Fibrosis Lessens After Metabolic Surgery (NCT06374875) | Clinical Trial Compass
RecruitingPhase 4
Fibrosis Lessens After Metabolic Surgery
United States, Brazil, Canada120 participantsStarted 2024-07-11
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial involves two liver biopsies to measure fibrosis changes — given my current liver condition, how safe and appropriate would it be for me to undergo repeat liver biopsies as part of this study?
2The trial is studying whether metabolic surgery can improve liver fibrosis by at least one stage on the Kleiner scale — based on my current fibrosis stage, does my doctor think I'm at a point where surgery could realistically move the needle, or would other treatments make more sense first?
3Since this is a Phase 4 trial, the surgery itself is already approved, but what does my doctor know about the evidence specifically linking it to fibrosis improvement in people with my profile of MASLD or MASH?
4Metabolic surgery is a major procedure with its own recovery demands — how would the surgical requirements and follow-up schedule of this trial fit with my overall health, work, and day-to-day life?
5Are there non-surgical treatment options or other clinical trials for liver fibrosis that my doctor thinks I should weigh alongside this study before making a decision?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvement of at least 1 fibrosis stage of the Kleiner fibrosis classification and no worsening of MASH in the repeat liver biopsy.
. 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%.
Exclusion criteria
. Known history of other chronic liver diseases (drug induced, viral hepatitis, autoimmune, and genetic):
. 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.
. Type 1 diabetes or autoimmune diabetes
. Known cases of human immunodeficiency virus infection
. 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