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Sikkerhed og effekt af Bimagrumab og Semaglutid hos voksne, der er overvægtige eller fede

11. juni 2026 opdateret af: Eli Lilly and Company

En randomiseret, dobbeltblind, placebokontrolleret multicenterundersøgelse af intravenøs bimagrumab, alene eller i tillæg til Open Label subkutan semaglutid, for at undersøge effektiviteten og sikkerheden hos overvægtige eller fede mænd og kvinder

Et fase 2-studie til vurdering af effekten af ​​bimagrumab alene eller som supplement til semaglutid for at vurdere effektivitet og sikkerhed hos overvægtige eller fede mænd og kvinder

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Denne undersøgelse undersøger, om bimagrumab ud over standardbehandling semaglutid er i stand til at bevare/øge muskelmasse i nærvær af vægt- og/eller fedtmassetab. Det forventes, at fald i taljeomkreds vil følge et lignende mønster som vægttab hos forsøgspersoner behandlet med en kombination af bimagrumab og semaglutid.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

507

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Australien
      • Camberwell, Australien, 3124
        • Emeritus Research
    • New South Wales
      • Brookvale, New South Wales, Australien, 2100
        • Northern Beaches Clinical Research
      • Saint Leonards, New South Wales, Australien, 2065
        • Royal North Shore Hospital
    • Queensland
      • Morayfield, Queensland, Australien, 4506
        • University of The Sunshine Coast Morayfield
      • Sippy Downs, Queensland, Australien, 04556
        • University of the Sunshine Coast Clinical Trial Centre
      • South Brisbane, Queensland, Australien, 4101
        • University of The Sunshine Coast South Brisbane
      • Southport, Queensland, Australien, 4215
        • Gold Coast University Hospital
    • Victoria
      • Heidelberg Heights, Victoria, Australien, 3081
        • Austin Health
  • Forenede Stater
    • Alabama
      • Anniston, Alabama, Forenede Stater, 36207
        • Pinnacle Research Group, LLC
      • Cullman, Alabama, Forenede Stater, 35055
        • Cullman Clinical Trials
    • Florida
      • Hialeah, Florida, Forenede Stater, 33012
        • Indago Research & Health Center, Inc
      • Jacksonville, Florida, Forenede Stater, 32256
        • Clinical Neuroscience Solutions Inc
      • Lake Worth, Florida, Forenede Stater, 33461
        • Altus Research
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70808
        • Pennington Biomedical Research Center
    • New York
      • New York, New York, Forenede Stater, 10021
        • Weill Cornell Medical College
    • North Carolina
      • Monroe, North Carolina, Forenede Stater, 28112
        • Monroe Biomedical Research
    • South Carolina
      • Columbia, South Carolina, Forenede Stater, 29322
        • SPICA Clinical
    • Texas
      • Sugar Land, Texas, Forenede Stater, 77479
        • Mt. Olympus Medical Research
  • New Zealand
      • Auckland, New Zealand, 2025
        • Middlemore Hospital
      • Auckland, New Zealand, 1010
        • Optimal Clinical Trials
      • Auckland, New Zealand, 1010
        • New Zealand Clinical Research Auckland
      • Christchurch, New Zealand, 8011
        • New Zealand Clinical Research Christchurch
      • Hamilton, New Zealand, 3200
        • Lakeland Clinical Trials Waikato
      • Nelson, New Zealand, 7011
        • Southern Clinical Trials Tasman
    • Canterbury
      • Beckenham, Christchurch, Canterbury, New Zealand, 8013
        • Southern Clinical Trials Ltd
    • Wellington Region
      • Newtown, Wellington Region, New Zealand, 6242
        • P3 Research

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 til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Der skal indhentes et skriftligt informeret samtykke, før der udføres undersøgelsesrelaterede vurderinger.

