Fibrosis Lessens After Metabolic Surgery (FLAMES)

August 18, 2025 updated by: Ali Aminian

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 kg/m^2, Fibrosis-4 (FIB-4) index ≥ 1.3, 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 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.

The primary site of this multicenter, international, randomized controlled trial (RCT) is at the Cleveland Clinic main campus in Cleveland, Ohio, USA.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Chytaine Hall
  • Phone Number: 216-445-3983
  • Email: hallc1@ccf.org

Study Contact Backup

  • Name: Awwab F Hammad, MD
  • Phone Number: +1 216 444 5022
  • Email: hammada4@ccf.org

Study Locations

  • Brazil
  • Canada
      • Montréal, Canada
  • Finland
      • Turku, Finland
  • India
      • Indore, India
        • Not yet recruiting
        • Sri Aurobindo Institute of Medical Sciences
        • Contact:
      • Mumbai, India
        • Not yet recruiting
        • The Digestive Health Institute
        • Contact:
  • Ireland
      • Dublin, Ireland
        • Not yet recruiting
        • University College Dublin
        • Contact:
  • Italy
  • Kuwait
      • Kuwait, Kuwait
        • Not yet recruiting
        • Kuwait University
        • Contact:
  • Mexico
      • Mexico City, Mexico
        • Not yet recruiting
        • Instituto Nacional de Ciencias Médicas y Nutrición Salvador
        • Contact:
          • Mauricio Sierra, MD
  • Spain
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital Clinic Barcelona
        • Contact:
  • Sweden
  • Switzerland
      • Basel, Switzerland
      • Geneva, Switzerland
        • Not yet recruiting
        • Hôpitaux Universitaires de Genève
        • Contact:
  • United Kingdom
      • Bristol, United Kingdom
      • London, United Kingdom
      • London, United Kingdom
        • Not yet recruiting
        • Queen Mary University
        • Contact:
  • United States
    • Arizona
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

Entry into the study would require that the patient:

  1. Is a candidate for general anesthesia
  2. Is eligible for metabolic surgery (RYGB or SG) based on the ASMBS/IFSO 2022 guidelines
  3. Has insurance coverage for metabolic surgery (the requirements may vary in each country)
  4. Is ≥18 and ≤75 years old at the time of signing the informed consent
  5. Has a BMI ≥35 and ≤70 kg/m2 at the time of first study visit
  6. FIB-4 ≥ 1.3

  7. At least one of the following 5 criteria suggesting presence of advanced fibrosis:

    • LSM ≥ 12 kPa by VCTE using FibroScan®
    • LSM ≥ 12 kPa by SWE
    • LSM ≥ 1.7 m/s by ARFI
    • LSM ≥ 3.63 kPa MRE
    • ELF score ≥ 9.8
  8. Patients with and without T2DM are eligible for the study. Patients with T2DM should have been on a stable dose of anti-diabetic medication (including insulin but not semaglutide or tirzepatide or liraglutide) for at least 3 months prior to entry, with glycated hemoglobin (HbA1c) ≤12%.

  9. Self-reported stable weight in 6 months before the first study visit (no weight loss >10% within 6 months prior to the first study visit)

    a. In patients with a historical noninvasive tests or liver biopsy, weight loss of no more than 10% is allowed from 6 months prior to the historical tests until the first study visit

  10. Has the ability and willingness to participate in the study, provide informed consent, and agree to any of the arms involved in the study
  11. Can understand the options and comply with the requirements of each arm, including one liver biopsy performed during the screening period (if no adequate biopsy within 12 months before screening is available) and one liver biopsy after 2-years
  12. Has a negative urine pregnancy test at the first and at the randomization visits for women of childbearing potential.
  13. Women of childbearing age must agree to use reliable method of contraception for 2 years

8.2 Exclusion Criteria

Patients who meet the following criteria will be excluded from the study:

  1. Known history of other chronic liver diseases (drug induced, viral hepatitis, autoimmune, and genetic):

    • Hepatitis B as detected by presence of hepatitis B surface antigen (HBsAg)
    • Hepatitis C as detected by presence of hepatitis C virus (HCV) RNA (in case the screening test for hepatitis C is positive, the confirmative test is decisive)
    • Autoimmune liver disease as diagnosed by antibodies or compatible liver histology
    • Primary biliary cirrhosis as defined by the presence of at least 2 criteria (elevated alkaline phosphatase, presence of anti-mitochondrial antibody, and histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts)
    • Primary sclerosing cholangitis
    • Wilson's disease as diagnosed by low ceruloplasmin or compatible liver histology
    • Alpha-1-antitrypsin deficiency as diagnosed by alpha1-antitrypsin level or liver histology
    • Hemochromatosis as diagnosed by HFE mutations (C282Y, H63D), ferritin and transferrin saturation levels, or presence of 3+ or 4+ stainable iron on liver biopsy
    • Drug-induced liver disease diagnosed by medical history
    • Known bile duct obstruction
    • Suspected or proven liver cancer
  2. Weight change >10% within 6 months prior to the first study visit or prior to the historical liver biopsy

  3. Treatment with semaglutide, tirzepatide, or liraglutide (for obesity or for T2DM) <90 days before the first study visit.

