Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 6:04 PM
Study NCT ID:
NCT04058834
Status:
COMPLETED
Last Update Posted:
2021-12-30
First Post:
2019-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Research Study Investigating How NNC0385-0434 is Tolerated in People With or Without High Cholesterol Levels
Sponsor:
Novo Nordisk A/S
Organization:
Study Overview
Official Title:
A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of Single Doses of NNC0385-0434 in Healthy Subjects and Patients With Hypercholesterolaemia
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study, there are two study medicines: NNC0385-0434 (the new medicine being tested) and placebo (a 'dummy' medicine). Participants will only get one of these medicines - which one is decided by chance. The study medicine for each person is chosen by a computer. A dummy medicine (placebo) looks like the study medicine but has no effect on the body. The dummy medicine needs to be used in the study to find out if the study medicine works as expected. The dose of the study medicines that participants receive will depend on which group they get into. The study has 4 groups of 8-15 participants in each. Each group will get a different dose of NNC0385-0434 or placebo. Participants and the study doctor will not know which of the study medicine/dose participants will get. However, if a participant's safety is at risk, the study doctor will be told in order to decide the future treatment. NNC0385-0434 may help to clear cholesterol from the blood. When there is less cholesterol circulating in the blood over a long period of time, then there is less risk of arteries (blood vessels) being clogged or developing diseases of the heart and blood vessels. Each participant will get one injection under the skin and will be in the study for about 4 months.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: