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

Last updated: April 8, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

1

Condition

Diabetes Mellitus, Type 2

Treatment

NNC0519-0130

Clinical Study ID

NCT06370819
NN9541-4923
U1111-1292-3441
2023-506381-32
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

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

  • Meeting the pre-defined glomerular filtration rate (GFR) criteria using estimatedGFR (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 90millilitres 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 notrequiring dialysis

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

Exclusion

Exclusion Criteria:

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

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

  • Use of drugs known to affect creatinine clearance including cephalosporin andaminoglycoside, 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).

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: NNC0519-0130
Phase: 1
Study Start date:
April 15, 2024
Estimated Completion Date:
November 27, 2024

Connect with a study center

  • Charité Research Organisation GmbH

    Berlin, 10117
    Germany

    Site Not Available

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