Sign in

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
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

Full criteria on ClinicalTrials.gov

Sites (34)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
West China Hospital,Sichuan University
Coordinator of this site? Confirm its status
ChengduChinaUnknown status
The First Affiliated Hospital of Henan University of Science and Technology
Coordinator of this site? Confirm its status
LuoyangChinaUnknown status
The Second Affiliated Hospital of Nanjing Medical University
Coordinator of this site? Confirm its status
NanjingChinaUnknown status
Shanghai Tenth People's Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Zhongshan Hospital Affiliated to Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Zentrum für Klinische Studien Bad Homburg
Coordinator of this site? Confirm its status
Bad HomburgGermanyUnknown status
Universitätsklinikum Erlangen
Coordinator of this site? Confirm its status
ErlangenGermanyUnknown status
Universitätsklinikum Freiburg
Coordinator of this site? Confirm its status
Freiburg im BreisgauGermanyUnknown status
Eugastro GmbH
Coordinator of this site? Confirm its status
LeipzigGermanyUnknown status
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Coordinator of this site? Confirm its status
MainzGermanyUnknown status
Hospital Universitario Virgen de la Arrixaca
Coordinator of this site? Confirm its status
El PalmarSpainUnknown status
Hospital Virgen del Camino
Coordinator of this site? Confirm its status
Sanlúcar de BarramedaSpainUnknown status
Ascires
Coordinator of this site? Confirm its status
ValenciaSpainUnknown status
Bradford Royal Infirmary
Coordinator of this site? Confirm its status
BradfordUnited KingdomUnknown status
St James's University Hospital
Coordinator of this site? Confirm its status
LeedsUnited KingdomUnknown status
Leicester Royal Infirmary
Coordinator of this site? Confirm its status
LeicesterUnited KingdomUnknown status
Guy's Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
St. Bartholomew's Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Derriford Hospital
Coordinator of this site? Confirm its status
PlymouthUnited KingdomUnknown status
Southwest Gastroenterology Associates, P.C.
Coordinator of this site? Confirm its status
AlbuquerqueUnited StatesUnknown status
Beth Israel Deaconess Medical Center
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Internal Medicine and Pediatric Associates of Bristol, PC
Coordinator of this site? Confirm its status
BristolUnited StatesUnknown status
Methodist Dallas Medical Center
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Duke University Medical Center
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status
University of Kansas Medical Center
Coordinator of this site? Confirm its status
Kansas CityUnited StatesUnknown status
Cedars-Sinai Medical Center
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Fomat Medical Research
Coordinator of this site? Confirm its status
OxnardUnited StatesUnknown status
California Liver Research Institute
Coordinator of this site? Confirm its status
PasadenaUnited StatesUnknown status
The Institute for Liver Health II DBA Arizona Clinical Trials
Coordinator of this site? Confirm its status
PeoriaUnited StatesUnknown status
Piedmont HealthCare, PA
Coordinator of this site? Confirm its status
StatesvilleUnited StatesUnknown status
Palmetto Clinical Research
Coordinator of this site? Confirm its status
SummervilleUnited StatesUnknown status
Kansas Medical Clinic PA
Coordinator of this site? Confirm its status
TopekaUnited StatesUnknown status
Covenant Metabolic Specialists, LLC - University Park
Coordinator of this site? Confirm its status
University ParkUnited StatesUnknown status
Interventional Cardiology Medical Group
Coordinator of this site? Confirm its status
West HillsUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.