MedTrace Logo

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

NCT05015894 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-11-13

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency (Dept. 1452) · Novo Nordisk A/S

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-30
Primary Completion
2022-08-02
Completion
2022-08-02

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05015894 on ClinicalTrials.gov