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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Investigation of the Effect of Impaired Renal Function on the Pharmacokinetics of Subcutaneously Administered NNC0519-0130 in Participants With Various Degrees of Renal Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06370819
• Other study ID #: NN9541-4923
• Secondary ID: U1111-1292-34412
• Status: Recruiting
• Phase: Phase 1
• Start date: April 15, 2024
• Est. completion date: April 19, 2025

Study information

• Verified date: April 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: April 19, 2025
• Est. primary completion date: April 19, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• NNC0519-0130
NNC0519-0130 will be administered subcutaneously.

Locations

Country	Name	City	State
Germany	Charité Research Organisation GmbH	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC)0-8,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with normal function, and mild, moderate and severe impairment	Measured in hours* nanomoles per litre (h*nmol/L).	From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)
Secondary	Maximum concentration (Cmax),NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with normal function, and mild, moderate and severe impairment	Measured in nanomoles per litre (nmol/L).	From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)
Secondary	AUC0-8,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with kidney failure	Measured in hours* nanomoles per litre (h*nmol/L).	From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)
Secondary	Cmax,NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with kidney failure	Measured in nanomoles per litre (nmol/L).	From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)
Secondary	Number of adverse events	Number of events.	From time of dosing (visit 2, day 1) until end of study (visit 9, day 22)