DRUG
Cagrilintide D
Cagrilintide D will be administered subcutaneously.
Status
Recruiting
Phase
Phase 1
Enrollment
234
Locations
1
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
Cagrilintide D will be administered subcutaneously.
DRUG
Cagrilintide B and placebo semaglutide I will be administered subcutaneously
Timeline
First posted
May 19, 2026
Study start
May 18, 2026
Primary completion
May 28, 2027
Study completion
Jun 1, 2027
Results posted
Not reported
Registry updated
Jun 26, 2026
Outcomes
AUC,ss: area under the total cagrilintide concentration-time curve at steady state after 5th dosing of cagrilintide s.c.
Time frame · 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.
Time frame · 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.
Time frame · 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.
Time frame · 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.
Time frame · 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.
Time frame · 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.
Time frame · 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.
Time frame · 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.
Time frame · 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.
Time frame · 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
Time frame · 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.
Time frame · Day 22 (pre-dose) to Day 29 (post-dose)
Measured in nmol/L.
Eligibility
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.
Study locations
Germany. Showing up to 24 locations stored in the fast local snapshot.
Parexel International GmbH
Berlin, Germany
Publications
No PMID-linked publications were present in this registry snapshot.
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