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

NCT06559527 | Completed Phase 1

• 3 other identifiers: NN9490-7611U1111-1298-68862023-509961-19
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Cmax,0111,SD: Maximum observed plasma NNC0487-0111concentration after a single dose

  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

  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

  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

  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

  From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)

Study Arms (5)

Mild Renal Impairment

EXPERIMENTAL

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

Moderate Renal Impairment

EXPERIMENTAL

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

Drug: NNC0487-0111

Severe Renal Impairment

EXPERIMENTAL

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

End-Stage Renal Disease (ESRD)

EXPERIMENTAL

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

Drug: NNC0487-0111

Normal Renal Function

EXPERIMENTAL

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

Interventions

NNC0487-0111 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); Mild Renal Impairment; Moderate Renal Impairment; Normal Renal Function; Severe Renal Impairment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

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; Obesity; Overweight

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: August 20, 2024
• Primary Completion: February 24, 2025
• Study Completion: March 5, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)