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

NCT06370819 | Completed Phase 1

• 3 other identifiers: NN9541-4923U1111-1292-34412023-506381-32
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (4)

• 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)

• 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)

• 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)

• Number of adverse events

  From time of dosing (visit 2, day 1) until end of study (visit 9, day 22)

Study Arms (1)

NNC0519-0130

EXPERIMENTAL

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

Drug: NNC0519-0130

Interventions

NNC0519-0130 DRUG

NNC0519-0130 will be administered subcutaneously.

NNC0519-0130

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Charité Research Organisation GmbH

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 17, 2024
• Study Start: April 15, 2024
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)