Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04992065 | 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 | PHASE2 | COMPLETED | 267 | — | — | Aug 3, 2021 | Jun 20, 2022 | Jun 8, 2025 | 44 | United States, Belgium +5 |
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-trial' observation period. The in-trial period is defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
| Arm | Type | Description |
|---|---|---|
| Oral NNC0385-0434 15 mg once-daily (OD) | EXPERIMENTAL | 15 mg NNC0385-0434 co-formulated with 500 mg Salcaprozate sodium (SNAC) tablet once daily |
| Oral placebo (NNC0385-0434 15 mg) | PLACEBO_COMPARATOR | 15 MG placebo administered as tablets (without SNAC) once daily |
| Oral NNC0385-0434 40 mg OD | EXPERIMENTAL | 40 mg study drug co-formulated with 500 mg SNAC tablet once daily |
| Oral placebo (NNC0385-0434 40 mg) | PLACEBO_COMPARATOR | placebo administered as tablets (without SNAC) once daily |
| Oral NNC0385-0434 100 mg | EXPERIMENTAL | 100 mg NNC0385-0434 co-formulated with 500 mg SNAC tablet once daily (51 participants) |
| Oral placebo (NNC0385-0434 100 mg) | PLACEBO_COMPARATOR | placebo administered as tablets (without SNAC) once daily |
| Subcutaneous evolocumab 140 mg Q2W | ACTIVE_COMPARATOR | 140 mg evolocumab Subcutaneous (s.c.) injections every 2 weeks (51 participants). The s.c. evolocumab arm is open-label to limit unnecessary injections |
| Name | Type | Description |
|---|---|---|
| NNC0385-0434 A 15 mg | DRUG | 15 mg administered as one oral tablet once daily in the morning in a fasting state. The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day. The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces). |
| NNC0385-0434 A 40 mg | DRUG | 40 mg administered as one oral tablet once daily in the morning in a fasting state. The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day. The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces). |
| Placebo I A (for NNC0385-0434 A 15 mg) | OTHER | Placebo administered as 1 tablet once daily in the morning in a fasting state. The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day. The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces). placebo tablets are sized match to the active arm within dose level |
| NNC0385-0434 A 100 mg | DRUG | 100 mg administered as one oral tablet once daily in the morning in a fasting state. The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day. The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces). |
| Placebo I A (for NNC0385-0434 A 40 mg) | OTHER | Placebo administered as one tablet once daily in the morning in a fasting state. The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day. The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces). placebo tablets are sized match to the active arm within dose level |
| Placebo II A (for NNC0385-0434 A 100 mg) | OTHER | Placebo administered as one tablet once daily in the morning in a fasting state. The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day. The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces). placebo tablets are sized match to the active arm within dose level |
| Evolocumab 140 mg/mL, Repatha® | DRUG | Every 2 weeks subcutaneous (s.c.) injection of 140 mg into areas of the abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated. Administered using a pre-filled SureClick® autoinjector (single-use). Dose volume: 1 mL |
Inclusion Criteria: * Males or females of non-childbearing potential. * Established atherosclerotic cardiovascular disease (ASCVD) (criteria a) or ASCVD risk (criteria b): 1. Age 40 years or older at the time of signing informed consent and history of ASCVD 2. Age above 50 years at the time of...