A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function

NCT ID: NCT06559527

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-20
• Study Completion Date: 2025-03-05

Brief Summary

Novo Nordisk is developing the study medicine NNC0487-0111 to treat people living with type 2 diabetes and/or people living with overweight or obesity. The aim of this study is to see if blood levels of NNC0487-0111 are the same in people living with various degrees of reduced kidney function as for people with normal kidney function. Participants will be given one single injection by the study staff in a skinfold in their stomach using a pen device (NovoPen®4).

Conditions

Diabetes Mellitus, Type 2; Obesity; Overweight

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mild Renal Impairment

Participants with mild renal impairment (estimated glomerular filtration rate \[eGFR\] - 60 - 89 milliliter per min \[mL/min\]) will administer a single dose of NNC0487-0111 on Day 1.

Group Type: EXPERIMENTAL

NNC0487-0111

Intervention Type: DRUG

Participants will administer a single dose of NNC0487-0111 subcutaneously using NovoPen®4 by injection into a skinfold on the abdomen.

Moderate Renal Impairment

Participants with moderate renal impairment (eGFR - 30 - 59 mL/min) will administer a single dose of NNC0487-0111 on Day 1.

Group Type: EXPERIMENTAL

NNC0487-0111

Intervention Type: DRUG

Participants will administer a single dose of NNC0487-0111 subcutaneously using NovoPen®4 by injection into a skinfold on the abdomen.

Severe Renal Impairment

Participants with severe renal impairment (eGFR - less than 30 mL/min not requiring dialysis) will administer a single dose of NNC0487-0111 on Day 1.

Group Type: EXPERIMENTAL

NNC0487-0111

Intervention Type: DRUG

Participants will administer a single dose of NNC0487-0111 subcutaneously using NovoPen®4 by injection into a skinfold on the abdomen.

End-Stage Renal Disease (ESRD)

Participants with ESRD (requiring dialysis treatment) will administer a single dose of NNC0487-0111 on Day 1.

Group Type: EXPERIMENTAL

NNC0487-0111

Intervention Type: DRUG

Participants will administer a single dose of NNC0487-0111 subcutaneously using NovoPen®4 by injection into a skinfold on the abdomen.

Normal Renal Function

Participants with normal renal function (eGFR - greater than or equals 90) will administer a single dose of NNC0487-0111 on Day 1.

Group Type: EXPERIMENTAL

NNC0487-0111

Intervention Type: DRUG

Participants will administer a single dose of NNC0487-0111 subcutaneously using NovoPen®4 by injection into a skinfold on the abdomen.

Interventions

NNC0487-0111

Participants will administer a single dose of NNC0487-0111 subcutaneously using NovoPen®4 by injection into a skinfold on the abdomen.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female, aged 18-80 years (both inclusive) at the time of signing the informed consent
• Body mass index (BMI) between 20.0 and 39.9 kilogram per square meter (kg/m^2) (both inclusive) at screening.
• Meeting the pre-defined eGFR values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (2021) adjusted for the estimated individual body surface area (BSA);

• Normal renal function - greater than or equal to 90 mL/min
• Mild renal impairment - 60 - 89 (mL/min)
• Moderate renal impairment - 30 - 59 (mL/min)
• Severe renal impairment - less than 30 (mL/min) not requiring dialysis
• End-stage renal disease (ESRD) - Requiring dialysis treatment
• For ESRD: Participants requiring dialysis treatment should be on current treatment with haemodialysis.

Exclusion Criteria

• Any disorder, unwillingness, or inability which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
• 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 dosing the investigational medicinal product (IMP).
• Presence or history of any clinically relevant respiratory, metabolic, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions(except conditions associated with renal impairment or ESRD).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

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

U1111-1298-6886

Identifier Type: OTHER

Identifier Source: secondary_id

2023-509961-19

Identifier Type: OTHER

Identifier Source: secondary_id

NN9490-7611

Identifier Type: -

Identifier Source: org_study_id