Sikkerhet og effekt av Bimagrumab og Semaglutid hos voksne som er overvektige eller overvektige
11. juni 2026 oppdatert av: Eli Lilly and Company
En randomisert, dobbeltblind, placebokontrollert multisenterstudie av intravenøs bimagrumab, alene eller i tillegg til åpent subkutan semaglutid, for å undersøke effektiviteten og sikkerheten hos overvektige eller overvektige menn og kvinner
En fase 2-studie for å vurdere effekten av bimagrumab alene eller i tillegg til semaglutid for å vurdere effekt og sikkerhet hos overvektige eller overvektige menn og kvinner
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Denne studien undersøker om bimagrumab i tillegg til standardbehandling semaglutid er i stand til å bevare/øke muskelmasse i nærvær av vekt og/eller fettmassetap.
Det forventes at reduksjon i midjeomkrets vil følge et lignende mønster som vekttap hos pasienter behandlet med en kombinasjon av bimagrumab og semaglutid.
Studietype
Intervensjonell
Registrering (Faktiske)
507
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Camberwell, Australia, 3124
- Emeritus Research
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New South Wales
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Brookvale, New South Wales, Australia, 2100
- Northern Beaches Clinical Research
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Saint Leonards, New South Wales, Australia, 2065
- Royal North Shore Hospital
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Queensland
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Morayfield, Queensland, Australia, 4506
- University of The Sunshine Coast Morayfield
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Sippy Downs, Queensland, Australia, 04556
- University of the Sunshine Coast Clinical Trial Centre
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South Brisbane, Queensland, Australia, 4101
- University of The Sunshine Coast South Brisbane
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Southport, Queensland, Australia, 4215
- Gold Coast University Hospital
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Victoria
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Heidelberg Heights, Victoria, Australia, 3081
- Austin Health
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Alabama
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Anniston, Alabama, Forente stater, 36207
- Pinnacle Research Group, LLC
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Cullman, Alabama, Forente stater, 35055
- Cullman Clinical Trials
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Florida
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Hialeah, Florida, Forente stater, 33012
- Indago Research & Health Center, Inc
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Jacksonville, Florida, Forente stater, 32256
- Clinical Neuroscience Solutions Inc
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Lake Worth, Florida, Forente stater, 33461
- Altus Research
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Louisiana
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Baton Rouge, Louisiana, Forente stater, 70808
- Pennington Biomedical Research Center
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New York
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New York, New York, Forente stater, 10021
- Weill Cornell Medical College
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North Carolina
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Monroe, North Carolina, Forente stater, 28112
- Monroe Biomedical Research
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South Carolina
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Columbia, South Carolina, Forente stater, 29322
- SPICA Clinical
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Texas
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Sugar Land, Texas, Forente stater, 77479
- Mt. Olympus Medical Research
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Auckland, New Zealand, 2025
- Middlemore Hospital
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Auckland, New Zealand, 1010
- Optimal Clinical Trials
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Auckland, New Zealand, 1010
- New Zealand Clinical Research Auckland
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Christchurch, New Zealand, 8011
- New Zealand Clinical Research Christchurch
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Hamilton, New Zealand, 3200
- Lakeland Clinical Trials Waikato
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Nelson, New Zealand, 7011
- Southern Clinical Trials Tasman
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Canterbury
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Beckenham, Christchurch, Canterbury, New Zealand, 8013
- Southern Clinical Trials Ltd
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Wellington Region
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Newtown, Wellington Region, New Zealand, 6242
- P3 Research
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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 til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
- Et skriftlig informert samtykke må innhentes før noen studierelaterte vurderinger utføres.
Menn og kvinner mellom 18 og 80 år, inklusive; kvinner i fertil alder (definert som de som ikke er post-menopausal eller post-kirurgisk sterilisering) må oppfylle begge følgende kriterier:
- To negative graviditetstester (ved screening og ved randomisering, før dosering)
- Bruk av intrauterin enhet, fra minst 3 måneder før screening til minst 4 måneder etter siste dose bimagrumab/placebo i.v., og en ekstra prevensjonsmetode (barriere)
- Kroppsmasseindeks (BMI) ≥ 30 eller BMI ≥ 27 med en eller flere fedme-assosierte komorbiditeter (f.eks. hypertensjon, insulinresistens, søvnapné eller dyslipidemi)
- Stabil kroppsvekt (± 5 kg) innen 90 dager etter screening, og kroppsvekt
- Har en historie med minst én selvrapportert mislykket atferdsforsøk for å gå ned i kroppsvekt
- Kunne kommunisere godt med etterforskeren, overholde studiekravene og følge kostholds- og aktivitetsprogrammene under studiens varighet
Ekskluderingskriterier:
- Anamnese med eller kjent overfølsomhet overfor monoklonale antistoffmedisiner eller en kontraindikasjon mot semaglutid (Ozempic® eller Wegovy®)
- Bruk av andre undersøkelseslegemidler på registreringstidspunktet eller innen 30 dager eller 5 halveringstider etter registrering, avhengig av hva som er lengst, eller lengre hvis det kreves av lokale forskrifter
- Behandling med hvilken som helst medisin for indikasjon på fedme innen de siste 30 dagene før screening
- Diagnose av diabetes (f.eks. HbA1c ≥ 6,5 %) som krever nåværende bruk av et hvilket som helst antidiabetisk stoff. En diagnose av prediabetes eller nedsatt glukosetoleranse som utelukkende håndteres med ikke-farmakologiske tilnærminger (f.eks. kosthold og trening) er ikke en eksklusjon.
