Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT05094934
Brief Summary:
Novo Nordisk is developing a new medicine, NNC0385-0434, to help people lower their cholesterol level.
The aim of this study is to look at how NNC0385-0434 works in the body and how it is removed from the body in people with impaired kidney function.
All participants will receive the same dose (100 mg) of the study medicine NNC0385-0434, which will be given for 10 days in a row. Participants will get the study medicine in a tablet taken orally once-daily. The study medicine needs to be taken in the morning after overnight fasting and 30 minutes before the first meal of the day.
The study will last for about 9-14 weeks.
Participants will have 15 visits to the study centre, including 2 in-house stays of 3 days and 2 nights and 13 ambulatory visits.
Participants' vital signs (heart rate, blood pressure, body temperature) will be measured, participants will have blood draws, urine will be collected and electrocardiograms (ECGs) will be recorded.
Participants cannot take part in the study if they have gastrointestinal disorders or unusual meal habits and special dietary requirements.
Women can only take part in the study if they cannot get pregnant.
Study:
NCT05094934
Study Brief:
Protocol Section:
NCT05094934