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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: NNC0519-0130

• Registration Number: NCT06370819
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-12
• Study First Submitted QC: 2024-04-12
• Study Start: 2024-04-15
• Study First Posted: 2024-04-17
• Primary Completion: 2024-11-27
• Study Completion: 2024-11-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NNC0519-0130	NNC0519-0130	Participants will receive single subcutaneous (s.c.) dose of NNC0519-0130.

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC)0-∞,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	From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)	Measured in hours\* nanomoles per litre (h\*nmol/L).

Secondary Outcome Measures

Name	Time	Method
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	From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)	Measured in nanomoles per litre (nmol/L).
AUC0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with kidney failure	From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)	Measured in hours\* nanomoles per litre (h\*nmol/L).
Cmax,NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with kidney failure	From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)	Measured in nanomoles per litre (nmol/L).
Number of adverse events	From time of dosing (visit 2, day 1) until end of study (visit 9, day 22)	Number of events.

Trial Locations

Locations (1)

Charité Research Organisation GmbH; 🇩🇪 Berlin, Germany