A Research Study to Compare Blood Levels of Cagrilintide After Multiple Doses of Different Versions of Cagrilintide in Adults With Overweight or Obesity
- Summary
- 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.
- Short title
- A Research Study to Compare Blood Levels of Cagrilintide After Multiple Doses of Different Versions of Cagrilintide in Adults With Overweight or Obesity
- Official title
- Bioequivalence Study of Cagrilintide B + Placebo Semaglutide I and Cagrilintide D Once Weekly in Participants With Overweight or Obesity
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-06-01
- First posted
- 2026-05-19
- Registry last updated
- 2026-06-26
- Primary completion date
- 2027-05-28
- Start date
- 2026-05-18
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Novo Nordisk A/S
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07597018
- ClinicalTrials.gov ID
- NCT07597018
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
AUC,ss: area under the total cagrilintide concentration-time curve at steady state after 5th dosing of cagrilintide s.c.
Timeframe: Day 113 (pre-dose) to Day 120 (post-dose)
Measured in hour nanomoles per litre (h\*nmol/L)
Cmax,ss: maximum concentration of total cagrilintide at steady state after 5th dosing of cagrilintide s.c.
Timeframe: Day 113 (pre-dose) to Day 120 (post-dose)
Measured in nanomoles per litre (nmol/L).
tmax,ss: time since last dosing to maximum concentration of totala cagrilintide at steady state after 5th dosing of cagrilintide s.c.
Timeframe: Day 113 (pre-dose) to Day 120 (post-dose)
Measured in hours.
t½,ss: terminal half-life of total cagrilintide at steady state after 5th dosing of cagrilintide s.c.
Timeframe: Day 113 (pre-dose) to Day 162 (post-dose)
Measured in hours.
Vz/F: the apparent volume of distribution of total cagrilintide during elimination after the 5th dosing of cagrilintide s.c.
Timeframe: Day 113 (pre-dose) to Day 120 (post-dose)
Measured in litre.
CL/F: total apparent clearance of total cagrilintide after the 5th dosing of cagrilintide s.c.
Timeframe: Day 113 (pre-dose) to Day 120 (post-dose)
Measured in litre per hours.
AUC,ss: area under the cagrilintide and metabolites concentration-time curve at steady state after the 5th dosing of cagrilintide s.c.
Timeframe: Day 113 (pre-dose) to Day 120 (post-dose)
Measured in hours\*nmol/L.
Cmax,ss: maximum concentration of cagrilintide and metabolites at steady state after the 5th dosing of cagrilintide s.c.
Timeframe: Day 113 (pre-dose) to Day 120 (post-dose)
Measured in nmol/L.
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.
Timeframe: Day 113 (pre-dose) to Day 120 (post-dose)
Measured in hours.
t½,ss: terminal half-life of cagrilintide parent at steady state after the 5th dosing of cagrilintide s.c.
Timeframe: Day 113 (pre-dose) to Day 120 (post-dose)
Measured in hours.
AUC,ss: area under the total cagrilintide concentration-time curve at steady state after the 4th dosing of cagrilintide s.c
Timeframe: Day 22 (pre-dose) to Day 29 (post-dose)
Measured in hours\*nmol/L.
Cmax,ss: maximum concentration of total cagrilintide at steady state after the 4th dosing of cagrilintide s.c.
Timeframe: Day 22 (pre-dose) to Day 29 (post-dose)
Measured in nmol/L.
tmax,ss: time since the last dosing to maximum concentration of total cagrilintide at steady state after the 4th dosing of cagrilintide s.c.
Timeframe: Day 22 (pre-dose) to Day 29 (post-dose)
Measured in hours.
Number of treatment-emergent adverse events (TEAEs)
Timeframe: Day 1 (randomisation) to Day 162 (end of study)
Measured in count of events.
Number of treatment-emergent serious adverse events (TESAEs)
Timeframe: Day 1 (randomisation) to Day 162 (end of study)
Measured in count of events.
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 64 Years
- Healthy volunteers
- No
- 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.
- 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.
- Parexel International GmbHBerlin, GermanyRecruiting
- 2025
- 2025-521384-12
- U1111-1314-9337
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Obesity disorder Primary condition