Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

600

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Det Forenede Kongerige
      • Bradford, Det Forenede Kongerige, BD9 6RJ
      • Leeds, Det Forenede Kongerige, LS9 7TF
      • Leicester, Det Forenede Kongerige, LE1 5WW
      • London, Det Forenede Kongerige, SE1 9RT
      • London, Det Forenede Kongerige, EC1A 7BE
      • Plymouth, Det Forenede Kongerige, PL6 8DH
  • Forenede Stater
    • Arizona
      • Peoria, Arizona, Forenede Stater, 85381
        • The Institute for Liver Health II DBA Arizona Clinical Trials
        • Kontakt:
    • California
      • Los Angeles, California, Forenede Stater, 90048
      • Oxnard, California, Forenede Stater, 93030
      • Pasadena, California, Forenede Stater, 91105
      • West Hills, California, Forenede Stater, 91307
    • Florida
      • University Park, Florida, Forenede Stater, 34201
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
      • Topeka, Kansas, Forenede Stater, 66606
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87109
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
      • Statesville, North Carolina, Forenede Stater, 28625
    • South Carolina
      • Summerville, South Carolina, Forenede Stater, 29485
    • Tennessee
      • Bristol, Tennessee, Forenede Stater, 37620
        • Internal Medicine and Pediatric Associates of Bristol, PC
        • Kontakt:
    • Texas
      • Dallas, Texas, Forenede Stater, 75203
  • Kina
      • Chengdu, Kina, 610041
        • West China Hospital, Sichuan University
        • Kontakt:
      • Luoyang, Kina, 471003
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Kontakt:
      • Nanjing, Kina, 210011
        • The Second Affiliated Hospital of Nanjing Medical University
        • Kontakt:
      • Shanghai, Kina, 200032
        • Zhongshan Hospital Affiliated to Fudan University
        • Kontakt:
      • Shanghai, Kina, 200072
        • Shanghai Tenth People's Hospital
        • Kontakt:
  • Spanien
      • El Palmar, Spanien, 30120
        • Hospital Universitario Virgen de la Arrixaca
        • Kontakt:
      • Sanlúcar de Barrameda, Spanien, 11540
      • Valencia, Spanien, 46015
  • 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
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo arm
Kombinationsprodukt: Placebo matching survodutide

Placebo matching survodutide
Eksperimentel: Survodutide arm
Kombinationsprodukt: Survodutide

Survodutide

Andre navne:
  • BI456906

Hvad måler undersøgelsen?

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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

2. november 2026

Primær færdiggørelse (Anslået)

29. april 2029

Studieafslutning (Anslået)

29. april 2029

Datoer for studieregistrering

Først indsendt

25. september 2026

Først indsendt, der opfyldte QC-kriterier

25. september 2026

Først opslået (Faktiske)

30. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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.

IPD-delingsadgangskriterier

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 Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner