Clinical trial NCT06716307: A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Single Doses of Different Versions of Injectable CagriSema in Adults With Overweight or Obesity
Official title: Comparing the Pharmacokinetics of Cagrilintide and Semaglutide Following Single Subcutaneous Doses of Different CagriSema Presentations, in a Crossover Manner in Adult Participants With Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-12-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will compare the blood levels of cagrilintide and semaglutide when the same dose is given in two different versions of CagriSema. CagriSema is a medicine that combines two medicines called cagrilintide and semaglutide. It is still being tested in studies and is not yet available for doctors to prescribe. Participants will get an injection with each of the two versions of CagriSema at two different times at the clinic. Like all medicines, the study medicine may have side effects. The study will last for about 18 weeks.


Eligibility criteria: Inclusion criteria:

* Male or female.
* Aged 18-64 years (both inclusive) at the time of signing informed consent.
* Body Mass Index (BMI) between 27.0 and 39.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening.

Overweight should be due to excess adipose tissue, as judged by the investigator.

- Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion criteria:

* Known or suspected hypersensitivity to study intervention(s) or related products.
* Previous dosing with an amylin analogue.
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
* Glycosylated haemoglobin (HbA1c) greater than or equal to (\>=) 6.5 percent (48 millimoles per mole \[mmol/mol\]) at screening.

Primary outcomes:
measure: AUC0-∞,cagri,0.25 milligram (mg)/0.25mg,SD: Area under the cagrilintide concentration-time curve after a single dose 0.25 mg/0.25 mg CagriSema A in PDS290 pen-injector or CagriSema in DV3384 pen-injector
timeFrame: From 0 hours (pre-dose) to 1176 hours (post-dose)
measure: Cmax,cagri,0.25mg/0.25mg,SD: Maximum concentration of cagrilintide after a single dose 0.25 mg/0.25 mg CagriSema A in PDS290 pen-injector or CagriSema in DV3384 pen-injector
timeFrame: From 0 hours (pre-dose) to 1176 hours (post-dose)
measure: AUC0-∞,sema,0.25mg/0.25mg,SD: Area under the semaglutide concentration-time curve after a single dose 0.25 mg/0.25 mg CagriSema A in PDS290 pen-injector or CagriSema in DV3384 pen-injector
timeFrame: From 0 hours (pre-dose) to 1176 hours (post-dose)
measure: Cmax,sema,0.25mg/0.25mg,SD: Maximum concentration of semaglutide after a single dose 0.25 mg/0.25 mg CagriSema A in PDS290 pen-injector or CagriSema in DV3384 pen-injector
timeFrame: From 0 hours (pre-dose) to 1176 hours (post-dose)
Secondary outcomes:
measure: Number of adverse events
timeFrame: From first investigational medicinal product (IMP) administration (Day 1) to the end of study visit (Day 99)
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion, Lincoln
state: Nebraska
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: