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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Overweight; Obesity; Diabetes Mellitus, Type 2

Treatments: Drug: NNC0487-0111

Study type: Interventional

Funder types: Industry

Identifiers

NCT06559527

U1111-1298-6886 (Other Identifier)

2023-509961-19 (Other Identifier)

NN9490-7611

Details and patient eligibility

About

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).

Enrollment: 42 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 5 patient groups

Mild Renal Impairment

Experimental group

Description:

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.

Treatment:

Drug: NNC0487-0111

Moderate Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: NNC0487-0111

Severe Renal Impairment

Experimental group

Description:

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.

Treatment:

Drug: NNC0487-0111

End-Stage Renal Disease (ESRD)

Experimental group

Description:

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

Treatment:

Drug: NNC0487-0111

Normal Renal Function

Experimental group

Description:

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

Treatment:

Drug: NNC0487-0111