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A Research Study to Compare Blood Levels of Cagrilintide After Multiple Doses of Different Versions of Cagrilintide in Adults With Overweight or Obesity

18. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

234

Fase

  • Fase 1

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Tyskland
      • Berlin, Tyskland, 14050
        • Parexel International GmbH

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

  • Voksen

Tager imod sunde frivillige

Ingen

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

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cagrilintide B and Placebo Semaglutide I
Participants will receive Cagrilintide B and Placebo semaglutide I subcutaneously once weekly for up to 17 weeks.
Medicin: Cagrilintide B and placebo semaglutide I
Cagrilintide B and placebo semaglutide I will be administered subcutaneously
Eksperimentel: Cagrilintide D-Injection site 1
Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks.
Medicin: Cagrilintide D
Cagrilintide D will be administered subcutaneously.
Eksperimentel: Cagrilintide D-Injection site 2
Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks.
Medicin: Cagrilintide D
Cagrilintide D will be administered subcutaneously.
Eksperimentel: Cagrilintide D-Injection site 3
Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks.
Medicin: Cagrilintide D
Cagrilintide D will be administered subcutaneously.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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)
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
Foranstaltningsbeskrivelse
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)
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.
Day 113 (pre-dose) to Day 120 (post-dose)
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.
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)

Samarbejdspartnere og efterforskere

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

Sponsor

Novo Nordisk A/S

Efterforskere

  • Studieleder: Clinical Transparency (dept. 2834), Novo Nordisk A/S

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)

18. maj 2026

Primær færdiggørelse (Anslået)

28. maj 2027

Studieafslutning (Anslået)

28. maj 2027

Datoer for studieregistrering

Først indsendt

21. april 2026

Først indsendt, der opfyldte QC-kriterier

18. maj 2026

Først opslået (Faktiske)

19. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NN9833-8285
  • U1111-1314-9337 (Anden identifikator: World Health Organization (WHO))
  • 2025-521384-12 (Anden identifikator: European Medical Agency (EMA))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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 Cagrilintide B and placebo semaglutide I

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