CompletedPhase 1

A Research Study Looking Into Blood Levels of the Medicine NNC0480-0389 in Participants With Reduced Kidney Function Compared to Participants With Normal Kidney Function

Investigation of the Pharmacokinetics of Subcutaneously Administered NNC0480-0389 in Participants With Various Degrees of Impaired Renal Function Compared to Participants With Normal Renal Function

Lead sponsor

Novo Nordisk A/S

Asset

NNC0480-0389

Subcutaneous · GIP agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers, Renal impairment

Eligibility highlights

•BMI 20-39.9

Primary endpoint

•AUC0-∞,NNC0480-0389,SD, AUC of NNC0480-0389 after a single dose

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 IDNCT05015894

Org study IDNN9389-4682

Secondary ID2021-001450-57

Secondary IDU1111-1266-0594World Health Organization (WHO)

Timeline

Milestones

Study first posted2021-08-23actual

Study start2021-08-30actual

Primary completion2022-08-02actual

Study completion2022-08-02actual

Last update posted2023-11-13actual

Assets

Investigational agents

NNC0480-0389

Who this study enrolls

Healthy volunteersRenal impairment

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 informed consent.

•Body mass index (BMI) between 20.0 and 39.9 kg/m^2 (both inclusive)

•Meeting the pre-defined GFR criteria using estimated GFR (eGFR) based on serum creatinine for any of the renal function groups:

-For participants with normal renal function: eGFR of equal to or greater than 90 mL/min

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

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

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

-For participants with kidney failure: eGFR of less than 15 mL/min or requiring dialysis treatment

Specific inclusion criteria for participants with kidney failure requiring dialysis treatment:

* Current treatment with haemodialysis

Exclusion criteria

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

•Use of prescription medicinal products or non-prescription drugs, or non-routine vitamins, which at the investigators judgement may affect participant safety or the results of the study within 14 days before screening.

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

•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).

Endpoints (2)

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

2 endpoints

Primary/protocol endpoint

AUC0-∞,NNC0480-0389,SD, area under the NNC0480-0389 plasma concentration time curve after a single dose

Time frame:From baseline (visit 2, day 1, pre-dose) until completion of the end-of-study visit (visit 11, day 36)

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,NNC0480-0389,SD, Maximum observed NNC0480-0389 plasma concentration after a single dose

Time frame:From baseline (visit 2, day 1, pre-dose) until completion of the end-of-study visit (visit 11, day 36)

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.