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

NCTNCT07850063Other id1404-0128Other id1111-1339-5364Other id2026-527091-88-00

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Overview

Status: Not yet recruiting
Phase: Phase 3
Enrollment: 600 participants (estimated)
Sponsor: Boehringer Ingelheim · Industry
Design: Randomized · Quadruple masking
Countries: 5 countries
United States, China, Germany, Spain, United Kingdom
Start: 23 Oct 2026 (estimated)
Primary completion: 29 Apr 2029 (estimated)
Completion: 29 Apr 2029 (estimated)
First posted: 30 Sept 2026
Last update posted: 30 Sept 2026
Conditions: Obesity · Metabolic Dysfunction-associated Steatotic Liver Disease

Timeline

1 trial · 1 not yet recruiting

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20262027202820292030

Ph 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
NCT07850063
est. 23 Oct 2026 to est. 29 Apr 2029

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

SurvodutideCombination product
Placebo matching survodutideCombination product

Arms2

Experimental
Survodutide arm
Placebo comparator
Placebo arm

Primary outcomes1

Outcomes the sponsor listed as primary.

Composite average Z-score (dimensionless) at Week 76 of cardiac structural and functional parameters
Time frame · At week 76

Secondary outcomes(8)

Relative change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from baseline to 76 weeks (%)
Time frame · At baseline and up to 76 weeks
Relative change in alanine aminotransferase (ALT) from baseline to 76 weeks (%)
Time frame · At baseline and up to 76 weeks
Absolute change in KCCQ from baseline to 76 weeks (dimensionless)
Time frame · At baseline and up to 76 weeks
Registry description
Kansas City Cardiomyopathy Questionnaire (KCCQ) is a validated, disease-specific participant-reported outcome measure designed to assess heart failure-related health status. The study will administer the KCCQ 23-item version. All scores range from 0 to 100, with higher scores indicating fewer symptoms and better health status.
New use of oral loop diuretics during follow-up from baseline to 76 weeks, irrespective of symptoms (yes/no)
Time frame · At baseline and up to 76 weeks
Absolute change in systolic blood pressure (SBP) from baseline to 76 weeks (mmHg)
Time frame · At baseline and up to 76 weeks
Absolute change in fibrosis-4 index (FIB-4) from baseline (dimensionless)
Time frame · At baseline and up to 76 weeks
Absolute change in fatty liver index (FLI) from baseline to 76 weeks (dimensionless)
Time frame · At baseline and up to 76 weeks
Absolute change in hepatic steatosis index (HSI) from baseline to 76 weeks (dimensionless)
Time frame · At baseline and up to 76 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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