Clinical trial

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

Recruiting now · Phase 1 · 1 countries · Registry ID NCT07597018

Recruiting nowPhase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 64 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Overweight

Full registry criteria

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.

Treatments and study arms

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

Primary outcomes

AUC,ss: area under the total cagrilintide concentration-time curve at steady state after 5th dosing of cagrilintide s.c.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.Day 113 (pre-dose) to Day 120 (post-dose)

Measured in nanomoles per litre (nmol/L).

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Parexel International GmbH🇩🇪 Berlin, Germany