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

Last updated: March 28, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

1

Condition

Obesity

Diabetes Mellitus, Type 2

Diabetes Prevention

Treatment

NNC0487-0111

Clinical Study ID

NCT06559527
NN9490-7611
2023-509961-19
U1111-1298-6886
  • Ages 18-80
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female, aged 18-80 years (both inclusive) at the time of signing theinformed consent

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

  • Meeting the pre-defined eGFR values based on the Chronic Kidney Disease EpidemiologyCollaboration (CKD-EPI) creatinine equation (2021) adjusted for the estimatedindividual 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 treatmentwith haemodialysis.

Exclusion

Exclusion Criteria:

  • Any disorder, unwillingness, or inability which in the investigator's opinion mightjeopardize participant's safety or compliance with the protocol.

  • 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 isgreater, before dosing the investigational medicinal product (IMP).

  • Presence or history of any clinically relevant respiratory, metabolic, hepatic,cardiovascular, gastrointestinal, or endocrinological conditions(except conditionsassociated with renal impairment or ESRD).

Study Design

Total Participants: 42
Treatment Group(s): 1
Primary Treatment: NNC0487-0111
Phase: 1
Study Start date:
August 20, 2024
Estimated Completion Date:
March 05, 2025

Connect with a study center

  • Charité Research Organisation GmbH

    Berlin, 10117
    Germany

    Site Not Available

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