GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Research Study Looking at How a Single Dose of the Study Medicine NNC0194-0499 Behaves in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function

Investigation of Pharmacokinetics, Safety and Tolerability of a Single Subcutaneous Dose of NNC0194-0499 in Participants With Various Degrees of Hepatic Impairment and Normal Hepatic Function

Lead sponsor

Novo Nordisk A/S

Asset

NNC0194-0499

Subcutaneous · FGF21 analog

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Hepatic impairment

Key I/E criterion

•BMI 18.5-39.9

Primary endpoint

•AUC0-∞, Single Dose, 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 IDNCT05917938

Org study IDNN9500-4621

Secondary ID2022-001835-10

Secondary IDU1111-1278-1745World Health Organization (WHO)

Timeline

Milestones

Study first posted2023-06-26actual

Study start2023-07-04actual

Primary completion2024-12-16actual

Study completion2024-12-16actual

Last update posted2026-02-11actual

Assets

Investigational agents

NNC0194-0499

Study populations

Who this study enrolls

Healthy volunteersHepatic impairment

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Male or female.

•Aged 18-80 years (both inclusive) at the time of signing informed consent.

•Body mass index (BMI) between 18.5-39.9 kilogram per square meter (kg/m^2) (both inclusive). Specific inclusion criterion only for participants with hepatic impairment:

•Participants with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by the investigator. Stable hepatic impairment is defined as no clinically significant change in disease status, as judged by the investigator.

Exclusion criteria

•Known or suspected hypersensitivity to study intervention(s) or related products.

•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.

Endpoints (7)

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

7 endpoints

Primary/protocol endpoint

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

Time frame:From 0 hours (Day 1) until end of study visit (Day 36)

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

concentration, descriptive

Secondary/protocol endpoint

t1/2, NNC0194-0499: the terminal half-life of NNC0194-0499 in serum

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/F, NNC0194-0499: 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/F, NNC0194-0499: apparent volume of distribution of NNC0194-0499 after a single dose

Time frame:From Day 1 (pre-dose) until completion of the end of trial visit (Day 36)

descriptive

Secondary/protocol endpoint

Number of treatment emergent adverse events (TEAEs)

Time frame:From time of trial product administration (Visit 2, Day 1) until completion of the end of trial visit (Visit 8, Day 36)

Treatment-emergent AEs (any)

event count, event

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.