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NCT04992065 · ClinicalTrials.gov registry record · Phase 2
A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Disease
A Phase 2 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 2
- Development phase
- 267
- Enrollment target
NCT04992065 is a Phase 2 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 267 participants.
The verdict
NCT04992065, a Phase 2 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 267 participants
- Enrollment target
Study Summary
This study looks at how well a new medicine, NNC0385-0434, works to lower blood cholesterol levels. Participants will either get NNC0385-0434 as a tablet (a potential new medicine), or placebo as a tablet (a dummy medicine that looks like NNC0385-0434 but has no effect on the body), or evolocumab as an injection (a medicine that doctors can already prescribe). Which treatment participants get is decided by chance. If participants get NNC0385-0434 or placebo participants will need to take 1 tablet every morning. If participants get evolocumab participants will need to take 1 injection every 2 weeks. The study will last for about 22 weeks. About 255 people will participate in the study. Participants will have 9 visits to the clinic and 2 phone calls with the study doctor. Some people will be invited to participate in a sub-study and will have 4 extra visits (13 visits in total). Participants will have blood samples taken at all visits to the clinic (except visit 0). At 4 clinic visits, participants will have an electrocardiogram (ECG). This is a test to check your heart. Women can only take part in the study if they are not able to become pregnant.
Interventions
- DRUG NNC0385-0434 A 15 mg
- DRUG NNC0385-0434 A 40 mg
- OTHER Placebo I A (for NNC0385-0434 A 15 mg)
- DRUG NNC0385-0434 A 100 mg
- OTHER Placebo I A (for NNC0385-0434 A 40 mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 267 participants |
| Start Date | 2021-08-03 |
| Est. Completion | 2022-06-20 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04992065
The ClinicalTrials.gov registry entry for NCT04992065 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 267 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which NNC0385-0434 A 15 mg is the first listed.
NCT04992065 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04992065 about?
NCT04992065 is a clinical study titled "A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Disease". This study looks at how well a new medicine, NNC0385-0434, works to lower blood cholesterol levels. Participants will either get NNC0385-0434 as a tablet (a potential new medicine), or placebo as a tablet (a dummy medicine that looks like NNC0385-0434 but has no effect on the body), or evolocumab as...
What is the current status of trial NCT04992065?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 267 participants. The study started on 2021-08-03. Estimated completion is 2022-06-20.
What interventions are being tested in trial NCT04992065?
The interventions under investigation include: NNC0385-0434 A 15 mg (DRUG), NNC0385-0434 A 40 mg (DRUG), Placebo I A (for NNC0385-0434 A 15 mg) (OTHER), NNC0385-0434 A 100 mg (DRUG), Placebo I A (for NNC0385-0434 A 40 mg) (OTHER).
Who is sponsoring clinical trial NCT04992065?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
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