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Fibrosis Lessens After Metabolic Surgery

Study acronym: FLAMES
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Notable Sponsor changed: Ali Aminian to The Cleveland Clinic
    • Collaborators shortened, about 3 words
    v6
  2. Minor Collaborators expanded, about 3 wordsv5
  3. Minor Eligibility criteria expanded, about 331 wordsv4
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 15, 2024 to Jul 11, 2024
    • Site details revised at 22 of 22 sites
    v3
  5. Notable Phase: Not applicable to Phase 4
    • Start date: May 1, 2024 to Jul 15, 2024
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT06374875
Lead Sponsor The Cleveland Clinic
Conditions
(from sponsor)
Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), Non-Alcoholic Fatty Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis (MASH), Liver Fibrosis, Obesity
Related terms Liver Cirrhosis, Non-alcoholic Fatty Liver Disease, Obesity
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov