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Not yet recruitingPHASE3INTERVENTIONAL

ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease

This research study, called ELEVATE-LIVER, is looking into a new medicine called survodutide. It's for adults (18 and over) who are overweight or obese and have a liver condition called metabolic dysfunction-associated steatotic liver disease (MASLD), which is a type of fatty liver disease. The main goal is to find out if survodutide can improve the health and function of the heart in these individuals. Participants will be randomly assigned to either receive weekly injections of survodutide or a 'dummy' injection (placebo) that contains no medicine. The study will last up to 1.5 years, involving regular clinic visits and phone calls to monitor health and heart changes.

At a glance

Status
Not yet recruiting
Phase
PHASE3
Sponsor
Boehringer Ingelheim
Enrolment target
600
Start
23 Oct 2026
Estimated completion
29 Apr 2029

What is this study about?

This study, called ELEVATE-LIVER, is investigating a new medicine named survodutide. It's for adults (aged 18 and over) who are overweight or obese and also have a common liver condition called metabolic dysfunction-associated steatotic liver disease (MASLD). MASLD is a type of fatty liver disease, meaning there's too much fat built up in the liver. People with MASLD, especially those who are overweight or obese, can sometimes experience changes in their heart's health.

The main purpose of this study is to explore if survodutide can help improve the structure and how well the heart works in people with MASLD. This is important because understanding how new medicines might benefit different aspects of health, like the heart, in people with existing conditions can lead to better care in the future. The study is in Phase 3, which means it's one of the final stages of testing a new medicine, involving a larger group of people to confirm its effects and safety.

By taking part, you would be helping researchers learn more about how survodutide affects the heart in people with MASLD. The information gathered from this study could be very valuable for developing new treatments and improving the long-term health of people living with these conditions.

Key takeaways

  • This study is testing a new medicine, survodutide, for fatty liver disease (MASLD).
  • It aims to see if survodutide can improve heart health in overweight or obese individuals.
  • Participants will receive weekly injections of either the medicine or a dummy treatment (placebo).
  • The study lasts up to 1.5 years and involves regular clinic visits and heart scans.
  • It's for adults aged 18 or older with a BMI of 27 or higher and confirmed MASLD.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. You should have a Body Mass Index (BMI) of 27 or higher, which is a measure that helps show if you are a healthy weight for your height. Importantly, you must also have been diagnosed with a type of fatty liver disease called metabolic dysfunction-associated steatotic liver disease (MASLD), which would have been confirmed through scans like an ultrasound or a liver biopsy.

There are also reasons why you might not be able to join. For example, if you've recently used other medicines for obesity within the last three months, or if you have a known allergy to the study medicine. People with a current diagnosis of heart failure or severely reduced kidney function are also not able to take part. The study team will review all your health information carefully to ensure it's safe for you to participate.

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 18 years old or older?
  2. Do you have a Body Mass Index (BMI) of 27 or more?
  3. Have you been diagnosed with a type of fatty liver disease called MASLD?
  4. Have you avoided other obesity medicines in the last 3 months?
  5. Do you *not* have current heart failure or severe kidney problems?
Answer every question to see your result.

What does participation involve?

If you join this study, you will be in it for up to 1.5 years. You will be randomly put into one of two groups: one group will receive the study medicine, survodutide, and the other will receive a 'dummy' injection (placebo) which looks the same but contains no medicine. Neither you nor your study doctor will know which injection you are getting, to keep the results fair.

Both survodutide and the placebo are given as an injection under the skin of your tummy once a week. Your first injection will be given at the study clinic. After that, you'll usually give yourself the injections at home using a pre-filled syringe.

During the study, you'll visit the study clinic about 14 times and have about 4 phone calls with the study team. At some of your visits, doctors will use special ultrasound scans to check your heart's health. The study team will also regularly check your general health and note any changes or health problems you might experience.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. A potential benefit of this study is that the study medicine, survodutide, might help improve your heart's health if you are in the active treatment group. You will also receive careful health monitoring throughout the study. However, there's no guarantee you'll receive the active medicine or that it will benefit you. Potential risks could include side effects from the injections, or discomfort from clinic visits and procedures like blood tests. You will be given a full list of known side effects. Your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (25)

  • The Institute for Liver Health II DBA Arizona Clinical Trials
    Verified postcode
    Peoria, United States
  • Cedars-Sinai Medical Center
    Verified postcode
    Los Angeles, United States
  • Fomat Medical Research
    Verified postcode
    Oxnard, United States
  • California Liver Research Institute
    Verified postcode
    Pasadena, United States
  • Covenant Metabolic Specialists, LLC - University Park
    Verified postcode
    University Park, United States
  • University of Kansas Medical Center
    Verified postcode
    Kansas City, United States
  • Kansas Medical Clinic PA
    Verified postcode
    Topeka, United States
  • Beth Israel Deaconess Medical Center
    Verified postcode
    Boston, United States
  • Southwest Gastroenterology Associates, P.C.
    Verified postcode
    Albuquerque, United States
  • Duke University Medical Center
    Verified postcode
    Durham, United States
  • Palmetto Clinical Research
    Verified postcode
    Summerville, United States
  • Internal Medicine and Pediatric Associates of Bristol, PC
    Verified postcode
    Bristol, United States

Common questions

What is 'fatty liver disease'?

Fatty liver disease means there's too much fat stored in your liver cells. In this study, they're looking at a specific type called MASLD, which is linked to being overweight or obese.

What is 'survodutide'?

Survodutide is a new medicine being tested. Researchers want to see if it can help improve heart health in people who are overweight or obese and have fatty liver disease.

What is a 'placebo'?

A placebo is like a dummy treatment. It looks exactly like the study medicine (survodutide) but doesn't contain any active ingredients. It helps researchers fairly compare the effects of the real medicine.

Will I know if I'm getting the medicine or the placebo?

No, neither you nor your study doctor will know whether you are receiving survodutide or the placebo. This helps make sure the study results are unbiased and accurate.

How is the medicine given?

The medicine or placebo is given as an injection under the skin of your tummy once a week. After the first injection at the clinic, you'll usually give yourself the rest at home using a pre-filled syringe.

How to find out more

Boehringer Ingelheim

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 "ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Imp…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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