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

NCT ID: NCT06370819

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2024-11-27

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NNC0519-0130

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

Group Type: EXPERIMENTAL

NNC0519-0130

Intervention Type: DRUG

NNC0519-0130 will be administered subcutaneously.

Interventions

NNC0519-0130

NNC0519-0130 will be administered subcutaneously.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Charité Research Organisation GmbH

Berlin, , Germany

Countries

Germany

Other Identifiers

U1111-1292-3441

Identifier Type: OTHER

Identifier Source: secondary_id

2023-506381-32

Identifier Type: OTHER

Identifier Source: secondary_id

NN9541-4923

Identifier Type: -

Identifier Source: org_study_id