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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: NNC0519-0130

Study type

Interventional

Funder types

Industry

Identifiers

NCT06370819

NN9541-4923

U1111-1292-3441 (Other Identifier)

2023-506381-32 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female of non-childbearing potential, aged 18-75 years (both inclusive) at the time of signing the informed consent.
Body mass index (BMI) between 20.0 and 39.9 kilogram per square metre (kg/m^2) (both inclusive) at screening.
Meeting the pre-defined glomerular filtration rate (GFR) criteria using estimated GFR (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 90 millilitres 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 not requiring dialysis
Stage 5: For participants with kidney failure: eGFR of less than 15 mL/min and requiring dialysis treatment

Exclusion criteria

Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with renal impairment or kidney failure) as judged by the investigator.
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 planned dosing of the investigational medicinal product (IMP).