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

29. oktober 2026 oppdatert av: Boehringer Ingelheim

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)

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

600

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Arizona
      • Peoria, Arizona, Forente stater, 85381
        • The Institute for Liver Health II DBA Arizona Clinical Trials
        • Ta kontakt med:
    • California
      • Los Angeles, California, Forente stater, 90048
      • Oxnard, California, Forente stater, 93030
      • Pasadena, California, Forente stater, 91105
      • West Hills, California, Forente stater, 91307
    • Florida
      • University Park, Florida, Forente stater, 34201
        • Covenant Metabolic Specialists, LLC - University Park
        • Ta kontakt med:
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160
      • Topeka, Kansas, Forente stater, 66606
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87109
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
      • Statesville, North Carolina, Forente stater, 28625
    • South Carolina
      • Summerville, South Carolina, Forente stater, 29485
    • Tennessee
      • Bristol, Tennessee, Forente stater, 37620
        • Internal Medicine and Pediatric Associates of Bristol, PC
        • Ta kontakt med:
    • Texas
      • Dallas, Texas, Forente stater, 75203
  • Kina
      • Chengdu, Kina, 610041
        • West China Hospital, Sichuan University
        • Ta kontakt med:
      • Luoyang, Kina, 471003
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Ta kontakt med:
      • Nanjing, Kina, 210011
        • The Second Affiliated Hospital of Nanjing Medical University
        • Ta kontakt med:
      • Shanghai, Kina, 200032
        • Zhongshan Hospital Affiliated to Fudan University
        • Ta kontakt med:
      • Shanghai, Kina, 200072
        • Shanghai Tenth People's Hospital
        • Ta kontakt med:
  • Spania
      • El Palmar, Spania, 30120
        • Hospital Universitario Virgen de la Arrixaca
        • Ta kontakt med:
      • Sanlúcar de Barrameda, Spania, 11540
      • Valencia, Spania, 46015
  • Storbritannia
      • Bradford, Storbritannia, BD9 6RJ
      • Leeds, Storbritannia, LS9 7TF
      • Leicester, Storbritannia, LE1 5WW
      • London, Storbritannia, SE1 9RT
      • London, Storbritannia, EC1A 7BE
      • Plymouth, Storbritannia, PL6 8DH
  • Tyskland
      • Bad Homburg, Tyskland, 61348
      • Erlangen, Tyskland, 91054
      • Freiburg im Breisgau, Tyskland, 79106
      • Leipzig, Tyskland, 04103
      • Mainz, Tyskland, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo arm
Kombinasjonsprodukt: Placebo matching survodutide

Placebo matching survodutide
Eksperimentell: Survodutide arm
Kombinasjonsprodukt: Survodutide

Survodutide

Andre navn:
  • BI456906

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Composite average Z-score (dimensionless) at Week 76 of cardiac structural and functional parameters
Tidsramme: At week 76
At week 76

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Relative change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from baseline to 76 weeks (%)
Tidsramme: At baseline and up to 76 weeks
At baseline and up to 76 weeks
Relative change in alanine aminotransferase (ALT) from baseline to 76 weeks (%)
Tidsramme: At baseline and up to 76 weeks
At baseline and up to 76 weeks
Absolute change in KCCQ from baseline to 76 weeks (dimensionless)
Tidsramme: At baseline and up to 76 weeks

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.
At baseline and up to 76 weeks
New use of oral loop diuretics during follow-up from baseline to 76 weeks, irrespective of symptoms (yes/no)
Tidsramme: At baseline and up to 76 weeks
At baseline and up to 76 weeks
Absolute change in systolic blood pressure (SBP) from baseline to 76 weeks (mmHg)
Tidsramme: At baseline and up to 76 weeks
At baseline and up to 76 weeks
Absolute change in fibrosis-4 index (FIB-4) from baseline (dimensionless)
Tidsramme: At baseline and up to 76 weeks
At baseline and up to 76 weeks
Absolute change in fatty liver index (FLI) from baseline to 76 weeks (dimensionless)
Tidsramme: At baseline and up to 76 weeks
At baseline and up to 76 weeks
Absolute change in hepatic steatosis index (HSI) from baseline to 76 weeks (dimensionless)
Tidsramme: At baseline and up to 76 weeks
At baseline and up to 76 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

2. november 2026

Primær fullføring (Antatt)

29. april 2029

Studiet fullført (Antatt)

29. april 2029

Datoer for studieregistrering

Først innsendt

25. september 2026

Først innsendt som oppfylte QC-kriteriene

25. september 2026

Først lagt ut (Faktiske)

30. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1404-0128
  • 1111-1339-5364 (Registeridentifikator: WHO International Clinical Trials Registry Platform (ICTRP))
  • 2026-527091-88-00 (Registeridentifikator: CTIS (EU))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD-delingstidsramme

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

Tilgangskriterier for IPD-deling

For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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