A Research Study to Compare Blood Levels of Cagrilintide After Multiple Doses of Different Versions of Cagrilintide in Adults With Overweight or Obesity
23. juni 2026 oppdatert av: Novo Nordisk A/S
Bioequivalence Study of Cagrilintide B + Placebo Semaglutide I and Cagrilintide D Once Weekly in Participants With Overweight or Obesity
This clinical study is testing two versions of the study medicine cagrilintide.
The purpose of the study is to compare these two versions to understand their effects in participants with overweight or obesity.
Participants will receive either cagrilintide version D or cagrilintide version B, and which treatment participants receive is decided by chance.
Participants will be in this clinical study for about 6 months.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
234
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Novo Nordisk
- Telefonnummer: (+1) 866-867-7178
- E-post: clinicaltrials@novonordisk.com
Studiesteder
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-
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Berlin, Tyskland, 14050
- Rekruttering
- Parexel International GmbH
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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
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Aged 18-64 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 27.0 and 34.9 kilograms per square metre (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion Criteria:
- Previous participation in study(s) with an amylin analogue. Participation is defined as randomisation.
- Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Cagrilintide B and Placebo Semaglutide I
Participants will receive Cagrilintide B and Placebo semaglutide I subcutaneously once weekly for up to 17 weeks.
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Cagrilintide B and placebo semaglutide I will be administered subcutaneously
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Eksperimentell: Cagrilintide D-Injection site 1
Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks.
|
Cagrilintide D will be administered subcutaneously.
|
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Eksperimentell: Cagrilintide D-Injection site 2
Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks.
|
Cagrilintide D will be administered subcutaneously.
|
|
Eksperimentell: Cagrilintide D-Injection site 3
Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks.
|
Cagrilintide D will be administered subcutaneously.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
AUC,ss: area under the total cagrilintide concentration-time curve at steady state after 5th dosing of cagrilintide s.c.
Tidsramme: Day 113 (pre-dose) to Day 120 (post-dose)
|
Measured in hour nanomoles per litre (h*nmol/L)
|
Day 113 (pre-dose) to Day 120 (post-dose)
|
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Cmax,ss: maximum concentration of total cagrilintide at steady state after 5th dosing of cagrilintide s.c.
Tidsramme: Day 113 (pre-dose) to Day 120 (post-dose)
|
Measured in nanomoles per litre (nmol/L).
|
Day 113 (pre-dose) to Day 120 (post-dose)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
tmax,ss: time since last dosing to maximum concentration of totala cagrilintide at steady state after 5th dosing of cagrilintide s.c.
Tidsramme: Day 113 (pre-dose) to Day 120 (post-dose)
|
Measured in hours.
|
Day 113 (pre-dose) to Day 120 (post-dose)
|
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t½,ss: terminal half-life of total cagrilintide at steady state after 5th dosing of cagrilintide s.c.
Tidsramme: Day 113 (pre-dose) to Day 162 (post-dose)
|
Measured in hours.
|
Day 113 (pre-dose) to Day 162 (post-dose)
|
|
Vz/F: the apparent volume of distribution of total cagrilintide during elimination after the 5th dosing of cagrilintide s.c.
Tidsramme: Day 113 (pre-dose) to Day 120 (post-dose)
|
Measured in litre.
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Day 113 (pre-dose) to Day 120 (post-dose)
|
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CL/F: total apparent clearance of total cagrilintide after the 5th dosing of cagrilintide s.c.
Tidsramme: Day 113 (pre-dose) to Day 120 (post-dose)
|
Measured in litre per hours.
|
Day 113 (pre-dose) to Day 120 (post-dose)
|
|
AUC,ss: area under the cagrilintide and metabolites concentration-time curve at steady state after the 5th dosing of cagrilintide s.c.
Tidsramme: Day 113 (pre-dose) to Day 120 (post-dose)
|
Measured in hours*nmol/L.
|
Day 113 (pre-dose) to Day 120 (post-dose)
|
|
Cmax,ss: maximum concentration of cagrilintide and metabolites at steady state after the 5th dosing of cagrilintide s.c.
Tidsramme: Day 113 (pre-dose) to Day 120 (post-dose)
|
Measured in nmol/L.
|
Day 113 (pre-dose) to Day 120 (post-dose)
|
|
tmax,ss: time since the last dosing to maximum concentration of cagrilintide and metabolites at steady state after the 5th dosing of cagrilintide s.c.
Tidsramme: Day 113 (pre-dose) to Day 120 (post-dose)
|
Measured in hours.
|
Day 113 (pre-dose) to Day 120 (post-dose)
|
|
t½,ss: terminal half-life of cagrilintide parent at steady state after the 5th dosing of cagrilintide s.c.
Tidsramme: Day 113 (pre-dose) to Day 120 (post-dose)
|
Measured in hours.
|
Day 113 (pre-dose) to Day 120 (post-dose)
|
|
AUC,ss: area under the total cagrilintide concentration-time curve at steady state after the 4th dosing of cagrilintide s.c
Tidsramme: Day 22 (pre-dose) to Day 29 (post-dose)
|
Measured in hours*nmol/L.
|
Day 22 (pre-dose) to Day 29 (post-dose)
|
|
Cmax,ss: maximum concentration of total cagrilintide at steady state after the 4th dosing of cagrilintide s.c.
Tidsramme: Day 22 (pre-dose) to Day 29 (post-dose)
|
Measured in nmol/L.
|
Day 22 (pre-dose) to Day 29 (post-dose)
|
|
tmax,ss: time since the last dosing to maximum concentration of total cagrilintide at steady state after the 4th dosing of cagrilintide s.c.
Tidsramme: Day 22 (pre-dose) to Day 29 (post-dose)
|
Measured in hours.
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Day 22 (pre-dose) to Day 29 (post-dose)
|
|
Number of treatment-emergent adverse events (TEAEs)
Tidsramme: Day 1 (randomisation) to Day 162 (end of study)
|
Measured in count of events.
|
Day 1 (randomisation) to Day 162 (end of study)
|
|
Number of treatment-emergent serious adverse events (TESAEs)
Tidsramme: Day 1 (randomisation) to Day 162 (end of study)
|
Measured in count of events.
|
Day 1 (randomisation) to Day 162 (end of study)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Clinical Transparency (dept. 2834), Novo Nordisk A/S
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)
18. mai 2026
Primær fullføring (Antatt)
28. mai 2027
Studiet fullført (Antatt)
1. juni 2027
Datoer for studieregistrering
Først innsendt
21. april 2026
Først innsendt som oppfylte QC-kriteriene
18. mai 2026
Først lagt ut (Faktiske)
19. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NN9833-8285
- U1111-1314-9337 (Annen identifikator: World Health Organization (WHO))
- 2025-521384-12 (Annen identifikator: European Medical Agency (EMA))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Ja
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