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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: Completed Phase 2 study, sponsored by Novo Nordisk A/S.
NCT04992065 is a Phase 2 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 267 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (101% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentage change in LDL-cholesterol (LDL-C) (measured in milligrams per deciliter \[mg/dL\]) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in
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 |
What the finished NCT04992065 record still lists
NCT04992065 is an interventional study that assigns participants to a tested intervention. The registered 267 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (101% higher).
The record links to 0 conditions, and to 5 interventions - of which NNC0385-0434 A 15 mg is the first listed.
NCT04992065 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04992065's enrollment target sits among peer trials
267 209th of 2000 higher than 1,792 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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