    • However, patients are allowed to participate if they have been on a low dose (or are on older generation GLP-1 agonists) and have lost less than 10% of their body weight since starting the medication.

  4. Type 1 diabetes or autoimmune diabetes
  5. Known cases of human immunodeficiency virus infection

  6. Prior bariatric and metabolic surgery of any kind

    • Reversed procedures such as gastric band or intragastric balloon that have been removed at least 3 months prior to the first study visit are allowed.

  7. Prior complex foregut surgery including any esophageal and gastric surgeries, anti-reflux procedures, biliary diversion, and complex trauma surgery
  8. Any surgery requiring general anesthesia within 1 month prior to signing the consent
  9. History of solid organ transplant
  10. Severe pulmonary disease defined as FEV1 < 50% of predicted value
  11. Significant cardiac or atherosclerotic disease (planned to undergo cardiac, coronary, carotid, or peripheral artery revascularization procedures in the next 12 months)
  12. Severe uncompensated cardiopulmonary disease leading to American Society of Anesthesiologists Class IV or V
  13. Classified as New York Heart Association Class IV
  14. Left ventricular ejection fraction <25% at the time of screening
  15. Myocardial infarction, unstable angina, stroke, heart surgery, coronary stent placement in the past 6 months
  16. Chronic renal insufficiency with eGFR below 30 mL/min/1.73 m2, or being on dialysis
  17. Presence of large hiatal hernia (>7 cm)
  18. Presence of Crohn's disease
  19. Psychiatric disorders including (but not limited to) dementia, active psychosis, severe depression requiring 3 or more medications, history of suicide attempts, active alcohol, or substance abuse within the previous 12 months that in the opinion of the investigators could disqualify the patient from metabolic surgery
  20. Pregnancy, the intention of becoming pregnant, or not using adequate contraceptive measures
  21. Breastfeeding
  22. Diagnosis of malignancy within the preceding 3 years (except squamous cell and basal cell cancer of the skin)
  23. Anemia defined as hemoglobin less than 9 g/dL
  24. On therapeutic dose of anticoagulants such as warfarin or direct oral anticoagulants (DOACs)
  25. Known history of clotting disorders, including pulmonary embolus and deep vein thrombosis
  26. Clinical judgment that life expectancy is less than 3 years
  27. Use of investigational therapy within 3 months prior to signing the consent
  28. History of pancreatic carcinoma
  29. Acute pancreatitis < 180 days before screening
  30. History or presence of chronic pancreatitis
  31. Presence of concerning thyroid nodule

  32. Uncontrolled thyroid disease: thyroid stimulating hormone (TSH) > 6.0 mIU/L or < 0.1 mIU/L before the first study visit

    • Patients receiving treatment for hypothyroidism can be included if their thyroid hormone replacement dose has been stable for at least 3 months.
    • Patients whose TSH is outside the rang but they have normal levels of thyroid hormones can be included.
  33. A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

  34. Evidence or history of ascites or spontaneous bacterial peritonitis that require(d) treatment

    • Trace ascites identified only by an abdominal imaging without other evidence of clinically significant portal hypertension and esophageal varices is not an exclusion criterion.

  35. Evidence or history of hepatic encephalopathy
  36. Evidence or history of variceal bleeding
  37. Evidence or history of portosplenic vein thrombosis

  38. Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to the first study visit.

    • Defined as more than 14 units/week for females (>1 drink per day) and more than 21 units/week for males (>2 drinks per day) on average, where one unit of alcohol is equivalent to a 12-oz beer, 4-ounce glass of wine, or 1-ounce shot of hard liquor.

