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Completed
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
Conditions: Obesity
Sex: All
Ages: 18 Years – 64 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 18
Sponsor: Novo Nordisk A/S
Location: Celerion, Lincoln Lincoln Nebraska
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.
Source: ClinicalTrials.gov (NCT06716307). StuddyBuddy aggregates publicly available trial information.