DelfaGLP-1 Atlas

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Not yet recruitingPhase 1

A Research Study to Compare Blood Levels of Cagrilintide After Multiple Doses of Different Versions of Cagrilintide in Adults With Overweight or Obesity

Bioequivalence Study of Cagrilintide B + Placebo Semaglutide I and Cagrilintide D Once Weekly in Participants With Overweight or Obesity

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

1

Recruiting sites

—

Enrollment

234

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 cagrilintide s.c•Cmax.c

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 IDNCT07597018
Org study IDNN9833-8285
Secondary ID2025-521384-12European Medical Agency (EMA)
Secondary IDU1111-1314-9337World Health Organization (WHO)

Timeline

Milestones

Study start2026-05-18estimated
Study first posted2026-05-19actual
Last update posted2026-05-19actual
Primary completion2027-05-28estimated
Study completion2027-05-28estimated

Assets

Investigational agents

CagriSema / cagrilintideSemaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age64 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Aged 18-64 years (both inclusive) at the time of signing informed consent
•Body mass index (BMI) between 27.0 and 34.9 kilograms per square metre (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
•Considered to be generally healthy 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.

Exclusion criteria

•Previous participation in study(s) with an amylin analogue. Participation is defined as randomisation.
•Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

Endpoints (15)

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

15 endpoints
Primary/protocol endpoint

AUC,ss: area under the total cagrilintide concentration-time curve at steady state after 5th dosing of cagrilintide s.c.

Time frame:Day 113 (pre-dose) to Day 120 (post-dose)

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

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

Time frame:Day 113 (pre-dose) to Day 120 (post-dose)

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax,ss: time since last dosing to maximum concentration of totala cagrilintide at steady state after 5th dosing of cagrilintide s.c.

Time frame:Day 113 (pre-dose) to Day 120 (post-dose)

Tmax

concentration, descriptive

Secondary/protocol endpoint

t½,ss: terminal half-life of total cagrilintide at steady state after 5th dosing of cagrilintide s.c.

Time frame:Day 113 (pre-dose) to Day 162 (post-dose)

Half-life

descriptive

Secondary/protocol endpoint

Vz/F: the apparent volume of distribution of total cagrilintide during elimination after the 5th dosing of cagrilintide s.c.

Time frame:Day 113 (pre-dose) to Day 120 (post-dose)

descriptive

Secondary/protocol endpoint

CL/F: total apparent clearance of total cagrilintide after the 5th dosing of cagrilintide s.c.

Time frame:Day 113 (pre-dose) to Day 120 (post-dose)

descriptive

Secondary/protocol endpoint

AUC,ss: area under the cagrilintide and metabolites concentration-time curve at steady state after the 5th dosing of cagrilintide s.c.

Time frame:Day 113 (pre-dose) to Day 120 (post-dose)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,ss: maximum concentration of cagrilintide and metabolites at steady state after the 5th dosing of cagrilintide s.c.

Time frame:Day 113 (pre-dose) to Day 120 (post-dose)

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax,ss: time since the last dosing to maximum concentration of cagrilintide and metabolites at steady state after the 5th dosing of cagrilintide s.c.

Time frame:Day 113 (pre-dose) to Day 120 (post-dose)

Tmax

descriptive

Secondary/protocol endpoint

t½,ss: terminal half-life of cagrilintide parent at steady state after the 5th dosing of cagrilintide s.c.

Time frame:Day 113 (pre-dose) to Day 120 (post-dose)

Half-life

descriptive

Secondary/protocol endpoint

AUC,ss: area under the total cagrilintide concentration-time curve at steady state after the 4th dosing of cagrilintide s.c

Time frame:Day 22 (pre-dose) to Day 29 (post-dose)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,ss: maximum concentration of total cagrilintide at steady state after the 4th dosing of cagrilintide s.c.

Time frame:Day 22 (pre-dose) to Day 29 (post-dose)

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax,ss: time since the last dosing to maximum concentration of total cagrilintide at steady state after the 4th dosing of cagrilintide s.c.

Time frame:Day 22 (pre-dose) to Day 29 (post-dose)

Tmax

descriptive

Secondary/protocol endpoint

Number of treatment-emergent adverse events (TEAEs)

Time frame:Day 1 (randomisation) to Day 162 (end of study)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of treatment-emergent serious adverse events (TESAEs)

Time frame:Day 1 (randomisation) to Day 162 (end of study)

Serious 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.