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
Public ClinicalTrials.gov record NCT04992065. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Dose Response and Safety of an Oral PCSK9i, NNC0385-0434, in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD Risk on Maximally Tolerated Statin Dose and Other Lipid-lowering Therapy Requiring Further LDL-C Reduction
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04992065
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 267 participants
Conditions and interventions
Conditions
Interventions
- 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
- Placebo II A (for NNC0385-0434 A 100 mg) Other
- Evolocumab 140 mg/mL, Repatha® Drug
Drug · Other
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 3, 2021 (Actual)
- Primary completion
- Apr 26, 2022 (Actual)
- Completion
- Jun 20, 2022 (Actual)
- Last update posted
- Jun 8, 2025
2021 – 2022
United States locations
- U.S. sites
- 13
- U.S. states
- 7
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Desert Oasis Hlthcr Med Group | Palm Springs | California | 92262 | — |
| Excel Med Ctr Clinical Trials | Boca Raton | Florida | 33434 | — |
| Integrative Research Associates, Inc | Fort Lauderdale | Florida | 33312 | — |
| Jacksonville Ctr For Clin Res | Jacksonville | Florida | 32216 | — |
| Northwest Heart Clin. Res. | Arlington Heights | Illinois | 60005 | — |
| Louisiana Heart Center | Covington | Louisiana | 70433 | — |
| Louisiana Heart Center_Slidell | Slidell | Louisiana | 70458 | — |
| VA NEB - Western IA Health Stm | Omaha | Nebraska | 68105 | — |
| Univ of Nebraska Medical CTR | Omaha | Nebraska | 68198 | — |
| Albany Medical College - Endo | Albany | New York | 12203 | — |
| Southgate Medical Group, LLP | West Seneca | New York | 14224 | — |
| Thyroid, Endocrinology, and Diabetes, PA | Dallas | Texas | 75208 | — |
| PlanIt Research, PLLC | Houston | Texas | 77079 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 31 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04992065, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 8, 2025 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04992065 live on ClinicalTrials.gov.