GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT05742919

CompletedPhase 1

A Research Study Looking at How a Single Dose of the Medicine NNC0194-0499 Behaves in Chinese Men

Investigation of Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0194-0499 in Chinese Males

Lead sponsor

Novo Nordisk A/S

Asset

NNC0194-0499

Subcutaneous · FGF21 analog

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 23-34.9•Male

Primary endpoint

•AUC0-∞, NNC0194-0499

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 IDNCT05742919

Org study IDNN9500-4796

Secondary IDU1111-1267-4230World Health Organization (WHO)

Timeline

Milestones

Study start2023-02-16actual

Study first posted2023-02-24actual

Primary completion2023-06-13actual

Study completion2023-06-13actual

Last update posted2024-06-11actual

Assets

Investigational agents

NNC0194-0499

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age20 Years

Maximum age55 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.

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

•Body mass index (BMI) between 23.0 and 34.9 kilograms per meter square (kg/m^2) (both inclusive).

•Body weight greater than or equal to 60 kg.

•Considered eligible 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

•Known or suspected hypersensitivity to study intervention or related products.

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

Endpoints (10)

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.

Coverage by outcome category

Safety / tolerability / PK

Cardiometabolic biomarkers

3 endpoints

Secondary/protocol endpoint

Relative change in triglycerides

Time frame:From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Relative change in high-density lipoprotein (HDL) cholesterol

Time frame:From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

HDL-C, change

percent change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Relative change in low-density lipoprotein (LDL) cholesterol

Time frame:From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

LDL-C, change

percent change from baseline, improvement

LOINC 13457-7

Safety / tolerability / PK

7 endpoints

Primary/protocol endpoint

AUC0-∞, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single dose

Time frame:From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

AUC0-168h, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single dose

Time frame:From Day 1 (pre-dose) until Day 7 (168 hours)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax, NNC0194-0499: The maximum concentration of NNC0194- 0499 in serum

Time frame:From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax, NNC0194-0499: The time from dose administration to maximum serum concentration of NNC0194-0499

Time frame:From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

Tmax

descriptive

Secondary/protocol endpoint

t1/2, NNC0194-0499: The terminal half-life of NNC0194-0499

Time frame:From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

Half-life

descriptive

Secondary/protocol endpoint

CL/FNNC0194-0499: The apparent total serum clearance of NNC0194-0499

Time frame:From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

descriptive

Secondary/protocol endpoint

Vz/FNNC0194-0499: The apparent volume of distribution of NNC0194-0499 in the terminal phase

Time frame:From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

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.