  • Mænd og kvinder mellem 18 og 80 år, inklusive; kvinder i den fødedygtige alder (defineret som dem, der ikke er post-menopausal eller post-kirurgisk sterilisation) skal opfylde begge følgende kriterier:

    • To negative graviditetstests (ved screening og ved randomisering, før dosering)
    • Brug af intrauterin enhed fra mindst 3 måneder før screening til mindst 4 måneder efter den sidste dosis bimagrumab/placebo i.v. og en yderligere præventionsmetode (barriere)
  • Body mass index (BMI) ≥ 30 eller BMI ≥ 27 med en eller flere fedme-associerede komorbiditeter (f.eks. hypertension, insulinresistens, søvnapnø eller dyslipidæmi)
  • Stabil kropsvægt (± 5 kg) inden for 90 dage efter screening og kropsvægt
  • Har en historie med mindst én selvrapporteret mislykket adfærdsmæssig indsats for at tabe kropsvægt
  • I stand til at kommunikere godt med efterforskeren, overholde undersøgelseskravene og overholde kost- og aktivitetsprogrammerne i undersøgelsens varighed

Ekskluderingskriterier:

  • Anamnese med eller kendt overfølsomhed over for monoklonale antistoffer eller en kontraindikation for semaglutid (Ozempic® eller Wegovy®)
  • Brug af andre forsøgslægemidler på tidspunktet for tilmeldingen eller inden for 30 dage eller 5 halveringstider efter tilmeldingen, alt efter hvad der er længst, eller længere, hvis det kræves af lokale regler
  • Behandling med enhver form for medicin til indikation af fedme inden for de seneste 30 dage før screening
  • Diagnose af diabetes (f.eks. HbA1c ≥ 6,5%), der kræver aktuel brug af ethvert antidiabetisk lægemiddel. Bemærk: Metabolisk syndrom er ikke en udelukkelse, selvom det behandles med et antidiabetisk lægemiddel såsom metformin eller en SGLT2-hæmmer. En diagnose af prædiabetes eller nedsat glukosetolerance, der udelukkende håndteres med ikke-farmakologiske tilgange (f.eks. diæt og motion) er ikke en udelukkelse.
  • Enhver kronisk infektion, der sandsynligvis vil forstyrre undersøgelsesudførelse eller -fortolkning, såsom hepatitis B (HBV), hepatitis C (HCV) eller human immundefektvirus (HIV). Anamnese med succesfuldt behandlet hepatitis A eller hepatitis C er ikke udelukkende. Aktiv COVID-19 infektion.
  • Donation eller tab af 400 ml eller mere blod inden for 8 uger før initial dosering, eller længere, hvis det kræves af lokal regulering, eller plasmadonation (> 250 ml) inden for 14 dage før den første dosis
  • Enhver lidelse, uvilje eller manglende evne, der ikke er dækket af nogen af ​​de andre eksklusionskriterier, som efter efterforskerens mening kan bringe forsøgspersonens sikkerhed eller overholdelse af protokollen i fare

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: Faktoriel opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
Andet: Placebo
Placebo
Eksperimentel: 10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
Biologisk: Bimagrumab
Humant monoklonalt antistof mod activinreceptoren type II
Eksperimentel: 30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
Biologisk: Bimagrumab
Humant monoklonalt antistof mod activinreceptoren type II
Eksperimentel: Placebo + 1.0 mg Semaglutide

Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:

  • Weeks 1 to 4: 0.25 mg
  • Weeks 5 to 8: 0.5 mg
  • Weeks 9 to 71: 1.0 mg
Andet: Placebo
Placebo
Medicin: Semaglutid
Glukagon-lignende peptid-1 (GLP-1) receptoragonist
Andre navne:
  • Ozempisk
  • Wegovy
Eksperimentel: Placebo + 2.4 mg Semaglutide

Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:

  • Weeks 1 to 4: 0.25 mg
  • Weeks 5 to 8: 0.5 mg
  • Weeks 9 to 12: 1.0 mg
  • Weeks 13 to 16: 1.7 mg
  • Weeks 17 to 71: 2.4 mg
Andet: Placebo
Placebo
Medicin: Semaglutid
Glukagon-lignende peptid-1 (GLP-1) receptoragonist
Andre navne:
  • Ozempisk
  • Wegovy
Eksperimentel: 10 mg/kg Bimagrumab + 1.0 mg Semaglutide

Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:

  • Weeks 1 to 4: 0.25 mg
  • Weeks 5 to 8: 0.5 mg
  • Weeks 9 to 71: 1.0 mg
Medicin: Semaglutid
Glukagon-lignende peptid-1 (GLP-1) receptoragonist
Andre navne:
  • Ozempisk
  • Wegovy
Biologisk: Bimagrumab
Humant monoklonalt antistof mod activinreceptoren type II
Eksperimentel: 10 mg/kg Bimagrumab + 2.4 mg Semaglutide

Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:

  • Weeks 1 to 4: 0.25 mg
  • Weeks 5 to 8: 0.5 mg
  • Weeks 9 to 12: 1.0 mg
  • Weeks 13 to 16: 1.7 mg
  • Weeks 17 to 71: 2.4 mg
Medicin: Semaglutid
Glukagon-lignende peptid-1 (GLP-1) receptoragonist
Andre navne:
  • Ozempisk
  • Wegovy
Biologisk: Bimagrumab
Humant monoklonalt antistof mod activinreceptoren type II
Eksperimentel: 30 mg/kg Bimagrumab + 1.0 mg Semaglutide

Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:

  • Weeks 1 to 4: 0.25 mg
  • Weeks 5 to 8: 0.5 mg
  • Weeks 9 to 71: 1.0 mg
Medicin: Semaglutid
Glukagon-lignende peptid-1 (GLP-1) receptoragonist
Andre navne:
  • Ozempisk
  • Wegovy
Biologisk: Bimagrumab
Humant monoklonalt antistof mod activinreceptoren type II
Eksperimentel: 30 mg/kg Bimagrumab + 2.4 mg Semaglutide

Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:

  • Weeks 1 to 4: 0.25 mg
  • Weeks 5 to 8: 0.5 mg
  • Weeks 9 to 12: 1.0 mg
  • Weeks 13 to 16: 1.7 mg
  • Weeks 17 to 71: 2.4 mg
Medicin: Semaglutid
Glukagon-lignende peptid-1 (GLP-1) receptoragonist
Andre navne:
  • Ozempisk
  • Wegovy
Biologisk: Bimagrumab
Humant monoklonalt antistof mod activinreceptoren type II

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Body Weight at Week 48
Tidsramme: Baseline, Week 48
Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 48

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procentdel af deltagere med kropsmasseindeks (BMI) kategorier ved baseline og uge 48
Tidsramme: Baseline, uge 48

BMI -kategorier:

