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

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
Novo Nordisk A/S
Study ID
NCT06716307
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • CagriSema (cagrilintide B and semaglutide I) — DRUG
    Cagrilintide and semaglutide will be administered subcutaneously using DV3384 pen-injector.
  • CagriSema A — DRUG
    Cagrilintide and semaglutide will be administered subcutaneously using PDS290 pen-injector.

Study Details

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.

Key Dates

Start date
Dec 2, 2024
Status verified
Aug 2025
Primary completion
Mar 28, 2025
Completion
May 22, 2025

Study Design

Enrollment
18 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment sequence 1
    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.
  • Experimental: Treatment sequence 2
    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.

Primary Outcome 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 [ Time Frame: From 0 hours (pre-dose) to 1176 hours (post-dose) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Celerion, LincolnLincolnNebraska68502-

Find similar trials in Lincoln, NE

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Celerion, Lincoln· Lincoln, NE

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