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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorNovo Nordisk A/S

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Cagrilintide D

    Drug

    Cagrilintide D will be administered subcutaneously.

  • Cagrilintide B and placebo semaglutide I

    Drug

    Cagrilintide B and placebo semaglutide I will be administered subcutaneously

Treatment groups

234 Participants
are divided into 4 treatment groups
Group A: Cagrilintide B and Placebo Semaglutide IExperimental treatment 1 intervention
Group B: Cagrilintide D-Injection site 1Experimental treatment 1 intervention
Group C: Cagrilintide D-Injection site 2Experimental treatment 1 intervention
Group D: Cagrilintide D-Injection site 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Day 113 (pre-dose) to Day 120 (post-dose)
2

Cmax,ss: maximum concentration of total cagrilintide at steady state after 5th dosing of cagrilintide s.c.

Measured in nanomoles per litre (nmol/L).

Time frame
Day 113 (pre-dose) to Day 120 (post-dose)

Secondary outcomes

1

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.

Time frame
Day 113 (pre-dose) to Day 120 (post-dose)
2

t½,ss: terminal half-life of total cagrilintide at steady state after 5th dosing of cagrilintide s.c.

Measured in hours.

Time frame
Day 113 (pre-dose) to Day 162 (post-dose)
3

Vz/F: the apparent volume of distribution of total cagrilintide during elimination after the 5th dosing of cagrilintide s.c.

Measured in litre.

Time frame
Day 113 (pre-dose) to Day 120 (post-dose)
4

CL/F: total apparent clearance of total cagrilintide after the 5th dosing of cagrilintide s.c.

Measured in litre per hours.

Time frame
Day 113 (pre-dose) to Day 120 (post-dose)

Other outcomes

Sponsors and contacts

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