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RecruitingPHASE4INTERVENTIONAL

Fibrosis Lessens After Metabolic Surgery

The FLAMES study investigates effective ways to treat a liver condition called MASH (Metabolic Dysfunction-Associated Steatohepatitis). MASH is a serious liver disease often connected to obesity and affects many people. Currently, there isn't one perfect medicine for MASH, and losing weight is key. This study wants to find out if metabolic (weight-loss) surgery is better than certain new medicines, called incretin-based therapies, at improving the liver damage caused by MASH. About 120 patients with MASH and liver scarring will be randomly split into two groups: one will have surgery, and the other will receive medication. Researchers will then check their liver health after two years.

At a glance

Status
Recruiting
Phase
PHASE4
Sponsor
Ali Aminian
Enrolment target
120
Start
11 Jul 2024
Estimated completion
31 Dec 2029

What is this study about?

Many people in the UK live with a condition called Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), which used to be known as non-alcoholic fatty liver disease (NAFLD). This condition means there's too much fat in the liver. For some, it can develop into a more serious problem called Metabolic Dysfunction-Associated Steatohepatitis, or MASH. MASH can lead to scarring (fibrosis) and serious liver damage if not managed.

Being overweight or having obesity, along with conditions like diabetes, are closely linked to MASLD and MASH. While lifestyle changes and weight loss are very important, there isn't a single medication that works for everyone with MASH. This study, called FLAMES (which stands for Fibrosis Lessens After Metabolic Surgery), aims to compare two different ways of treating MASH and its related liver scarring.

The study will look at whether metabolic (weight-loss) surgery is more effective than certain new medicines in a group called incretin-based therapies. Both treatments are known to help with weight loss and can improve health conditions linked to obesity. By comparing them directly, researchers hope to understand which approach leads to better healing and less scarring in the liver for people living with MASH.

Key takeaways

  • Compares weight-loss surgery to new medications for a serious liver disease called MASH.
  • Aims to see which treatment best reduces liver scarring.
  • Involves about 120 patients with MASH and obesity.
  • Requires a liver biopsy at the start and end of the two-year study.
  • Participation involves being randomly assigned to either surgery or medication.
  • The primary study site is in the USA, but it's an international trial.

Who may be eligible?

This study is looking for adults aged 18 to 75 who have both obesity and MASH (a type of liver disease with scarring). To be considered, you would generally need to be a candidate for weight-loss surgery and eligible for general anaesthesia. You'll also need to meet certain health checks, including having specific results from liver tests that suggest scarring.

There are also some specific health requirements related to your weight (your BMI should be between 35 and 70), and you should not have lost a lot of weight in the six months before joining. If you have type 2 diabetes, your condition needs to be stable. Women who could become pregnant would need to use reliable contraception during the study. The medical team will check all these details carefully to see if this study is suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you aged between 18 and 75?
  2. Do you have medically diagnosed MASH with liver scarring?
  3. Are you considered suitable for weight-loss surgery?
  4. Do you have a Body Mass Index (BMI) typically between 35 and 60?
  5. Are you able to commit to 2 years of follow-up including liver biopsies?
Answer every question to see your result.

What does participation involve?

If you decide to take part and are found eligible, you would first provide your informed consent, meaning you understand the study and agree to participate. You would then have a liver biopsy (a small sample taken from your liver) if you haven't had one recently that meets the study's needs. This helps the doctors understand your liver health at the start.

About 120 patients will be randomly split into two groups – like flipping a coin for either treatment. One group will receive metabolic (weight-loss) surgery, and the other will receive medical treatment using incretin-based therapies (medicines like semaglutide, tirzepatide, or liraglutide, which are given as injections or sometimes tablets, potentially with other medicines). Both groups will be followed closely for two years. At the end of these two years, you would have another liver biopsy to see how your liver health has changed. The main study site is in Cleveland, Ohio, USA, but it's a multi-centre international study.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from receiving cutting-edge treatments for your liver condition under close medical supervision. The knowledge gained from this study could also help countless others in the future. However, there are risks associated with any medical procedure or medication. Metabolic surgery carries risks like any major surgery, including infection, bleeding, or issues with anaesthesia. Incretin-based therapies can have side effects, which will be explained to you. You will have regular checks to monitor your health. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (22)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Banner Health Center
    Verified postcode
    Phoenix, United States· Not yet recruiting
  • Indiana University
    Verified postcode
    Indianapolis, United States· Not yet recruiting
  • Mayo Clinic
    Verified postcode
    Rochester, United States· Not yet recruiting
  • Cleveland Clinic
    Verified postcode
    Cleveland, United States· Recruiting
  • Hospital Alemão Oswaldo Cruz
    Verified postcode
    São Paulo, Brazil· Recruiting
  • McGill University
    Verified postcode
    Montreal, Canada· Not yet recruiting
  • Turku University Hospital
    Verified postcode
    Turku, Finland· Not yet recruiting
  • Sri Aurobindo Institute of Medical Sciences
    Verified postcode
    Indore, India· Not yet recruiting
  • The Digestive Health Institute
    Verified postcode
    Mumbai, India· Not yet recruiting
  • University College Dublin
    Verified postcode
    Dublin, Ireland· Not yet recruiting
  • Università Cattolica del Sacro Cuore
    Verified postcode
    Milan, Italy· Not yet recruiting
  • Sapienza Università di Roma
    Verified postcode
    Roma, Italy· Not yet recruiting

Common questions

What is MASH?

MASH stands for Metabolic Dysfunction-Associated Steatohepatitis. It's a serious liver condition where there's fat in the liver, along with inflammation and cell damage, which can lead to scarring.

What is metabolic surgery?

Metabolic surgery is a type of weight-loss surgery that can help people lose a significant amount of weight and improve obesity-related health conditions.

What are incretin-based therapies?

These are a group of medicines, often given as injections, that help control blood sugar and can also lead to weight loss, which can be beneficial for liver conditions.

Will I get to choose my treatment?

No, if you join the study, you will be randomly assigned to either the surgery group or the medication group, like drawing lots or flipping a coin.

How long will I be involved in the study?

If you participate, you will be followed for two years, with assessments at the beginning and the end of this period.

How to find out more

Awwab F Hammad, MD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Fibrosis Lessens After Metabolic Surgery…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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