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

NCT06716307 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9838-8259U1111-1309-7476
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (4)

• 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

  Measured in hours\*nanomoles per liter (h\*nmol/L).

  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

  Measured in nanomoles per liter (nmol/L).

  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

  Measured in h\*nmol/L.

  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

  Measured in nmol/L.

  From 0 hours (pre-dose) to 1176 hours (post-dose)

Secondary Outcomes (1)

• Number of adverse events

  From first investigational medicinal product (IMP) administration (Day 1) to the end of study visit (Day 99)

Study Arms (2)

Treatment sequence 1

EXPERIMENTAL

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.

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

Treatment sequence 2

EXPERIMENTAL

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.

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

Interventions

CagriSema (cagrilintide B and semaglutide I) DRUG

Cagrilintide and semaglutide will be administered subcutaneously using DV3384 pen-injector.

Treatment sequence 1; Treatment sequence 2

CagriSema A DRUG

Cagrilintide and semaglutide will be administered subcutaneously using PDS290 pen-injector.

Treatment sequence 1; Treatment sequence 2

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Celerion, Lincoln

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: December 2, 2024
• Primary Completion: March 28, 2025
• Study Completion: May 22, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)