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Procedure

Metabolic Surgery for Non-Alcoholic Fatty Liver Disease (FLAMES Trial)

Phase 4

Recruiting

Led By Ali Aminian, MD

Research Sponsored by Ali Aminian

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is ≥18 and ≤70 years old

Is a candidate for general anesthesia

Must not have

Severe uncompensated cardiopulmonary disease leading to American Society of Anesthesiologists Class IV or V

Any other surgery requiring general anesthesia within 6 weeks prior to signing the consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, 2 years

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial aims to study a condition called Metabolic Dysfunction-Associated Steatohepatitis (MASH), which is a type of liver disease associated with obesity, diabetes, and high cholesterol. The

Who is the study for?

This trial is for individuals with MASLD, a liver condition linked to obesity and diabetes. It's open to those who have evidence of liver fibrosis (stages F1-F4). Participants must consent to a liver biopsy if they haven't had one recently.

What is being tested?

The study compares metabolic surgery against medical treatments using incretin-based therapies for MASH. About 120 patients will be randomly assigned to either the surgery or medication group and tracked over two years, including repeat liver biopsies.

What are the potential side effects?

Potential side effects from metabolic surgery can include nutritional deficiencies, gastrointestinal issues, and surgical complications. Incretin-based therapies may cause digestive problems like nausea or vomiting, pancreatitis risk increase, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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I am fit for general anesthesia.

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I qualify for weight loss surgery according to 2022 guidelines.

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My BMI is between 35 and 60.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe heart or lung disease.

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I have not had surgery under general anesthesia in the last 6 weeks.

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I have Crohn's disease.

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I have a history of chronic pancreatitis.

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I haven't taken medications like steroids or methotrexate that affect liver fat in the last 3 months.

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I was diagnosed with cancer, other than skin cancer, in the last 3 years.

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I have a concerning lump in my thyroid.

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I or my family have a history of medullary thyroid cancer or Multiple Endocrine Neoplasia type 2.

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I have a large hiatal hernia (more than 7 cm).

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I have a chronic liver disease.

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I am on a blood thinner like warfarin or DOACs.

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I often have severe low blood sugar without feeling it.

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I have had weight loss surgery before.

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I have had pancreatic cancer.

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I have had thyroid cancer in the past.

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I cannot safely have a liver biopsy.

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I have had complex surgery on my stomach or esophagus.

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My lung function is severely reduced, less than half of what's expected.

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My heart condition severely limits my physical activity.

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I have had fluid build-up in my abdomen or an infection in my abdomen.

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I haven't had a heart attack, stroke, or any major heart procedure in the last 6 months.

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I have a history of blood clots, including in my lungs or legs.

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My liver disease is moderately to severely advanced.

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I understand the risks, benefits, and what's required of me in the study.

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I was hospitalized for COVID-19 in the last 2 months.

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I am unable to understand and agree to the study's details on my own.

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I have had a solid organ transplant.

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My kidney function is very low or I am on dialysis.

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I am allergic to semaglutide, tirzepatide, liraglutide, or similar medications.

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I have had episodes of confusion due to liver problems.

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I have had bleeding from enlarged veins.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improvement of at least 1 fibrosis stage of the Kleiner fibrosis classification and no worsening of MASH in the repeat liver biopsy.

Secondary study objectives

Average Weight loss percentage

Disease-specific Quality of Life (QoL)

Fibrosis progression in the repeat liver biopsy

+2 more

Other study objectives

Achieved Weight-loss proportions

BMI change (kg/m^2)

Change in cardiovascular and diabetes medications

+15 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Metabolic SurgeryActive Control1 Intervention

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.

Group II: Incretin-Based TherapyActive Control1 Intervention

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.

0 / 35Eligibility criteria met