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NCT Number: NCT06370819

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

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charité - Campus Charité Mitte - Charité Research Organisation GmbH

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

NNC0519-0130

Drug

NNC0519-0130 will be administered subcutaneously.

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

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

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

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

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

    Measured in nanomoles per litre (nmol/L).

  2. 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)

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

  3. 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)

    Measured in nanomoles per litre (nmol/L).

  4. Number of adverse events

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

    Number of events.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 17, 2024
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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