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Completed

NCT Number: NCT06559527

A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function

Novo Nordisk is developing the study medicine NNC0487-0111 to treat people living with type 2 diabetes and/or people living with overweight or obesity. The aim of this study is to see if blood levels of NNC0487-0111 are the same in people living with various degrees of reduced kidney function as for people with normal kidney function. Participants will be given one single injection by the study staff in a skinfold in their stomach using a pen device (NovoPen®4).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charité Research Organisation GmbH

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female, aged 18-80 years (both inclusive) at the time of signing the informed consent
  • Body mass index (BMI) between 20.0 and 39.9 kilogram per square meter (kg/m^2) (both inclusive) at screening.
  • Meeting the pre-defined eGFR values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (2021) adjusted for the estimated individual body surface area (BSA);
  • Normal renal function - greater than or equal to 90 mL/min
  • Mild renal impairment - 60 - 89 (mL/min)
  • Moderate renal impairment - 30 - 59 (mL/min)
  • Severe renal impairment - less than 30 (mL/min) not requiring dialysis
  • End-stage renal disease (ESRD) - Requiring dialysis treatment
  • For ESRD: Participants requiring dialysis treatment should be on current treatment with haemodialysis.

Exclusion criteria

  • Any disorder, unwillingness, or inability which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
  • 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 dosing the investigational medicinal product (IMP).
  • Presence or history of any clinically relevant respiratory, metabolic, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions(except conditions associated with renal impairment or ESRD).

Treatment and study plan

NNC0487-0111

Drug

Participants will administer a single dose of NNC0487-0111 subcutaneously using NovoPen®4 by injection into a skinfold on the abdomen.

Primary outcomes

  1. AUC0111,0-∞,SD: Area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose

    Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)

    Measured as hours*nanomole per liter (h*nmol/L).

Secondary outcomes

  1. Cmax,0111,SD: Maximum observed plasma NNC0487-0111concentration after a single dose

    Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)

    Measured as nanomole per liter (nmol/L).

  2. tmax,0111,SD: Time to maximum observed plasma NNC0487-0111 concentration after a single dose

    Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)

    Measured as hours.

  3. t½,0111,SD: Terminal half-life of NNC0487-0111 after a single dose

    Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)

    Measured as hours.

  4. Vz/F0111,SD: Apparent volume of distribution of NNC0487-0111 after a single dose

    Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)

    Measured as liter (L)

  5. CL/F0111,SD: Apparent clearance of NNC0487-0111 after a single dose

    Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)

    Measured as liter per hour (L/h).

  6. 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 study visit (Visit 9, Day 28)

    Measured as number of events.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Investigation of Pharmacokinetics, Safety and Tolerability of a Single Subcutaneous Dose of NNC0487-0111 in Participants With Various Degrees of Renal Impairment and Normal Renal Function

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2024
Registry last updated
Mar 30, 2025

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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