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NCT06374875 · ClinicalTrials.gov registry record · Phase 4

Fibrosis Lessens After Metabolic Surgery

A Phase 4 study of Obesity and Non-alcoholic Fatty Liver Disease, sponsored by Ali Aminian.

Recruiting
Registry status
Phase 4
Development phase
120
Enrollment target
20
Study locations

NCT06374875 is a Phase 4 study of Obesity and Non-alcoholic Fatty Liver Disease that is actively recruiting participants, run by Ali Aminian. The registered enrollment target is 120 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 5 states.

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The verdict

NCT06374875, a Phase 4 study of Obesity and Non-alcoholic Fatty Liver Disease, is actively recruiting participants, sponsored by Ali Aminian.

RECRUITING
Registry status
Phase 4
Development phase
120 participants
Enrollment target
20
Study locations

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

Obesity Non-alcoholic Fatty Liver Disease Liver Fibrosis Metabolic Dysfunction-Associated Steatohepatitis (MASH) Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

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

FieldValue
Enrollment Target 120 participants
Start Date 2024-07-11
Est. Completion 2029-12-31
Phase Phase 4

Sponsor

Ali Aminian

4 total trials

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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, categorized as Phase 4. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (85% lower). The listed sponsor is Ali Aminian, which has 4 total studies on file at ClinicalTrials.gov.

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.

NCT06374875 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Other, Arizona, Indiana.

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).

What interventions are being tested in trial NCT06374875?

The interventions under investigation include: Metabolic surgery (PROCEDURE), Incretin-Based Therapy (DRUG).

Who is sponsoring clinical trial NCT06374875?

This trial is sponsored by Ali Aminian, which has 4 total clinical trials registered on ClinicalTrials.gov.

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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