Status:
COMPLETED
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
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 2
Obesity
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2025
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06559527
Start Date
August 20 2024
End Date
March 5 2025
Last Update
March 30 2025
Active Locations (1)
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1
Charité Research Organisation GmbH
Berlin, Germany, 10117