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 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
234
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Novo Nordisk
- Telefonnummer: (+1) 866-867-7178
- E-post: clinicaltrials@novonordisk.com
Studieorter
-
-
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Berlin, Tyskland, 14050
- Rekrytering
- Parexel International GmbH
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Cagrilintide B and Placebo Semaglutide I
Participants will receive Cagrilintide B and Placebo semaglutide I subcutaneously once weekly for up to 17 weeks.
|
Cagrilintide B and placebo semaglutide I will be administered subcutaneously
|
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Experimentell: Cagrilintide D-Injection site 1
Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks.
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Cagrilintide D will be administered subcutaneously.
|
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Experimentell: Cagrilintide D-Injection site 2
Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks.
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Cagrilintide D will be administered subcutaneously.
|
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Experimentell: Cagrilintide D-Injection site 3
Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks.
|
Cagrilintide D will be administered subcutaneously.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
AUC,ss: area under the total cagrilintide concentration-time curve at steady state after 5th dosing of cagrilintide s.c.
Tidsram: Day 113 (pre-dose) to Day 120 (post-dose)
|
Measured in hour nanomoles per litre (h*nmol/L)
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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.
Tidsram: Day 113 (pre-dose) to Day 120 (post-dose)
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Measured in nanomoles per litre (nmol/L).
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Day 113 (pre-dose) to Day 120 (post-dose)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
tmax,ss: time since last dosing to maximum concentration of totala cagrilintide at steady state after 5th dosing of cagrilintide s.c.
Tidsram: 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.
Tidsram: Day 113 (pre-dose) to Day 162 (post-dose)
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Measured in hours.
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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.
Tidsram: Day 113 (pre-dose) to Day 120 (post-dose)
|
Measured in litre.
|
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.
Tidsram: Day 113 (pre-dose) to Day 120 (post-dose)
|
Measured in litre per hours.
|
Day 113 (pre-dose) to Day 120 (post-dose)
|
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AUC,ss: area under the cagrilintide and metabolites concentration-time curve at steady state after the 5th dosing of cagrilintide s.c.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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
Tidsram: 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.
Tidsram: 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.
Tidsram: 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)
|
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Number of treatment-emergent adverse events (TEAEs)
Tidsram: Day 1 (randomisation) to Day 162 (end of study)
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Measured in count of events.
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Day 1 (randomisation) to Day 162 (end of study)
|
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Number of treatment-emergent serious adverse events (TESAEs)
Tidsram: Day 1 (randomisation) to Day 162 (end of study)
|
Measured in count of events.
|
Day 1 (randomisation) to Day 162 (end of study)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
18 maj 2026
Primärt slutförande (Beräknad)
28 maj 2027
Avslutad studie (Beräknad)
1 juni 2027
Studieregistreringsdatum
Först inskickad
21 april 2026
Först inskickad som uppfyllde QC-kriterierna
18 maj 2026
Första postat (Faktisk)
19 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NN9833-8285
- U1111-1314-9337 (Annan identifierare: World Health Organization (WHO))
- 2025-521384-12 (Annan identifierare: European Medical Agency (EMA))
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Ja
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