NCT07850063Not 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)
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 25 Sept 2026
- Start date
- 2 Nov 2026
- Primary completion date
- 29 Apr 2029
- Lead sponsor
- Boehringer Ingelheim
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07850063
- EU CT number
- 2026-527091-88-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 600
- From 2 Nov 2026 to the primary completion date, 29 Apr 2029
- 34 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medications for obesity within 3 months before screening
Other illness
- Known or suspected hypersensitivity to the investigational medicinal product (IMP) or related products
- Established diagnosis of heart failure or a known history of heart failure
Other
- Impaired renal function at screening or requiring dialysis Further exclusion criteria apply.
Who the study is looking for
- 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
- 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
- Body mass index (BMI) ≥27 kg/m²
- Hepatic steatosis established by imaging (ultrasound or cross sectional), transient elastography, or liver biopsy Further inclusion criteria apply.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (34)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The First Affiliated Hospital of Henan University of Science and Technology Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
| The Second Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Shanghai Tenth People's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Zhongshan Hospital Affiliated to Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Zentrum für Klinische Studien Bad Homburg Coordinator of this site? Confirm its status | Bad Homburg | Germany | Unknown status |
| Universitätsklinikum Erlangen Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
| Universitätsklinikum Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Unknown status |
| Eugastro GmbH Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Hospital Universitario Virgen de la Arrixaca Coordinator of this site? Confirm its status | El Palmar | Spain | Unknown status |
| Hospital Virgen del Camino Coordinator of this site? Confirm its status | Sanlúcar de Barrameda | Spain | Unknown status |
| Ascires Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Bradford Royal Infirmary Coordinator of this site? Confirm its status | Bradford | United Kingdom | Unknown status |
| St James's University Hospital Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| Leicester Royal Infirmary Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| Guy's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| St. Bartholomew's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Derriford Hospital Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Southwest Gastroenterology Associates, P.C. Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Internal Medicine and Pediatric Associates of Bristol, PC Coordinator of this site? Confirm its status | Bristol | United States | Unknown status |
| Methodist Dallas Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Fomat Medical Research Coordinator of this site? Confirm its status | Oxnard | United States | Unknown status |
| California Liver Research Institute Coordinator of this site? Confirm its status | Pasadena | United States | Unknown status |
| The Institute for Liver Health II DBA Arizona Clinical Trials Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Piedmont HealthCare, PA Coordinator of this site? Confirm its status | Statesville | United States | Unknown status |
| Palmetto Clinical Research Coordinator of this site? Confirm its status | Summerville | United States | Unknown status |
| Kansas Medical Clinic PA Coordinator of this site? Confirm its status | Topeka | United States | Unknown status |
| Covenant Metabolic Specialists, LLC - University Park Coordinator of this site? Confirm its status | University Park | United States | Unknown status |
| Interventional Cardiology Medical Group Coordinator of this site? Confirm its status | West Hills | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.