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Fibrosis Lessens After Metabolic Surgery
NCT06374875 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- PROCEDURE Metabolic surgery
- DRUG Incretin-Based Therapy
Study Locations (20)
Other
- Hospital Alemão Oswaldo Cruz — São Paulo
- McGill University — Montreal
- Turku University Hospital — Turku
- Sri Aurobindo Institute of Medical Sciences — Indore
- The Digestive Health Institute — Mumbai
- University College Dublin — Dublin
- Università Cattolica del Sacro Cuore — Milan
- Sapienza Università di Roma — Roma
- Kuwait University — Kuwait City
- Instituto Nacional de Ciencias Médicas y Nutrición Salvador — Mexico City
- Hospital Clínic Barcelona — Barcelona
- Linköping University — Linköping
- Örebro University — Örebro
- Clarunis Universitäres — Basel
- Hôpitaux universitaires de Genève — Geneva
- Nuffield Health Bristol Hospital — Bristol
Arizona
- Banner Health Center — Phoenix
Indiana
- Indiana University — Indianapolis
Minnesota
- Mayo Clinic — Rochester
Ohio
- Cleveland Clinic — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-07-11 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06374875
The ClinicalTrials.gov registry entry for NCT06374875 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ali Aminian, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions — of which Metabolic surgery is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06374875 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Other, Arizona, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06374875 about?
NCT06374875 is a clinical study titled "Fibrosis Lessens After Metabolic Surgery". 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 affe...
What is the current status of trial NCT06374875?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2024-07-11. Estimated completion is 2029-12-31.
What conditions does trial NCT06374875 study?
This clinical trial studies the following conditions: Obesity, Non-Alcoholic Fatty Liver Disease, Liver Fibrosis, Metabolic Dysfunction-Associated Steatohepatitis (MASH), Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06374875?
The interventions under investigation include: Metabolic surgery (PROCEDURE), Incretin-Based Therapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06374875?
This trial is sponsored by Ali Aminian, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06374875 being conducted?
This trial has 20 study locations across Arizona, Indiana, Minnesota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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