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

Registration

Registration

NCT06716307

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

NONE

Status

COMPLETED

Enrollment

18

Start

2024-12-02

Primary completion

2025-03-28

Lead sponsor

Novo Nordisk A/S

Conditions

Obesity

Interventions

DRUG:CagriSema (cagrilintide B and semaglutide I); DRUG:CagriSema A

Results posted

FALSE

Individual participant data sharing

YES

Secondary identifiers

OTHER:U1111-1309-7476

Registered primary outcomes

• 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 [From 0 hours (pre-dose) to 1176 hours (post-dose)]
• 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 [From 0 hours (pre-dose) to 1176 hours (post-dose)]
• 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 [From 0 hours (pre-dose) to 1176 hours (post-dose)]
• 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 [From 0 hours (pre-dose) to 1176 hours (post-dose)]