- Fibrosis Lessens After Metabolic Surgery — Recruiting • Phase IV • Oncology • NCT06374875.
- What is being tested: The trial evaluates whether metabolic surgery (such as bariatric procedures) can reduce liver fibrosis in patients with metabolic dysfunction-associated steatotic liver disease (MASLD), addressing a gap in evidence for surgical intervention in advanced liver disease.
- Patient eligibility overview: The study targets individuals with MASLD who typically have concurrent obesity, type 2 diabetes, and/or dyslipidemia—representing the common comorbidity profile seen in metabolic liver disease populations.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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…
- 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: * 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 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%. 9. 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)…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.