GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Research Study Looking at How the Medicine NNC0194-0499 Behaves in Japanese and Non-Asian Men

Investigation of Safety, Tolerability and Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0194-0499 in Japanese and Non-Asian Male Subjects

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

•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 IDNCT04722653

Org study IDNN9500-4663

Secondary IDU1111-1255-1392World Health Organization (WHO)

Timeline

Milestones

Study first posted2021-01-25actual

Study start2021-02-02actual

Primary completion2021-04-27actual

Study completion2021-04-27actual

Last update posted2022-04-05actual

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

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

•For Japanese subjects only, both parents of Japanese descent. For non-Asian subjects only, both parents of non-Asian descent

•Body mass index (BMI) between 23.0 and 34.9 kg/m^2 (both inclusive)

•Body weight greater than or equal to 60 kg

Exclusion criteria

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

•Subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic cardiovascular disease risk (as described in the American College of Cardiology and the American Heart Association Prevention Guideline) greater than or equal to 5 percentage

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.

Safety / tolerability / PK

10 endpoints

Primary/protocol endpoint

Number of treatment emergent adverse events (TEAEs)

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

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

AUC0-∞, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single s.c.(subcutaneous) administration