GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Research Study Looking Into Blood Levels of the Medicine NNC0519-0130 in the Body in Participants With Normal or Reduced Kidney Function

Investigation of the Effect of Impaired Renal Function on the Pharmacokinetics of Subcutaneously Administered NNC0519-0130 in Participants With Various Degrees of Renal Function

Lead sponsor

Novo Nordisk A/S

Asset

NNC0519-0130

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Renal impairment

Key I/E criterion

•BMI 20-39.9

Primary endpoint

•Area under the curve (AUC)0-∞,NNC0519-0130,SD

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 IDNCT06370819

Org study IDNN9541-4923

Secondary ID2023-506381-32EU CT Number

Secondary IDU1111-1292-3441Universal Trial Number

Timeline

Milestones

Study start2024-04-15actual

Study first posted2024-04-17actual

Primary completion2024-11-27actual

Study completion2024-11-27actual

Last update posted2026-04-07actual

Assets

Investigational agents

NNC0519-0130

Study populations

Who this study enrolls

Healthy volunteersRenal impairment

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Male or female of non-childbearing potential, aged 18-75 years (both inclusive) at the time of signing the informed consent.

•Body mass index (BMI) between 20.0 and 39.9 kilogram per square metre (kg/m^2) (both inclusive) at screening.

•Meeting the pre-defined glomerular filtration rate (GFR) criteria using estimated GFR (eGFR) based on the chronic kidney disease epidemiology collaboration (CKD-EPI) Creatinine Equation (2021) adjusted for estimated individual body surface area (BSA) for any of the renal function groups:

•For participants with normal renal function: eGFR of greater than or equal to 90 millilitres per minute (mL/min)

•Stage 2: For participants with mild renal impairment: eGFR of 60-89 mL/min

•Stage 3: For participants with moderate renal impairment: eGFR of 30-59 mL/min

•Stage 4: For participants with severe renal impairment: eGFR of 15-29 mL/min not requiring dialysis

•Stage 5: For participants with kidney failure: eGFR of less than 15 mL/min and requiring dialysis treatment

Exclusion criteria

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

•Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with renal impairment or kidney failure) as judged by the investigator.

•Use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside, antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim, cibenzoline and nitrofurantoin within 14 days or 5 half-lives, whichever is greater, before planned dosing of the investigational medicinal product (IMP).

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

Area under the curve (AUC)0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with normal function, and mild, moderate and severe impairment

Time frame:From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum concentration (Cmax),NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with normal function, and mild, moderate and severe impairment

Time frame:From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)

Cmax

concentration, descriptive

Secondary/protocol endpoint

AUC0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with kidney failure

Time frame:From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with kidney failure

Time frame:From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Number of adverse events

Time frame:From time of dosing (visit 2, day 1) until end of study (visit 9, day 22)

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.