Fibrosis Lessens After Metabolic Surgery

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Ali Aminian
Study ID
NCT06374875
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Metabolic surgery — PROCEDURE
    Patients receive either RYGB or SG. The surgical risk, differential impact of each procedure on body weight and other obesity-related diseases, presence of other medical and mental problems, patient's behavioral factors (e.g., postoperative compliance, active smoking), medications, and goals will be considered when the patient and local medical team make a shared decision about the most appropriate surgical procedure
  • Incretin-Based Therapy — DRUG
    Three incretin-based medications that have been approved for treatment of obesity including liraglutide, semaglutide, or tirzepatide will be used in the nonsurgical group. Any of these 3 medications (in the injection or oral from) based on availability in each country, access, and clinical indications can be used. If possible, patients will be placed on high-dose tirzepatide (Mounjaro or Zepbound 15 mg once weekly injection) or high-dose semaglutide (Wegovy 2.4 mg once weekly injection or Ozempic 2 mg once weekly injection). Other acceptable, less preferrable, options: liraglutide (Saxenda or Victoza), semaglutide tablet (Rybelsus), or lower dose of tirzepatide and semaglutide injections.

Study Details

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.

Key Dates

Start date
Jul 11, 2024
Status verified
Apr 2025
Primary completion
May 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Metabolic Surgery
    FLAMES will examine the class effect (not the specific procedure effect) of metabolic surgery. The study is not intended to compare Roux-en-Y Gastric Bypass (RYGB) vs Sleeve Gastrectomy (SG) head-to-head. RYGB and SG constitute one group as a metabolic surgery group. Assignment of RYGB or SG is not based on a randomized design. Each patient and surgical team will make a shared decision about the most appropriate surgical procedure.
  • Active Comparator: Incretin-Based Therapy
    Three incretin-based medications that have been approved for treatment of obesity including liraglutide, semaglutide, or tirzepatide will be used in the nonsurgical group. The FLAMES will examine the class effect (not the specific drug effect) of incretin-based therapies. The study is not intended to compare semaglutide vs tirzepatide vs liraglutide head-to-head.

Primary Outcome Measure

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

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Banner Health CenterPhoenixArizona85006
Farah Husain, MD
[email protected]
Indiana UniversityIndianapolisIndiana46202
Dimitrios Stefanidis, MD, PhD
[email protected]
Mayo ClinicRochesterMinnesota55905
Omar Ghanem, MD
[email protected]
Cleveland ClinicClevelandOhio44195
Ali Aminian, MD
[email protected]

Find similar trials in Phoenix, AZ

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Banner Health Center· Phoenix, AZIndiana University· Indianapolis, INMayo Clinic· Rochester, MNCleveland Clinic· Cleveland, OH

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