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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: CagriSema (cagrilintide B and semaglutide I); Drug: CagriSema A

Study type: Interventional

Funder types: Industry

Identifiers

NCT06716307

NN9838-8259

U1111-1309-7476 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Treatment sequence 1

Experimental group

Description:

Participants will receive a single subcutaneous (s.c.) dose of CagriSema (cagrilintide B and semaglutide I) in DV3384 pen-injector in period 1 followed by a single s.c. dose of CagriSema A in PDS290 pen-injector in period 2 separated by a wash out period of minimum 7 weeks.

Treatment:

Drug: CagriSema A

Drug: CagriSema (cagrilintide B and semaglutide I)

Treatment sequence 2

Experimental group

Description:

Participants will receive a single s.c. dose of CagriSema A in PDS290 pen-injector in period 1 followed by a single s.c. dose of CagriSema (cagrilintide B and semaglutide I) in DV3384 pen-injector in period 2 separated by a wash out period of minimum 7 weeks.

Treatment:

Drug: CagriSema A

Drug: CagriSema (cagrilintide B and semaglutide I)