- Eventuelle kroniske infeksjoner som sannsynligvis vil forstyrre studiegjennomføring eller tolkning som hepatitt B (HBV), hepatitt C (HCV) eller humant immunsviktvirus (HIV). Anamnese med vellykket behandling av hepatitt A eller hepatitt C er ikke utelukkende. Aktiv COVID-19-infeksjon.
- Donasjon eller tap av 400 ml eller mer blod innen 8 uker før første dose, eller lenger hvis det kreves av lokal forskrift, eller plasmadonasjon (> 250 ml) innen 14 dager før første dose
- Enhver forstyrrelse, uvilje eller manglende evne som ikke dekkes av noen av de andre eksklusjonskriteriene, som etter etterforskerens mening kan sette forsøkspersonens sikkerhet eller overholdelse av protokollen i fare
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: Faktoriell oppgave
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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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.
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Placebo
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Eksperimentell: 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.
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Humant monoklonalt antistoff mot aktivinreseptoren type II
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Eksperimentell: 30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
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Humant monoklonalt antistoff mot aktivinreseptoren type II
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Eksperimentell: 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:
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Placebo
Glukagon-lignende peptid-1 (GLP-1) reseptoragonist
Andre navn:
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Eksperimentell: 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:
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Placebo
Glukagon-lignende peptid-1 (GLP-1) reseptoragonist
Andre navn:
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Eksperimentell: 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:
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Glukagon-lignende peptid-1 (GLP-1) reseptoragonist
Andre navn:
Humant monoklonalt antistoff mot aktivinreseptoren type II
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Eksperimentell: 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:
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Glukagon-lignende peptid-1 (GLP-1) reseptoragonist
Andre navn:
Humant monoklonalt antistoff mot aktivinreseptoren type II
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Eksperimentell: 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:
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Glukagon-lignende peptid-1 (GLP-1) reseptoragonist
Andre navn:
Humant monoklonalt antistoff mot aktivinreseptoren type II
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Eksperimentell: 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:
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Glukagon-lignende peptid-1 (GLP-1) reseptoragonist
Andre navn:
Humant monoklonalt antistoff mot aktivinreseptoren type II
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change From Baseline in Body Weight at Week 48
Tidsramme: Baseline, Week 48
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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.
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Baseline, Week 48
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Prosentandel av deltakere med Body Mass Index (BMI) kategorier ved baseline og uke 48
Tidsramme: Baseline, uke 48
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BMI -kategorier: jeg. Sunn vekt: 18,5 kilo (kg)/meter (m) ² til 24,9 kg/m² II. Overvekt: 25 kg/m² til 29,9 kg/m² III. Overvekt klasse 1: 30 kg/m² til 34,9 kg/m² IV. Overvekt Klasse II: 35 kg/m² til 39,9 kg/m² v. Overvekt Klasse III: ≥ 40 kg/m2 |
Baseline, uke 48
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Prosentandel av deltakere med baseline midje-til-høyde-forhold (WTHR) kategori på <0,5 som har endring fra baseline i midje-til-høyde-forhold (WHTR Ratio) kategorier i uke 48
Tidsramme: Baseline opp til 48 uker
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WHT -forholdskategorier: <0,5; 0,5-0,59;
≥0,6
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Baseline opp til 48 uker
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Prosentandel av deltakere med baseline WTHHR-kategori på 0,5-0,59 som har endring fra baseline i midje-til-høyde-forhold (WHTR Ratio) kategorier i uke 48
Tidsramme: Baseline opp til 48 uker
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WHT -forholdskategorier: <0,5; 0,5-0,59;
≥0,6
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Baseline opp til 48 uker
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Prosentandel av deltakere med baseline wthr kategori ≥0.6 har endring fra baseline i midje til høyde forhold (WHTR-forhold) kategorier i uke 48
Tidsramme: Baseline opp til 48 uker
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WHT -forholdskategorier: <0,5; 0,5-0,59;
≥0,6
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Baseline opp til 48 uker
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Endring fra baseline i livskvalitet Kort form 36 versjon 2 (SF-36V2) Akutt form Fysisk fungerende domenescore i uke 24
Tidsramme: Baseline, uke 24
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SF-36V2 akutt form vurderer helserelatert livskvalitet (HRQOL) på 8 domener: fysisk funksjon, rolle-fysisk, kroppslig smerte, generell helse, vitalitet, sosial funksjon, rollemosjonell og mental helse.
