GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People

A Study to Investigate the Pharmacokinetics of Semaglutide and NNC0480-0389 When Subcutaneously Administered as a Co-formulation or as Separate Injections in Healthy Participants

Lead sponsor

Novo Nordisk A/S

Assets

NNC0480-0389 / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criterion

•BMI 20-29.9

Primary endpoints

•AUC0-∞,sema,SD•AUC0-∞,NNC0480-0389,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 IDNCT05046873

Org study IDNN9389-4679

Secondary ID2021-001397-36

Secondary IDU1111-1266-0502World Health Organization (WHO)

Timeline

Milestones

Study start2021-09-06actual

Study first posted2021-09-16actual

Primary completion2022-01-05actual

Study completion2022-01-05actual

Last update posted2023-07-03actual

Assets

Investigational agents

NNC0480-0389 Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

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 20.0 and 29.9 kg/m^2 (both inclusive).

Exclusion criteria

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

•Glycosylated haemoglobin (HbA1c) more than or equal to 6.5 % (48 mmol/mol) at screening.

•Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation within 14 days before screening.

•Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.

Endpoints (4)

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

4 endpoints

Primary/protocol endpoint

AUC0-∞,sema,SD: Area under the semaglutide plasma concentration-time curve after a single dose

Time frame:From baseline (visit 2/12, day 1, pre-dose) until completion of the assessment period (visit 11/21, day 36)

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

AUC0-∞,NNC0480-0389,SD: Area under the NNC0480-0389 plasma concentration-time curve after a single dose

Time frame:From baseline (visit 2/12, day 1, pre-dose) until completion of the assessment period (visit 11/21, day 36)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,sema,SD: Maximum plasma concentration of semaglutide after a single dose

Time frame:From baseline (visit 2/12, day 1, pre-dose) until completion of the assessment period (visit 11/21, day 36)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Cmax,NNC0480-0389,SD: Maximum plasma concentration of NNC0480-0389 after a single dose

Time frame:From baseline (visit 2/12, day 1, pre-dose) until completion of the assessment period (visit 11/21, day 36)

Cmax

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.