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Not yet recruitingPhase 1

A Research Study to Compare Blood Levels of Two Different Versions of Cagrilintide in Adults With Excess Body Weight

Investigation of Pharmacokinetics of Two Different Presentations of Cagrilintide in Participants With Overweight and Obesity

Lead sponsor

Novo Nordisk A/S

Asset

CagriSema / cagrilintide

Subcutaneous · GLP-1 / amylin

Listed sites

1

Recruiting sites

Enrollment

50

estimated

Study population

Obesity / overweight

Key I/E criterion

BMI 27-34.9

Primary endpoints

AUC of total cagrilintide at steady state after 5th dosing of cagrilintideCmax

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 IDNCT07605052
Org study IDNN9833-8819
Secondary IDU1111-1336-5994World Health Organization (WHO)

Timeline

Milestones

Study start2026-05-20estimated
Study first posted2026-05-22actual
Last update posted2026-05-22actual
Primary completion2026-09-03estimated
Study completion2026-09-03estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age64 Years
SexAll
Healthy volunteersNot accepted

Eligibility criteria

Key Inclusion Criteria:

Age 18-64 years (both inclusive) at the time of signing informed consent.
Male or female (sex assigned at birth).
Body mass index (BMI) between 27.0 and 34.9 kilogram per meter square (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 (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Key Exclusion Criteria:

Previous dosing of marketed or non-marketed amylin-agonists (a).
Any condition, unwillingness or inability which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol (a).

1. As declared by the participant, reported in the medical records or at the investigator's discretion.

Endpoints (6)

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

6 endpoints
Primary/protocol endpoint

AUCss: area under the total cagrilintide concentration-time curve at steady state after 5th dosing of cagrilintide

Time frame:From Pre-dose at Day 29 to Day 36

concentration, descriptive

Primary/protocol endpoint

Cmax,ss: maximum observed concentration of total cagrilintide at steady state after 5th dosing of cagrilintide

Time frame:From Pre-dose at Day 29 to Day 36

concentration, descriptive

Secondary/protocol endpoint

AUCss: area under the total cagrilintide concentration-time curve at steady state after 4th dosing of cagrilintide

Time frame:From Pre-dose at Day 22 to Day 29

concentration, descriptive

Secondary/protocol endpoint

Cmax,ss: maximum observed concentration of total cagrilintide at steady state after 4th dosing of cagrilintide

Time frame:From Pre-dose at Day 22 to Day 29

concentration, descriptive

Secondary/protocol endpoint

AUCss: area under the total cagrilintide concentration-time curve at steady state after 1st dosing of cagrilintide

Time frame:From Pre-dose at Day 1 to Day 8

concentration, descriptive

Secondary/protocol endpoint

Cmax,ss: maximum observed concentration of total cagrilintide at steady state after 1st dosing of cagrilintide

Time frame:From Pre-dose at Day 1 to Day 8

concentration, descriptive

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.