RecruitingPhase 4NCT06374875

Fibrosis Lessens After Metabolic Surgery

A Prospective Multicenter International Randomized Controlled Trial Comparing Surgical and Medical Therapies in the Treatment of Advanced Metabolic Dysfunction Associated Steatohepatitis


Sponsor

Ali Aminian

Enrollment

120 participants

Start Date

Jul 11, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Incretin-Based Therapy and a procedure called Metabolic surgery for people with liver fibrosis, metabolic dysfunction-associated steatohepatitis (mash), and other related conditions. The study is currently recruiting participants at 22 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREMetabolic surgery

Patients receive either RYGB or SG. The surgical risk, differential impact of each procedure on body weight and other obesity-related diseases, presence of other medical and mental problems, patient's behavioral factors (e.g., postoperative compliance, active smoking), medications, and goals will be considered when the patient and local medical team make a shared decision about the most appropriate surgical procedure

DRUGIncretin-Based Therapy

Three incretin-based medications that have been approved for treatment of obesity including liraglutide, semaglutide, or tirzepatide will be used in the nonsurgical group. Any of these 3 medications (in the injection or oral from) based on availability in each country, access, and clinical indications can be used. If possible, patients will be placed on high-dose tirzepatide (Mounjaro or Zepbound 15 mg once weekly injection) or high-dose semaglutide (Wegovy 2.4 mg once weekly injection or Ozempic 2 mg once weekly injection). Other acceptable, less preferrable, options: liraglutide (Saxenda or Victoza), semaglutide tablet (Rybelsus), or lower dose of tirzepatide and semaglutide injections.


Locations(22)

Banner Health Center

Phoenix, Arizona, United States

Indiana University

Indianapolis, Indiana, United States

Mayo Clinic

Rochester, Minnesota, United States

Cleveland Clinic

Cleveland, Ohio, United States

Hospital Alemão Oswaldo Cruz

São Paulo, Brazil

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

Queen Mary University

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06374875


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