GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Combined Versus Separate Injections in People With Overweight or Obesity

Investigation of Pharmacokinetics Following Co-administration of Cagrilintide (NNC0174-0833) and Semaglutide Versus Separate Injections in Subjects 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

•AUC0-168h,cagri,2.4/2.4mg,SS AUC of cagrilintide during a dosing interval•Cmax,cagri,2.4/2.4mg,SS Cmax.4 mg in combination with semaglutide 2.4 mg•AUC0-168h,sema,2.4/2.4mg,SS AUC of semaglutide during a dosing interval

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 IDNCT04940078

Org study IDNN9838-4614

Secondary IDU1111-1250-7789World Health Organization (WHO)

Timeline

Milestones

Study first posted2021-06-25actual

Study start2021-07-07actual

Primary completion2022-01-19actual

Study completion2022-02-16actual

Last update posted2025-12-12actual

Assets

Investigational agents

CagriSema / cagrilintide Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female of non-childbearing potential (NCBP)

•Aged 18-55 years (both inclusive) at the time of signing informed consent

•Body mass index (BMI) between 27.0 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator

Exclusion criteria

•Previous participation in trial(s) with an amylin analogue unless documented that the subject was assigned to placebo treatment. Participation is defined as randomisation

•Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol

Endpoints (12)

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

12 endpoints

Primary/protocol endpoint

AUC0-168h,cagri,2.4/2.4mg,SS area under the cagrilintide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dosing of cagrilintide 2.4 mg in combination with semaglutide 2.4 mg

Time frame:Day 148 (pre-dose) to Day 155 (168 hours post-dose)

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Cmax,cagri,2.4/2.4mg,SS maximum concentration of cagrilintide at steady state after last dosing of cagrilintide 2.4 mg in combination with semaglutide 2.4 mg

Time frame:Day 148 (pre-dose) to Day 155 (168 hours post-dose)

Cmax

concentration, descriptive

Primary/protocol endpoint

AUC0-168h,sema,2.4/2.4mg,SS area under the semaglutide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dosing of semaglutide 2.4 mg in combination with cagrilintide 2.4 mg

Time frame:Day 148 (pre-dose) to Day 155 (168 hours post-dose)

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Cmax,sema,2.4/2.4mg,SS maximum concentration of semaglutide at steady state after last dosing of semaglutide 2.4 mg in combination with cagrilintide 2.4 mg

Time frame:Day 148 (pre-dose) to Day 155 (168 hours post-dose)

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax,cagri,2.4/2.4mg,SS time since last dosing to maximum concentration of cagrilintide at steady state after last dosing of cagrilintide 2.4 mg in combination with semaglutide 2.4 mg

Time frame:Day 148 (pre-dose) to Day 155 (168 hours post-dose)

Tmax

descriptive

Secondary/protocol endpoint

t½,cagri,2.4/2.4mg,SS terminal half-life of cagrilintide at steady state after last dosing of cagrilintide 2.4 mg in combination with semaglutide 2.4 mg

Time frame:Day 148 (pre-dose) to Day 186 (912 hours post-dose)

Half-life

descriptive

Secondary/protocol endpoint

tmax,sema,2.4/2.4mg,SS time since last dosing to maximum concentration of semaglutide at steady state after last dosing of semaglutide 2.4 mg in combination with cagrilintide 2.4 mg

Time frame:Day 148 (pre-dose) to Day 155 (168 hours post-dose)

Tmax

concentration, descriptive

Secondary/protocol endpoint

t½,sema,2.4/2.4mg,SS terminal half-life of semaglutide at steady state after last dosing of semaglutide 2.4 mg in combination with cagrilintide 2.4 mg

Time frame:Day 148 (pre-dose) to Day 186 (912 hours post-dose)

Half-life

descriptive

Secondary/protocol endpoint

AUC0-168h,cagri,1.7/1.7mg,SS area under the cagrilintide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dose of cagrilintide 1.7 mg in combination with semaglutide 1.7 mg

Time frame:Day 120 (pre-dose) to Day 127 (168 hours post-dose)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

AUC0-168h,sema,1.7/1.7mg,SS area under the semaglutide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dose of semaglutide 1.7 mg in combination with cagrilintide 1.7 mg

Time frame:Day 120 (pre-dose) to Day 127 (168 hours post-dose)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

PART A: Number of treatment emergent adverse events

Time frame:From time of dosing (Day 1) to follow-up (Day 186)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

PART B: Number of treatment emergent adverse events

Time frame:From time of dosing (Day 1) to follow-up (Day 29)

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.