About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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/m²) (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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Cagrilintide D
DrugCagrilintide D will be administered subcutaneously.
Cagrilintide B and placebo semaglutide I
DrugCagrilintide B and placebo semaglutide I will be administered subcutaneously
Treatment groups
Trial outcomes
Primary outcomes
AUC,ss: area under the total cagrilintide concentration-time curve at steady state after 5th dosing of cagrilintide s.c.
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.
Measured in nanomoles per litre (nmol/L).
Secondary outcomes
tmax,ss: time since last dosing to maximum concentration of totala cagrilintide at steady state after 5th dosing of cagrilintide s.c.
Measured in hours.
t½,ss: terminal half-life of total cagrilintide at steady state after 5th dosing of cagrilintide s.c.
Measured in hours.
Vz/F: the apparent volume of distribution of total cagrilintide during elimination after the 5th dosing of cagrilintide s.c.
Measured in litre.
CL/F: total apparent clearance of total cagrilintide after the 5th dosing of cagrilintide s.c.
Measured in litre per hours.
Sponsors and contacts
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