GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Japanese Men

Investigation of Safety, Tolerability and Pharmacokinetics of Subcutaneously Co-administered Single Doses of NNC0480-0389 and Semaglutide in Healthy Japanese Male Subjects

Lead sponsor

Novo Nordisk A/S

Assets

NNC0480-0389 / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 20-24.9•Male•Healthy volunteers

Primary endpoint

•Treatment-emergent AEs (any)

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 IDNCT04878406

Org study IDNN9389-4680

Secondary IDU1111-1263-7182World Health Organization (WHO)

Timeline

Milestones

Study first posted2021-05-07actual

Study start2021-05-18actual

Primary completion2021-07-20actual

Study completion2021-07-20actual

Last update posted2023-05-17actual

Assets

Investigational agents

NNC0480-0389 Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age20 Years

Maximum age55 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Male aged 20-55 years (both inclusive) at the time of signing the informed consent.

•Both parents of Japanese descent.

•Body mass index between 20.0 kg/m^2 and 24.9 kg/m^2 (both inclusive).

•Considered to be generally healthy 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

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

•Glycated haemoglobin (HbA1c) greater 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 acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation within 14 days prior to the day of screening.

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

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

Number of treatment emergent adverse events (TEAEs)

Time frame:From time of dosing (day 1) until completion of the follow-up visit (day 43)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

AUC0-∞,NNC0480-0389,SD: Area under the NNC0480-0389 plasma concentration-time curve from time 0 to infinity upon a single-dose

Time frame:From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)

Cmax

concentration, descriptive

Secondary/protocol endpoint

AUC0-∞,semaglutide,SD: Area under the semaglutide plasma concentration-time curve from time 0 to infinity upon a single-dose

Time frame:From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,semaglutide,SD: Maximum plasma concentration of semaglutide upon a single-dose

Time frame:From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)

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.