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CompletedNCT06370819Updated Apr 7, 2026

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

A Phase 1 interventional study of NNC0519-0130 in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-07.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

NNC0519-0130 is a new medicine to improve the treatment options for people living with type 2 diabetes and people with overweight. In this study one dose of NNC0519-0130 will be given and blood levels of NNC0519-0130 will be compared between people with reduced kidney function and people with normal kidney function. The study will last up to 52 days including a screening phase of up to 28 days prior to dosing.

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Conditions studied

  • Diabetes Mellitus, Type 2
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In context

Diabetes Mellitus, Type 2

9,362 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,317 are open to participants now.

This study's enrollment of 36 is below the median of 80 across 7,528 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 101 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    NNC0519-0130

    Participants will receive single subcutaneous (s.c.) dose of NNC0519-0130.

    Drug: NNC0519-0130

Interventions

  • DrugNNC0519-0130

    NNC0519-0130 will be administered subcutaneously.

06

What researchers measure

Primary outcomes

  1. 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

    Measured in hours\* nanomoles per litre (h\*nmol/L).

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

Secondary outcomes

  1. 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

    Measured in nanomoles per litre (nmol/L).

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

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

    Measured in hours\* nanomoles per litre (h\*nmol/L).

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

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

    Measured in nanomoles per litre (nmol/L).

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

  4. Number of adverse events

    Number of events.

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

07

Study locations

1 site
  • Charité - Campus Charité Mitte - Charité Research Organisation GmbH
    Berlin, 10117, Germany
08

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06370819
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Apr 17, 2024
Start date
Apr 15, 2024
Primary completion
Nov 27, 2024
Completion
Nov 27, 2024
Last update
Apr 7, 2026

Study contacts

Clinical Transparency (dept. 2834)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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