Diabetes Mellitus, Type 2, Obesity, Overweight
Conditions
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 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).
Interventions
DRUGNNC0487-0111
Participants will administer a single dose of NNC0487-0111 subcutaneously using NovoPen®4 by injection into a skinfold on the abdomen.
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0111,0-∞,SD: Area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose | 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
| Measure | Time frame | Description |
|---|---|---|
| tmax,0111,SD: Time to maximum observed plasma NNC0487-0111 concentration after a single dose | From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28) | Measured as hours. |
| t½,0111,SD: Terminal half-life of NNC0487-0111 after a single dose | From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28) | Measured as hours. |
| Cmax,0111,SD: Maximum observed plasma NNC0487-0111concentration after a single dose | 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). |
| CL/F0111,SD: Apparent clearance of NNC0487-0111 after a single dose | 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). |
| Number of treatment emergent adverse events (TEAEs) | 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. |
| Vz/F0111,SD: Apparent volume of distribution of NNC0487-0111 after a single dose | From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28) | Measured as liter (L) |
Countries
Germany
Outcome results
None listed