Det fysiske fungerende domenet vurderer begrensninger på grunn av helse "nå" og består av 10-elementer, hver vurdert på en 3-punkts Likert-skala.
Scoring av domenet er normbasert og presentert i form av T-score, med et gjennomsnitt på 50 og standardavvik på 10; Høyere score indikerer bedre funksjonsnivåer.
Område kan ikke spesifiseres i normbaserte score.
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Baseline, uke 24
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Endring fra baseline i livskvalitet SF-36V2 Akutt form Fysisk fungerende domenescore Uke 48
Tidsramme: Baseline, uke 48
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SF-36V2 akutt form vurderer HRQOL på 8 domener: fysisk funksjon, rolle-fysisk, kroppslig smerte, generell helse, vitalitet, sosial funksjon, rolleemosjonell og mental helse.
Det fysiske fungerende domenet vurderer begrensninger på grunn av helse "nå" og består av 10 elementer, hver vurdert på en 3-punkts Likert-skala.
Scoring av domenet er normbasert og presentert i form av T-score, med et gjennomsnitt på 50 og standardavvik på 10; Høyere score indikerer bedre funksjonsnivåer.
Område kan ikke spesifiseres i normbaserte score
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Baseline, uke 48
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Endring fra baseline i livskvalitet SF-36V2 Akutt form Total poengsum på uke 48
Tidsramme: Baseline, uke 48
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SF-36 er et deltakerrapportert resultatmål som evaluerer deltakerens helsetilstand.
Det består av 36 elementer som dekker 8 domener: fysisk funksjon, rolle fysisk, rolle emosjonell, kroppslig smerte, vitalitet, sosial funksjon, mental helse og generell helse.
Elementer blir besvart på Likert skalaer i varierende lengder.
De 8 domenene blir omgruppert til MC -er og PC -er for å oppnå en total score fra 0 til 100, med høyere score som indikerer bedre funksjonsnivåer og/eller bedre helse.
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Baseline, uke 48
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Endring fra baseline i innvirkning av vekt på kvaliteten på livslitt-kliniske forsøksversjon (IWQOL-Lite-CT) Fysisk funksjonspoeng og total score i uke 24
Tidsramme: Baseline, uke 24
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IWQOL-Lite-CT er et 20-punkts, overvektsspesifikt Pro-instrument utviklet for bruk i overvekt kliniske studier.
Den vurderer 2 primære domener av overvektrelatert helserelatert livskvalitet (HRQOL): fysisk (7 elementer) og psykososiale (13 elementer).
Hvert element er vurdert på en skala fra 0 (verste) til 100 (best), med høyere score som indikerer bedre funksjonsnivåer.
IWQOL-Lite-CT gir sammensatte score for hvert domene, samt en total score, alt fra 0 til 100.
Høyere score gjenspeiler bedre nivåer av funksjon og livskvalitet.
Dette endepunktet viser resultater for 'fysisk funksjonspoeng' og 'total score.'
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Baseline, uke 24
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Endring fra baseline i IWQOL-Lite-CT fysisk funksjonspoeng og total score i uke 48
Tidsramme: Baseline, uke 48
|
IWQOL-Lite-CT er et 20-punkts, overvektsspesifikt Pro-instrument utviklet for bruk i overvekt kliniske studier.
Den vurderer 2 primære domener av overvektrelatert helserelatert livskvalitet (HRQOL): fysisk (7 elementer) og psykososiale (13 elementer).
Hvert element er vurdert på en skala fra 0 (verste) til 100 (best), med høyere score som indikerer bedre funksjonsnivåer.
IWQOL-Lite-CT gir sammensatte score for hvert domene, samt en total score, alt fra 0 til 100.
Høyere score gjenspeiler bedre nivåer av funksjon og livskvalitet.
Dette endepunktet viser resultater for 'fysisk funksjonspoeng' og 'total score.'
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Baseline, uke 48
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Endring fra baseline i IWQOL-Lite-CT fysisk funksjonspoeng og total score i uke 72
Tidsramme: Baseline, uke 72
|
IWQOL-Lite-CT er et 20-punkts, overvektsspesifikt Pro-instrument utviklet for bruk i overvekt kliniske studier.
Den vurderer 2 primære domener av overvektrelatert helserelatert livskvalitet (HRQOL): fysisk (7 elementer) og psykososiale (13 elementer).
Hvert element er vurdert på en skala fra 0 (verste) til 100 (best), med høyere score som indikerer bedre funksjonsnivåer.
IWQOL-Lite-CT gir sammensatte score for hvert domene, samt en total score, alt fra 0 til 100.
Høyere score gjenspeiler bedre nivåer av funksjon og livskvalitet.
Dette endepunktet viser resultater for 'fysisk funksjonspoeng' og 'total score.'
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Baseline, uke 72
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Change From Baseline in Waist Circumference at Week 48
Tidsramme: Baseline, Week 48
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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.
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Baseline, Week 48
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Change From Baseline in Waist Circumference at Week 72
Tidsramme: Baseline, Week 72
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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.
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Baseline, Week 72
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Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48
Tidsramme: Baseline, Week 48
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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.
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Baseline, Week 48
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Change From Baseline in Total Body Fat Mass in kg at Week 72
Tidsramme: Baseline, Week 72
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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.
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Baseline, Week 72
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Percent Change From Baseline for Fat Mass by DXA at Week 48
Tidsramme: Baseline, Week 48
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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.
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Baseline, Week 48
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Percent Change From Baseline for Fat Mass by DXA at Week 72
Tidsramme: Baseline, Week 72
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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.
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Baseline, Week 72
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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
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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.
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Baseline, Week 48
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Change From Baseline in VAT, SAT and Trunk Fat Mass by DXA at Week 72
Tidsramme: Baseline, Week 72
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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.
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Baseline, Week 72
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Percentage of Participants With Reduction in Waist Circumference Greater Than or Equal to (≥) 5 cm at Week 48
Tidsramme: Week 48
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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.
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Week 48
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Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48
Tidsramme: Week 48
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Body weight was measured in kgs to the nearest 0.1 kg.
Only participants with non-missing baseline value were included in analysis.
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Week 48
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Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48
Tidsramme: Week 48
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Only participants with non-missing baseline value were included in analysis.
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Week 48
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Percentage of Participants Achieving Fat Mass ≥ 10% Reduction With <5% Decrease in Lean Mass by DXA at Week 48
Tidsramme: Week 48
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Only participants with non-missing baseline value were included in analysis.
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Week 48
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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
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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.
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Week 48
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Change From Baseline in Body Fat Mass by Bioelectrical Impedance Analysis (BIA) at Week 48
Tidsramme: Baseline, Week 48
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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.
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Baseline, Week 48
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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.
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Baseline, Week 72
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Percent Change From Baseline in Body Fat by BIA at Week 48
Tidsramme: Baseline, Week 48
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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.
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Baseline, Week 48
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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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- 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
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.
Generelle publikasjoner
- Heymsfield SB, Aronne LJ, Montgomery P, Klickstein LB, Coleman LA, Dole K, Mindeholm L, Spruill S, Li X, Attie KM; BELIEVE trial investigators. Bimagrumab plus semaglutide alone or in combination for the treatment of obesity: a randomized phase 2 trial. Nat Med. 2026 Mar;32(3):869-882. doi: 10.1038/s41591-026-04204-0. Epub 2026 Mar 2.
- Moon S, Choi JW, Park JH, Kim DS, Ahn Y, Kim Y, Kong SH, Oh CM. Association of Appendicular Skeletal Muscle Mass Index and Insulin Resistance With Mortality in Multi-Nationwide Cohorts. J Cachexia Sarcopenia Muscle. 2025 Apr;16(2):e13811. doi: 10.1002/jcsm.13811.
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 (Faktiske)
16. november 2022
Primær fullføring (Faktiske)
16. mai 2024
Studiet fullført (Faktiske)
14. juni 2025
Datoer for studieregistrering
Først innsendt
16. oktober 2022
Først innsendt som oppfylte QC-kriteriene
9. november 2022
Først lagt ut (Faktiske)
14. november 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 18828
- VER201-PH2-031 (Annen identifikator: Versanis)
- J4Z-MC-GIDA (Annen identifikator: Eli Lilly and Company)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Anonymiserte individuelle pasientnivådata vil bli gitt i et sikkert tilgangsmiljø ved godkjenning av et forskningsforslag og en signert datadelingsavtale.
IPD-delingstidsramme
Data er tilgjengelig 6 måneder etter den primære publisering og godkjenning av indikasjonen studert i USA og EU, avhengig av hva som er senere.
Data vil være tilgjengelig på ubestemt tid for forespørsel.
Tilgangskriterier for IPD-deling
Et forskningsforslag må godkjennes av et uavhengig granskningspanel og forskere må signere en datadelingsavtale.
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. .