Fibrosis Lessens After Metabolic Surgery

Recruiting now · Phase 4

Conditions studied: Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), Non-Alcoholic Fatty Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis (MASH), Liver Fibrosis, Obesity

In brief

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.

Key facts

Study ID

NCT06374875

Run by

The Cleveland Clinic

People needed

120

Starts

2024-07-11

Expected to finish

2029-12-31

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Entry into the study would require that the patient:
• Is a candidate for general anesthesia
• 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)
• 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
• 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
• 2 Exclusion Criteria
• Patients who meet the following criteria will be excluded from the study:
• 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)

Where it is running

• Hospital Alemão Oswaldo Cruz — São Paulo, Brazil (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States
• McGill University — Montreal, Canada
• Turku University Hospital — Turku, Finland
• Sri Aurobindo Institute of Medical Sciences — Indore, India
• The Digestive Health Institute — Mumbai, India
• University College Dublin — Dublin, Ireland
• Università Cattolica del Sacro Cuore — Milan, Italy
• Sapienza Università di Roma — Roma, Italy
• Kuwait University — Kuwait City, Kuwait
• Instituto Nacional de Ciencias Médicas y Nutrición Salvador — Mexico City, Mexico
• Hospital Clínic Barcelona — Barcelona, Spain
• Linköping University — Linköping, Sweden
• Örebro University — Örebro, Sweden
• Clarunis Universitäres — Basel, Switzerland
• Hôpitaux universitaires de Genève — Geneva, Switzerland
• Nuffield Health Bristol Hospital — Bristol, United Kingdom
• King's College Hospital — London, United Kingdom
• Banner Health Center — Phoenix, Arizona, United States
• Queen Mary University — London, United Kingdom
• Indiana University — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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