Study S001561

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

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT06374875
Acronym: FLAMES
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: SINGLE
Status: RECRUITING
Enrollment: 120
Start: 2024-07-11
Primary completion: 2029-05-31
Lead sponsor: The Cleveland Clinic
Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD); Non-Alcoholic Fatty Liver Disease; Metabolic Dysfunction-Associated Steatohepatitis (MASH); Liver Fibrosis; Obesity
Interventions: PROCEDURE:Metabolic surgery; DRUG:Incretin-Based Therapy
Results posted: FALSE
Individual participant data sharing: YES

Registered primary outcomes

Improvement of at least 1 fibrosis stage of the Kleiner fibrosis classification and no worsening of MASH in the repeat liver biopsy. [Through study completion, 2 years]

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