Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374875
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-16
Brief Title:
Fibrosis Lessens After Metabolic Surgery
Sponsor:
Ali Aminian
Organization:
The Cleveland Clinic
Study Overview
Official Title:
A Prospective Multicenter International Randomized Controlled Trial Comparing Surgical and Medical Therapies in the Treatment of Advanced Metabolic Dysfunction Associated Steatohepatitis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLAMES
Brief 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 11 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
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 11 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
Detailed Description:
FLAMES Fibrosis Lessens After Metabolic Surgery is a 2-arm randomized controlled pathologist-blinded multicenter study with 2 parallel groups of patients with MASH liver fibrosis and obesity who will either receive metabolic surgery or incretin-based therapies semaglutide injection or oral tirzepatide injection or liraglutide injection for 2 years to assess the effects of advanced surgical and medical therapies in liver histology in patients with obesity biopsy-proven MASH and liver fibrosis With genuine uncertainty in the expert medical community and literature over which treatment will result in a greater improvement in histopathological features of MASH and liver fibrosis the investigators aim to compare metabolic surgery and incretin-based therapies head-to-head
Adult patients with BMI between 35 - 60 kgm2 Fibrosis-4 FIB-4 index 13 liver stiffness measure LSM 12 kPa by vibration-controlled transient elastography VCTE using FibroScan or similar non-invasive tests who meet the contemporary eligibility criteria for metabolic surgery will be eligible for participation Patients meeting the inclusion and exclusion criteria and who give informed consent will be enrolled in the trial and undergo the baseline liver biopsy Approximately 120 patients with MASH and liver fibrosis F1-F4 in baseline liver biopsy will be randomized in a 11 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
The primary site of this multicenter international randomized controlled trial RCT is at the Cleveland Clinic main campus in Cleveland Ohio USA
Adult patients with BMI between 35 - 60 kgm2 Fibrosis-4 FIB-4 index 13 liver stiffness measure LSM 12 kPa by vibration-controlled transient elastography VCTE using FibroScan or similar non-invasive tests who meet the contemporary eligibility criteria for metabolic surgery will be eligible for participation Patients meeting the inclusion and exclusion criteria and who give informed consent will be enrolled in the trial and undergo the baseline liver biopsy Approximately 120 patients with MASH and liver fibrosis F1-F4 in baseline liver biopsy will be randomized in a 11 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
The primary site of this multicenter international randomized controlled trial RCT is at the Cleveland Clinic main campus in Cleveland Ohio USA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None