GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

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

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

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI 27-39.9

Primary endpoints

•AUC0-∞,cagri,0.25 milligram (mg)/0.25mg,SD•Cmax,cagri,0.25mg/0.25mg,SD•AUC0-∞,sema,0.25mg/0.25mg,SD

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06716307

Org study IDNN9838-8259

Secondary IDU1111-1309-7476World Health Organization (WHO)

Timeline

Milestones

Study start2024-12-02actual

Study first posted2024-12-04actual

Primary completion2025-03-28actual

Study completion2025-05-22actual

Last update posted2025-08-27actual

Assets

Investigational agents

CagriSema / cagrilintide Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

5 endpoints

Primary/protocol endpoint

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)

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

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)

Cmax

concentration, descriptive

Primary/protocol endpoint

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)

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

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)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Number of adverse events

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

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.