jeg. Sund vægt: 18,5 kg (kg)/meter (m) ² til 24,9 kg/m² ii. Overvægt: 25 kg/m² til 29,9 kg/m² III. Fedme Klasse 1: 30 kg/m² til 34,9 kg/m² IV. Fedme Klasse II: 35 kg/m² til 39,9 kg/m² v. Fedme Klasse III: ≥ 40 kg/m2
Baseline, uge 48
Procentdel af deltagere med baseline-talje-til-højde-forholdet (WTHR) kategori af <0,5 med ændring fra baseline i kategorier til talje til højde (WHTR-forholdet) i uge 48
Tidsramme: Baseline op til 48 uger
WHTR -forholdskategorier: <0,5; 0,5-0,59; ≥0,6
Baseline op til 48 uger
Procentdel af deltagere med baseline WTHR-kategori af 0,5-0,59 har ændringer fra baseline i kategorier til talje til højde (WHTR-forholdet) i uge 48
Tidsramme: Baseline op til 48 uger
WHTR -forholdskategorier: <0,5; 0,5-0,59; ≥0,6
Baseline op til 48 uger
Procentdel af deltagere med baseline WTHR-kategori ≥0,6 At have ændringer fra baseline i kategorier i talje til højde (WHTR-forholdet) i uge 48
Tidsramme: Baseline op til 48 uger
WHTR -forholdskategorier: <0,5; 0,5-0,59; ≥0,6
Baseline op til 48 uger
Ændring fra baseline i livskvalitet Kort form 36 version 2 (SF-36V2) Akut form Fysisk funktionsdomænescore i uge 24
Tidsramme: Baseline, uge 24
SF-36V2 akut form vurderer sundhedsrelateret livskvalitet (HRQOL) på 8 domæner: fysisk funktion, rollefysisk, kropslig smerte, generel sundhed, vitalitet, social funktion, rollemotionel og mental sundhed. Det fysiske fungerende domæne vurderer begrænsninger på grund af helbredet "nu" og består af 10-artikler, der hver især er klassificeret på en 3-punkts Likert-skala. Scoring af domænet er normbaseret og præsenteret i form af T-scoringer med et gennemsnit på 50 og standardafvigelse på 10; Højere score indikerer bedre niveauer af funktion. Område kan ikke specificeres i normbaserede scoringer.
Baseline, uge 24
Ændring fra baseline i livskvalitet SF-36V2 Akut form Fysisk funktionsdomæne score uge 48
Tidsramme: Baseline, uge 48
SF-36V2 akut form vurderer HRQOL på 8 domæner: fysisk funktion, rollefysisk, kropslig smerte, generel sundhed, vitalitet, social funktion, rolle-emotionel og mental sundhed. Det fysiske fungerende domæne vurderer begrænsninger på grund af sundhed "nu" og består af 10 poster, der hver især er klassificeret på en 3-punkts Likert-skala. Scoring af domænet er normbaseret og præsenteret i form af T-scoringer med et gennemsnit på 50 og standardafvigelse på 10; Højere score indikerer bedre niveauer af funktion. Rækkevidde kan ikke specificeres i normbaserede score
Baseline, uge 48
Skift fra baseline i livskvalitet SF-36V2 Akut form Total score i uge 48
Tidsramme: Baseline, uge 48
SF-36 er et deltagerrapporteret resultatmål, der evaluerer deltagerens sundhedsstatus. Det omfatter 36 genstande, der dækker 8 domæner: fysisk funktion, rolle fysisk, rolle følelsesmæssig, kropslig smerte, vitalitet, social funktion, mental sundhed og generel sundhed. Elementer besvares på Likert -skalaer med forskellige længder. De 8 domæner er omgrupperet til MCS og PCS for at opnå en total score i området fra 0 til 100, med højere score, der indikerer bedre niveauer af funktion og/eller bedre helbred.
Baseline, uge 48
Ændring fra baseline i påvirkning af vægt på kvaliteten af livslite-kliniske forsøg version (IWQOL-Lite-CT) fysisk funktionsscore og total score i uge 24
Tidsramme: Baseline, uge 24
IWQOL-LITE-CT er et 20-punkts, fedme-specifikt Pro-instrument udviklet til brug i kliniske fedmeforsøg. Den vurderer 2 primære domæner af fedme-relateret sundhedsrelateret livskvalitet (HRQOL): fysiske (7 genstande) og psykosociale (13 genstande). Hvert element er vurderet på en skala fra 0 (værst) til 100 (bedste), med højere score, der indikerer bedre funktionsniveauer. IWQOL-LITE-CT leverer sammensatte score for hvert domæne såvel som en total score, alt sammen fra 0 til 100. Højere score afspejler bedre niveauer af funktion og livskvalitet. Dette slutpunkt viser resultater for 'fysisk funktion score' og 'total score.'
Baseline, uge 24
Skift fra baseline i IWQOL-LITE-CT Fysisk funktionsscore og total score i uge 48
Tidsramme: Baseline, uge 48
IWQOL-LITE-CT er et 20-punkts, fedme-specifikt Pro-instrument udviklet til brug i kliniske fedmeforsøg. Den vurderer 2 primære domæner af fedme-relateret sundhedsrelateret livskvalitet (HRQOL): fysiske (7 genstande) og psykosociale (13 genstande). Hvert element er vurderet på en skala fra 0 (værst) til 100 (bedste), med højere score, der indikerer bedre funktionsniveauer. IWQOL-LITE-CT leverer sammensatte score for hvert domæne såvel som en total score, alt sammen fra 0 til 100. Højere score afspejler bedre niveauer af funktion og livskvalitet. Dette slutpunkt viser resultater for 'fysisk funktion score' og 'total score.'
Baseline, uge 48
Skift fra baseline i IWQOL-LITE-CT Fysisk funktionsresultat og total score i uge 72
Tidsramme: Baseline, uge 72
IWQOL-LITE-CT er et 20-punkts, fedme-specifikt Pro-instrument udviklet til brug i kliniske fedmeforsøg. Den vurderer 2 primære domæner af fedme-relateret sundhedsrelateret livskvalitet (HRQOL): fysiske (7 genstande) og psykosociale (13 genstande). Hvert element er vurderet på en skala fra 0 (værst) til 100 (bedste), med højere score, der indikerer bedre funktionsniveauer. IWQOL-LITE-CT leverer sammensatte score for hvert domæne såvel som en total score, alt sammen fra 0 til 100. Højere score afspejler bedre niveauer af funktion og livskvalitet. Dette slutpunkt viser resultater for 'fysisk funktion score' og 'total score.'
Baseline, uge 72
Change From Baseline in Waist Circumference at Week 48
Tidsramme: Baseline, Week 48
Waist circumference was measured in standing position with a non-stretchable measuring tape to the nearest 0.1 centimeter (cm). Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 48
Change From Baseline in Waist Circumference at Week 72
Tidsramme: Baseline, Week 72
Waist circumference was measured in standing position with a non-stretchable measuring tape to the nearest 0.1 cm. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 72
Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48
Tidsramme: Baseline, Week 48