  39. Treatment with medications (for more than 14 consecutive days) with known effect on liver steatosis (e.g., treatment with systemic corticosteroids [oral or intravenous], methotrexate, tamoxifen, valproic acid, amiodarone, or tetracycline) in the 3 months prior to the first study visit (or historical liver biopsy).
  40. ALT or AST or Alkaline phosphatase >200 U/L
  41. Recurrent major hypoglycemia or hypoglycemic unawareness
  42. Inability to safely obtain a liver biopsy
  43. Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study
  44. Unable to understand the risks, benefits, and compliance requirements of study
  45. Lack capacity to give informed consent
  46. Plans to move outside the primary location of study (country) within the next 24 months
  47. Known or suspected allergy to semaglutide, tirzepatide, liraglutide, excipients, or related products
  48. Previous participation in this trial and got randomized to one of the study groups but did not proceed.
  49. Hospitalization due to COVID-19 within 2 months prior to screening.
  50. Platelet count <80,000
  51. International Normalized Ratio (INR) >1.7
  52. Child-Pugh score B or C
  53. MELD score ≥15
  54. Upper endoscopy showing gastroesophageal varices
  55. Upper endoscopy showing more than mild portal hypertensive gastropathy

  56. Liver vascular ultrasound (duplex ultrasonography) showing significant portal hypertension characterized by dilated portal vein (>13 mm), biphasic or reverse flow in the portal vein, enlarged paraumbilical veins, splenorenal collaterals, or dilated left and short gastric veins.

    Note: Negative findings on upper endoscopy and liver duplex ultrasound (done within one year of the first study visit for both tests) are necessary to establish eligibility for the FLAMES.

    • Ruling out clinically significant portal hypertension is particularly important in patients with a liver stiffness ≥20 kPa or with a platelet count <150,000 per μL or with a (historical) liver biopsy showing cirrhosis.

    • A subset of patients without having upper endoscopy and liver duplex ultrasound can be eligible for enrollment if their:

      • liver stiffness (by transient elastography using FibroScan®) is between 12 and 15 kPa and their platelet count is >150,000 per μL, or
      • a (historical) liver biopsy showing absence of cirrhosis, or
      • a (historical) HVPG < 5 mmHg

  57. Cross-sectional abdominal imaging (if available historically) indicating presence of large portosystemic collaterals or ascites

    • Splenomegaly alone (in the absence of other radiological and laboratory findings) is not considered to be a sign of clinically significant portal hypertension and is not an exclusion criterion.

  58. HVPG ≥ 12 mmHg (if available historically or if measured at the time of de novo liver biopsy)

  59. Liver biopsy characteristics:

    • F0 in de novo biopsy; Enrollment cap of 20% for F1 in de novo biopsy.
    • F0 and F1 in historical liver biopsy
    • Absence of all three components of MASH (steatosis, hepatocyte ballooning, and lobular inflammation) in patients with F1, F2, and F3
    • Absence of steatosis (<5%) in patients with F4
    • Diagnosis other than MASH

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: Metabolic surgery
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
Other Names:
  • Bariatric surgery
  • Roux-en-Y Gastric Bypass (RYGB)
  • Sleeve Gastrectomy (SG)
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.
Drug: 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. 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.
Other Names:
  • Glucagon-like Peptide-1 Receptor Agonist

