DRUG
CagriSema (cagrilintide B and semaglutide I)
Cagrilintide and semaglutide will be administered subcutaneously using DV3384 pen-injector.
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
Status
Completed
Phase
Phase 1
Enrollment
18
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
CagriSema A
Cagrilintide and semaglutide will be administered subcutaneously using PDS290 pen-injector.
Timeline
From registration to results.
First posted
Dec 4, 2024
Study start
Dec 2, 2024
Primary completion
Mar 28, 2025
Study completion
May 22, 2025
Results posted
Not reported
Registry updated
Aug 27, 2025
Outcomes
What the study measures.
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
Time frame · From 0 hours (pre-dose) to 1176 hours (post-dose)
Measured in hours\*nanomoles per liter (h\*nmol/L).
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
Time frame · From 0 hours (pre-dose) to 1176 hours (post-dose)
Measured in nanomoles per liter (nmol/L).
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
Time frame · From 0 hours (pre-dose) to 1176 hours (post-dose)
Measured in h\*nmol/L.
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
Time frame · From 0 hours (pre-dose) to 1176 hours (post-dose)
Measured in nmol/L.
Secondary outcomes
Number of adverse events
Time frame · From first investigational medicinal product (IMP) administration (Day 1) to the end of study visit (Day 99)
Measured as number of events.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 64 Years
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Celerion, Lincoln
Lincoln, Nebraska, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Cagrilintide.
NCT IDStudyPhase / statusEnrollmentUpdated
A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight
Novo Nordisk · Obesity · Type 2 Diabetes
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2026-07
A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term
Novo Nordisk · Obesity
Phase 3
Active, not recruiting
609
2026-07
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight
Novo Nordisk · Obesity
Phase 3
Active, not recruiting
3,400
2026-07
REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels
Novo Nordisk · Cardiovascular Disease
Phase 3
Active, not recruiting
7,101
2026-07
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both
Novo Nordisk · Diabetes Mellitus, Type 2
Phase 3
Completed
1,023
2026-07
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
Novo Nordisk · Overweight · Obesity
Phase 3
Recruiting
460
2026-07
A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes
Novo Nordisk · Diabetes Mellitus, Type 2
Phase 2
Withdrawn
0
2026-07
A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight
Novo Nordisk · Overweight · Obesity
Phase 3
Withdrawn
0
2026-07
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Put the record in context.
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