Change from baseline in total body fat mass in kg was assessed by Dual energy X-ray absorptiometry (DXA). Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 48
Change From Baseline in Total Body Fat Mass in kg at Week 72
Tidsramme: Baseline, Week 72
Change from baseline in total body fat mass in kg was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 72
Percent Change From Baseline for Fat Mass by DXA at Week 48
Tidsramme: Baseline, Week 48
Percent change from baseline for fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 48
Percent Change From Baseline for Fat Mass by DXA at Week 72
Tidsramme: Baseline, Week 72
Percent change from baseline for fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 72
Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48
Tidsramme: Baseline, Week 48
Change from baseline in VAT, SAT and trunk fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 48
Change From Baseline in VAT, SAT and Trunk Fat Mass by DXA at Week 72
Tidsramme: Baseline, Week 72
Change from baseline in VAT, SAT and trunk fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 72
Percentage of Participants With Reduction in Waist Circumference Greater Than or Equal to (≥) 5 cm at Week 48
Tidsramme: Week 48
Waist circumference was measured in a standing position with a non-stretchable measuring tape to the nearest 0.1 cm. Only participants with non-missing baseline value were included in analysis.
Week 48
Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48
Tidsramme: Week 48
Body weight was measured in kgs to the nearest 0.1 kg. Only participants with non-missing baseline value were included in analysis.
Week 48
Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48
Tidsramme: Week 48
Only participants with non-missing baseline value were included in analysis.
Week 48
Percentage of Participants Achieving Fat Mass ≥ 10% Reduction With <5% Decrease in Lean Mass by DXA at Week 48
Tidsramme: Week 48
Only participants with non-missing baseline value were included in analysis.
Week 48
Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48
Tidsramme: Week 48
Fat Lost Index = % change in fat mass/% change in lean mass + % change in fat mass. Only participants with non-missing baseline value were included in analysis.
Week 48
Change From Baseline in Body Fat Mass by Bioelectrical Impedance Analysis (BIA) at Week 48
Tidsramme: Baseline, Week 48
Change from baseline in body fat mass was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 48
Change From Baseline in Body Fat Mass by BIA at Week 72
Tidsramme: Baseline, Week 72
Change from baseline in body fat mass was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 72
Percent Change From Baseline in Body Fat by BIA at Week 48
Tidsramme: Baseline, Week 48
Percent change from baseline in Body fat was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 48
Percent Change From Baseline in Body Fat by BIA at Week 72
Tidsramme: Baseline, Week 72
Percent change from baseline in Body fat was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 72
Change From Baseline in Lean Mass by DXA at Week 48
Tidsramme: Baseline, Week 48
Change from baseline in lean mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 48
Change From Baseline in Lean Mass by DXA at Week 72
Tidsramme: Baseline, Week 72
Change from baseline in lean mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 72
Percent Change From Baseline in Lean Body Mass by DXA at Week 48
Tidsramme: Baseline, Week 48
Percent change from baseline in lean body mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 48
Percent Change From Baseline in Lean Body Mass by DXA at Week 72
Tidsramme: Baseline, Week 72
Percent change from baseline in lean body mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 72
Percent Change From Baseline in Appendicular Lean Mass by DXA at Week 48
Tidsramme: Baseline, Week 48
Percent change from baseline in appendicular lean mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 48
Percent Change From Baseline in Appendicular Lean Mass by DXA at Week 72
Tidsramme: Baseline, Week 72
Percent change from baseline in appendicular lean mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 72
Change From Baseline in Lean Mass (kg) by BIA at Week 48
Tidsramme: Baseline, Week 48
Change from baseline in lean mass (kg) was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 48
Change From Baseline in Lean Mass (kg) by BIA at Week 72
Tidsramme: Baseline, Week 72
Change from baseline in lean mass (kg) was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 72
Percent Change From Baseline in Lean Body Mass by BIA at Week 48
Tidsramme: Baseline, Week 48
Percent change from baseline in lean body mass was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 48
Percent Change From Baseline in Lean Body Mass by BIA at Week 72
Tidsramme: Baseline, Week 72
Percent change from baseline in lean body mass was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 72
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 48
Tidsramme: Baseline, 48 weeks
HbA1c is the glycosylated fraction of hemoglobin A. It is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, 48 weeks
Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score Week 24
Tidsramme: Baseline, Week 24
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into (mental component score [MCS] and physical component score [PCS] to obtain a total score ranging from 0 to 100, with higher scores indicating better levels of function and/or better health.
Baseline, Week 24
Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 72
Tidsramme: Baseline, Week 72
The SF-36v2 acute form assesses HRQoL on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" and consists of 10 items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores
Baseline, Week 72
Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 72
Tidsramme: Baseline, Week 72
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into MCS and PCS to obtain a total score ranging from 0 to 100, with higher scores indicating better levels of function and/or better health.
Baseline, Week 72