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Development of hepatic decompensation events including ascites (requiring treatment including diuretics), spontaneous bacterial peritonitis, hepatic encephalopathy (requiring treatment or hospitalization), or bleeding esophageal varices, and all-cause mortality will be counted as a treatment failure with no need for repeating liver biopsy.
Through study completion, 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MASH resolution in the repeat liver biopsy
Time Frame: Through study completion, 2 years
MASH resolution defined as no hepatocyte ballooning (score of 0 according to the NASH CRN criteria), no more than mild residual inflammatory cells (score of 0 or 1), without worsening of liver fibrosis stage in the repeat liver biopsy
Through study completion, 2 years
MASH resolution and fibrosis improvement in the repeat liver biopsy
Time Frame: Through study completion, 2 years
Presence of both MASH resolution and fibrosis improvement in the repeat liver biopsy
Through study completion, 2 years
Fibrosis progression in the repeat liver biopsy
Time Frame: Through study completion, 2 years
Defined as worsening of at least 1 fibrosis stage of the Kleiner fibrosis classification in the repeat liver biopsy among patients who did not have F4 in the baseline liver biopsy
Through study completion, 2 years
Average Weight loss percentage
Time Frame: Through study completion, 2 years
Mean percentage weight loss from baseline
Through study completion, 2 years
Disease-specific Quality of Life (QoL)
Time Frame: Through study completion, 2 years
Change from baseline in score of a disease-specific QoL instrument: Chronic Liver Disease Questionnaire (CLDQ) for NASH (CLDQ-NASH). This instrument collects data on 36 items grouped into 6 domains: abdominal symptoms, activity/energy, emotional health, fatigue, systemic symptoms, and worry. In all domains, greater scores (between 1-7) reflect better health, and the average of the domain scores yields the total CLDQ-NASH score. Research coordinator completes the survey with the patient.
Through study completion, 2 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MASLD-related histopathologic end points
Time Frame: Through study completion, 2 years
  • Improvement of at least 1 fibrosis stage of the Kleiner fibrosis classification, regardless of changes in MASH severity
  • Progression to cirrhosis (F4) in repeat liver biopsy among patients who did not have F4 in the baseline liver biopsy
  • Mean and change from baseline in NAFLD Activity Score
  • Reduction in NAFLD Activity Score by at least 1, 2, or 3 points
  • Histopathological changes in severity of steatosis, inflammation, hepatocyte ballooning, and fibrosis
  • Histopathological changes in modified Ishak fibrosis score
  • Histopathological changes in features of regression (Beijing classification, P-I-R fibrosis quality)
Through study completion, 2 years
MASLD-related laboratory end points
Time Frame: Through study completion, 2 years
Mean and change from baseline in ALT, AST, Alkaline phosphatase, bilirubin, platelet count, eGFR, and FIB-4
Through study completion, 2 years
MASLD-related liver scan end points
Time Frame: Through study completion, 2 years
Change in liver stiffness in elastography (based on the same device that was used at baseline)
Through study completion, 2 years
MASLD-related clinical end points
Time Frame: Through study completion, 2 years
Development of adverse clinical outcomes including development of ascites or hydrothorax (requiring treatment including diuretics), hepatic encephalopathy (requiring treatment or hospitalization), bleeding esophageal varices, liver-related mortality, and all-cause mortality as a composite and individual end points
Through study completion, 2 years
Achieved Weight-loss proportions
Time Frame: Through study completion, 2 years
Proportion of participants achieving ≥ 5%, ≥ 10%, ≥ 15%, ≥ 20%, ≥ 25%, ≥ 30%, ≥ 35% weight loss from baseline (yes/no) in each two groups
Through study completion, 2 years
Weight change (kg)
Time Frame: Through study completion, 2 years
Absolute change in weight (kg)
Through study completion, 2 years
BMI change (kg/m^2)
Time Frame: Through study completion, 2 years
Absolute change in BMI (kg/m^2)
Through study completion, 2 years
Excess weight loss, %
Time Frame: Through study completion, 2 years
Calculated by dividing the difference between initial BMI and final BMI by the difference between initial BMI and a target BMI of 25
Through study completion, 2 years
Change in waist circumference, cm
Time Frame: Through study completion, 2 years
Change in circumferential measurement above the level of the iliac crests
Through study completion, 2 years
Systolic blood pressure trends, mmHg
Time Frame: Through study completion, 2 years
Mean and change in systolic blood pressure, mmHg
Through study completion, 2 years
Mean and change from baseline in lipid panel, mg/dl
Time Frame: Through study completion, 2 years
Mean and change from baseline in total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides
Through study completion, 2 years
Changes in glucose hemostasis markers
Time Frame: Through study completion, 2 years
Mean and change from baseline in blood glucose, HbA1c, and fasting homoeostasis model of assessment of insulin resistance (HOMA-IR) in patients with T2DM
Through study completion, 2 years
Percentage of patients with T2DM meeting predefined HbA1c targets
Time Frame: Through study completion, 2 years
  • HbA1c <6.5% (without diabetes medications)
  • HbA1c <7% (irrespective of taking diabetes medications or not)
Through study completion, 2 years
Changes in inflammatory markers, CRP mg/L
Time Frame: Through study completion, 2 years
Mean and change from baseline in C-Reactive Protein (CRP)
Through study completion, 2 years
Change in cardiovascular and diabetes medications
Time Frame: Through study completion, 2 years
Change in number of cardiovascular and diabetes medications prescribed
Through study completion, 2 years
SF-Bari Score
Time Frame: Through study completion, 2 years
Swiss-Finnish Bariatric Metabolic Outcome Score (SF-BARI Score) which combines four areas of clinical interest in obesity treatment (weight loss, outcomes of four major obesity-related comorbidities, complications, and QoL) in one score. The SF-BARI Score range is from -100 to 200 and the SF-BARI Score QOL is from -130 to 230. The total score ranges from suboptimal (scores below 35) to excellent (scores equal or greater than 135). Research coordinator completes the survey with the patient.
Through study completion, 2 years
Quality of life end points
Time Frame: Through study completion, 2 years
Change from baseline in score of The 36-Item Short Form Health Survey (SF-36) (physical and mental components). Each item is given a score ranging from 0-100. Lower scores indicating poor outcomes. Final score is an average of all the items that were answered. Unanswered questions are not included in the final average. Research coordinator completes the survey with the patient.
Through study completion, 2 years
Safety end points
Time Frame: Through study completion, 2 years
Complications specifically related to MASH disease, as well as complications of liver biopsy, metabolic surgery, liraglutide, semaglutide, tirzepatide, and other medications will be recorded and evaluated.
Through study completion, 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ali Aminian

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sobia Laique, MD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ali Aminian, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24-213

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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