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Not yet recruitingPhase 3

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

A Multi-centre, Randomised, Double-blind, Placebo-controlled, Phase IIIb Trial to Evaluate the Effect of Survodutide on Cardiac Structure and Function of Participants With Overweight or Obesity and Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD); (ELEVATE-LIVER)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections, Phone or video check-ins, Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "One group gets survodutide as an injection under the skin of the abdomen once a week."
  • "The other group gets placebo as an injection once a week."
  • "The first injection is given at the study site."
  • "Later injections are usually given by the participants themselves at home using pre-filled syringes."
  • "During this time, they visit the study site about 14 times and have about 4 phone calls with the study staff."
  • "At some of the visits, doctors use ultrasound scans to check the heart."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether survodutide helps improve the heart’s shape and how well it works. It is for adults with overweight or obesity, a type of fatty liver disease called MASLD, and certain heart and blood vessel risk factors. Participants get a weekly shot of survodutide or a placebo, a shot with no medicine.

This study is for adults aged 18 years and older who have a type of fatty liver disease called metabolic dysfunction-associated steatotic liver disease (MASLD). People can take part if their body mass index (BMI) is 27 kg/m² or higher, and they have certain heart and blood vessel risk factors. The purpose of this study is to find out how a medicine called survodutide affects heart structure and function in people with MASLD. Participants are put into 2 groups randomly, which means by chance. One group gets survodutide as an injection under the skin of the abdomen once a week. The other group gets placebo as an injection once a week. Placebo looks like survodutide but does not contain any medicine. The first injection is given at the study site. Later injections are usually given by the participants themselves at home using pre-filled syringes. Participants and doctors do not know who is getting survodutide or placebo. Participants are in the study for up to 1.5 years. During this time, they visit the study site about 14 times and have about 4 phone calls with the study staff. At some of the visits, doctors use ultrasound scans to check the heart. The results are compared between the 2 groups to see if survodutide helps improve the health of the heart. The study staff also regularly check participants' health and take note of any health problems.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old and meet the legal age to agree to join in your country.
  • Sign and date a form agreeing to join before entering the study.
  • Have a body mass index (BMI), a measure based on height and weight, of 27 or higher.
  • Have fat in the liver shown by a scan or a liver tissue sample.
  • Have certain heart and blood vessel risk factors.
  • Other rules for joining also apply.

Who can't join

  • Used weight-loss medicine within 3 months before screening.
  • Have a known or suspected allergy to the study medicine or related products.
  • Have heart failure now or have had it before. This means the heart does not pump blood as well as it should.
  • Have kidneys that do not work well at screening, or need dialysis, a treatment that filters the blood.
  • Other rules that may prevent joining also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key inclusion criteria: 1. Age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is \>18 years 2. Signed and dated written informed consent in accordance with international council for harmonisation - good clinical practice (ICH-GCP) and local legislation prior to admission to the trial 3. Body mass index (BMI) ≥27 kg/m² 4. Hepatic steatosis established by imaging (ultrasound or cross sectional), transient elastography, or liver biopsy Further inclusion criteria apply. Key exclusion criteria: 1. Medications for obesity within 3 months before screening 2. Known or suspected hypersensitivity to the investigational medicinal product (IMP) or related products 3. Established diagnosis of heart failure or a known history of heart failure 4. Impaired renal function at screening or requiring dialysis Further exclusion criteria apply.

Study sites (13)

AZ

CA

FL

KS

MA

NC

NM

SC

TN

TX