CompletedPhase 1

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

Investigation of Pharmacokinetic Properties of Subcutaneously co Administered Single Doses of NNC0480-0389 and Semaglutide in Healthy Chinese Male Subjects

Lead sponsor

Novo Nordisk A/S

Assets

NNC0480-0389 / Semaglutide

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers

Eligibility highlights

•BMI 20-27.9•Male•Healthy volunteers

Primary endpoints

•AUC0-∞,NNC0480-0389,SD AUC of NNC0480-0389 from time 0 to infinity after•Cmax,NNC0480-0389,SD Cmax

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05498610

Org study IDNN9389-4774

Secondary IDU1111-1264-4516World Health Organization (WHO)

Timeline

Milestones

Study start2022-08-11actual

Study first posted2022-08-12actual

Primary completion2022-10-12actual

Study completion2022-10-12actual

Last update posted2023-12-26actual

Assets

Investigational agents

NNC0480-0389 Semaglutide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Chinese male participants aged 18-55 years (both inclusive) at the time of signing informed consent.

•Body mass index (BMI) between 20.0 kg/m^2 and 27.9 kg/m^2 (both inclusive).

•Body weight equal to or greather than 54.0 kg.

•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 participant's safety or compliance with the protocol.

•Glycated haemoglobin (HbA1c) geather han or equal to 6.5 % (48 mmol/mol) at screening.

•Use of prescription medicinal products or non-prescription drugs (including Chinese traditional medicine or local medicine), 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-∞,NNC0480-0389,SD Area under the NNC0480-0389 plasma concentration-time curve from time 0 to infinity after a single dose (SD)

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

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Cmax,NNC0480-0389,SD Maximum plasma concentration of NNC0480-0389 after 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-∞,sema,SD Area under the semaglutide plasma concentration-time curve from time 0 to infinity after 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,sema,SD The maximum plasma concentration of semaglutide after 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 6, 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 6, 2026 snapshot.