Samarbejdspartnere og efterforskere

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

Sponsor

Eli Lilly and Company

Samarbejdspartnere

Versanis Bio, Inc.

Efterforskere

  • Studieleder: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

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.

Generelle publikationer

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 (Faktiske)

16. november 2022

Primær færdiggørelse (Faktiske)

16. maj 2024

Studieafslutning (Faktiske)

14. juni 2025

Datoer for studieregistrering

Først indsendt

16. oktober 2022

Først indsendt, der opfyldte QC-kriterier

9. november 2022

Først opslået (Faktiske)

14. november 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 18828
  • VER201-PH2-031 (Anden identifikator: Versanis)
  • J4Z-MC-GIDA (Anden identifikator: Eli Lilly and Company)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymiserede individuelle data på patientniveau vil blive leveret i et sikkert adgangsmiljø efter godkendelse af et forskningsforslag og en underskrevet datadelingsaftale.

IPD-delingstidsramme

Data er tilgængelige 6 måneder efter den primære offentliggørelse og godkendelse af den undersøgte indikation i USA og EU, alt efter hvad der er senere. Data vil være tilgængelige på ubestemt tid for anmodning.

IPD-delingsadgangskriterier

Et forskningsforslag skal godkendes af et uafhængigt bedømmelsespanel, og forskere skal underskrive en datadelingsaftale.

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 .

Kliniske forsøg med Placebo

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Betingelser

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