NCT05015894

A Research Study Looking Into Blood Levels of the Medicine NNC0480-0389 in Participants With Reduced Kidney Function Compared to Participants With Normal Kidney Function

Investigation of the Pharmacokinetics of Subcutaneously Administered NNC0480-0389 in Participants With Various Degrees of Impaired Renal Function Compared to Participants With Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Novo Nordisk is developing a combination therapy with the study medicine NNC0480-0389 and an already approved medicine called "semaglutide" for the treatment of type-2 diabetes (T2D). It is expected that the combination will further improve the blood sugar control compared to semaglutide therapy alone.In this study the blood levels of NNC0480-0389 will be compared in people with various degrees of reduced kidney function to the blood levels in people with normal kidney function, after administration of one dose of 18 mg NNC0480-0389. Participants will only get the study medicine as two injections into a skinfold of participants belly (subcutaneous). The study will last for about 65 days including a screening phase of up to 28 days prior to dosing. If participants are eligible for the study, participants will have 11 visits to the study centre including one in-house stay of 5 days and 4 nights (Visit 2) and nine ambulatory visits (Visit 3 to Visit 11). Participants' vital signs (heart rate, blood pressure, body temperature) will be measured, participants will have blood drawn, urine will be collected and electrocardiograms (ECGs) will be recorded.If participants are women and can get pregnant they cannot take part in the study. A hormone test will be done to check if participants may be post-menopausal.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	NNC0480-0389	A single dose of 18 mg NNC0480 0389 administered subcutaneously (under the skin). Total duration of study participation for each participant is 38 to 66 days

Timeline

• Start date: 2021-08-30
• Primary completion: 2022-08-02
• Completion: 2022-08-02
• First posted: 2021-08-23
• Last updated: 2023-11-13

Locations

1 site across 1 country: Germany