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

Sponsor
Novo Nordisk A/S
Study ID
NCT06559527
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.

Study Details

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).

Key Dates

Start date
Aug 20, 2024
Status verified
Mar 2025
Primary completion
Feb 24, 2025
Completion
Mar 5, 2025

Study Design

Enrollment
42 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.
  • Experimental: End-Stage Renal Disease (ESRD)
    Participants with ESRD (requiring dialysis treatment) will administer a single dose of NNC0487-0111 on Day 1.
  • 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.

Primary Outcome Measure

AUC0111,0-∞,SD: Area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose [ Time Frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28) ]

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