Fibrosis Lessens After Metabolic Surgery
Eligible age
18–75 yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
Yes
See if you qualify for this study
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About this study
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.
Sponsor: Ali Aminian
You may qualify if…
- ✓ Entry into the study would require that the patient:
- ✓ 1. Is a candidate for general anesthesia
- ✓ 2. Is eligible for metabolic surgery (RYGB or SG) based on the ASMBS/IFSO 2022 guidelines
- ✓ 3. Has insurance coverage for metabolic surgery (the requirements may vary in each country)
- ✓ 4. Is ≥18 and ≤75 years old at the time of signing the informed consent
- ✓ 5. Has a BMI ≥35 and ≤70 kg/m2 at the time of first study visit
- ✓ 6. FIB-4 ≥ 1.3
- ✓ 7. At least one of the following 5 criteria suggesting presence of advanced fibrosis:
Where it's recruiting
Source: ClinicalTrials.gov · NCT06374875 · last updated 2025-08-22