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

Boehringer Ingelheim

Status and phase: Begins enrollment this month; Phase 3

Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease; Obesity

Treatments: Combination Product: Survodutide; Combination Product: Placebo matching survodutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07850063

1111-1339-5364 (Registry Identifier)

2026-527091-88-00 (Registry Identifier)

1404-0128

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups, including a placebo group

Survodutide arm

Experimental group

Treatment:

Combination Product: Survodutide

Placebo arm

Placebo Comparator group

Treatment:

Combination Product: Placebo matching survodutide