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Study identifier: NCT06374875 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Fibrosis Lessens After Metabolic Surgery

Condition: Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) · Non-Alcoholic Fatty Liver Disease · Metabolic Dysfunction-Associated Steatohepatitis (MASH)  ·  Sponsor: Ali Aminian

PhasePhase 4
Planned participants120
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersYes

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.

This description comes directly from the study's public registry record.

Talk to the study team

Awwab F Hammad, MD  ·  +1 216 444 5022  ·  hammada4@ccf.org

Chytaine Hall  ·  216-445-3983  ·  hallc1@ccf.org

Always discuss trial participation with your own doctor first.

Locations (22)

Banner Health CenterPhoenix, Arizona, United StatesNot Yet Recruiting
Indiana UniversityIndianapolis, Indiana, United StatesNot Yet Recruiting
Mayo ClinicRochester, Minnesota, United StatesNot Yet Recruiting
Cleveland ClinicCleveland, Ohio, United StatesRecruiting
Hospital Alemão Oswaldo CruzSão Paulo, BrazilRecruiting
McGill UniversityMontreal, CanadaNot Yet Recruiting
Turku University HospitalTurku, FinlandNot Yet Recruiting
Sri Aurobindo Institute of Medical SciencesIndore, IndiaNot Yet Recruiting
The Digestive Health InstituteMumbai, IndiaNot Yet Recruiting
University College DublinDublin, IrelandNot Yet Recruiting
Università Cattolica del Sacro CuoreMilan, ItalyNot Yet Recruiting
Sapienza Università di RomaRoma, ItalyNot Yet Recruiting

+ 10 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06374875