surgery, technique or clinical procedure being studied.

Read the full explanation → · in clinical review

About Incretin-Based TherapyDrug

Three incretin-based medications that have been approved for treatment of obesity including liraglutide, semaglutide, or tirzepatide will be used in the nonsurgical group. Any of these 3 medications (in the injection or oral from) based on availability in each country, access, and clinical indications can be used. If possible, patients will be placed on high-dose tirzepatide (Mounjaro or Zepbound 15 mg once weekly injection) or high-dose semaglutide (Wegovy 2.4 mg once weekly injection or Ozempic 2 mg once weekly injection). Other acceptable, less preferrable, options: liraglutide (Saxenda or Victoza), semaglutide tablet (Rybelsus), or lower dose of tirzepatide and semaglutide injections.

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial site can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: an age range of 18 years to 75 years.

The full inclusion and exclusion criteria are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

See how your details line up — get matched

From the trial registry

eligibilityModule.minimumAge
eligibilityModule.maximumAge
eligibilityModule.eligibilityCriteria

Is there a placebo?

This study does not list a placebo group.

One group receives an existing treatment so the two can be compared.

Save this trial to share with your doctor

From the trial registry

armsInterventionsModule.armGroups[].type

Would I know which treatment I am getting?

One group of people involved — usually the participants — is not told which treatment is which.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

Save this trial to share with your doctor

From the trial registry

designModule.designInfo.maskingInfo.masking
designModule.designInfo.allocation

Who can join?

The study lists an age range of 18 years to 75 years.

It is open to people of any sex.

It accepts healthy volunteers as well as people with the condition.

Only the trial site can confirm whether a particular person can take part.

See how your details line up — get matched

From the trial registry

eligibilityModule.minimumAge
eligibilityModule.maximumAge
eligibilityModule.sex
eligibilityModule.healthyVolunteers

How long would this take?

The study's main measurement is taken over: Through study completion, 2 years.

The study as a whole is currently expected to finish around 2029-12-31.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

Ask the study team directly

From the trial registry

outcomesModule.primaryOutcomes[].timeFrame
statusModule.completionDateStruct.date

How many people are taking part?

The study aims to enrol about 120 people.

Save this trial to share with your doctor

From the trial registry

designModule.enrollmentInfo.count

Where is this happening?

This study lists 2 locations, including: Montreal, Canada; Rochester, Minnesota, United States.

Sites can open and close during a study, so confirm with the team before travelling.

Ask the study team directly

From the trial registry

trial_locations

About This Trial

Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), a major global public health concern, is commonly associated with obesity, diabetes, and dyslipidemia. MASLD is currently the most common cause of chronic liver disease affecting about 80% of people with obesity, ranging from simple fat deposits in the liver to Metabolic Dysfunction-Associated Steatohepatitis (MASH), cellular injury, advanced fibrosis, cirrhosis, or hepatocellular carcinoma. Patients with MASH are also at risk for cardiovascular disease and mortality. There is no universally approved medication for MASH. Weight loss remains the cornerstone of MASH treatment. Patients meeting the inclusion and exclusion criteria and who give informed consent will be enrolled in the trial and undergo the baseline liver biopsy (if none available). Approximately 120 patients with MASH and liver fibrosis (F1-F4 in baseline liver biopsy) will be randomized in a 1:1 ratio to metabolic surgery or medical treatment (incretin-based therapies ± other medical therapies for MASH) and followed for 2 years at which time a repeat liver biopsy will be performed for the assessment of the primary end point.

Other Sites (1)

Mayo Clinic

Rochester, Minnesota, United States

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.

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Comparing Metabolic surgery with Incretin-Based Therapy for metabolic dysfunction-associated steatotic liver disease

Interventions

Canadian Sites (1)

Eligibility Criteria

Inclusion

Exclusion

In plain language

What is being tested — in plain terms

Common questions

About This Trial

Think this trial might be right for you?