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

Investigation of Pharmacokinetics, Safety and Tolerability of a Single Subcutaneous Dose of NNC0487-0111 in Participants With Various Degrees of Renal Impairment and Normal Renal Function

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).

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes Mellitus, Type 2; Overweight
• Intervention / Treatment: Drug: NNC0487-0111

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité Research Organisation GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: NNC0487-0111; Participants will administer a single dose of NNC0487-0111 subcutaneously using NovoPen®4 by injection into a skinfold on the abdomen.
Experimental: Moderate Renal Impairment; Participants with moderate renal impairment (eGFR - 30 - 59 mL/min) will administer a single dose of NNC0487-0111 on Day 1.	Drug: NNC0487-0111; Participants will administer a single dose of NNC0487-0111 subcutaneously using NovoPen®4 by injection into a skinfold on the abdomen.
Experimental: 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.	Drug: NNC0487-0111; Participants will administer a single dose of NNC0487-0111 subcutaneously using NovoPen®4 by injection into a skinfold on the abdomen.
Experimental: End-Stage Renal Disease (ESRD); Participants with ESRD (requiring dialysis treatment) will administer a single dose of NNC0487-0111 on Day 1.	Drug: NNC0487-0111; Participants will administer a single dose of NNC0487-0111 subcutaneously using NovoPen®4 by injection into a skinfold on the abdomen.
Experimental: 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.	Drug: NNC0487-0111; Participants will administer a single dose of NNC0487-0111 subcutaneously using NovoPen®4 by injection into a skinfold on the abdomen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0111,0-∞,SD: Area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose	Measured as hours*nanomole per liter (h*nmol/L).	From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax,0111,SD: Maximum observed plasma NNC0487-0111concentration after a single dose	Measured as nanomole per liter (nmol/L).	From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
tmax,0111,SD: Time to maximum observed plasma NNC0487-0111 concentration after a single dose	Measured as hours.	From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
t½,0111,SD: Terminal half-life of NNC0487-0111 after a single dose	Measured as hours.	From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
Vz/F0111,SD: Apparent volume of distribution of NNC0487-0111 after a single dose	Measured as liter (L)	From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
CL/F0111,SD: Apparent clearance of NNC0487-0111 after a single dose	Measured as liter per hour (L/h).	From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
Number of treatment emergent adverse events (TEAEs)	Measured as number of events.	From time of trial product administration (Visit 2, Day 1) until completion of the end of study visit (Visit 9, Day 28)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2024
• Primary Completion (Actual): February 24, 2025
• Study Completion (Actual): March 5, 2025

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Overweight; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NN9490-7611; U1111-1298-6886 (Other Identifier: World Health Organization (WHO)); 2023-509961-19 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No