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

Conditions

• Atherosclerotic Cardiovascular Disease

Eligibility Criteria

Sex

ALL

Age

40 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Aug 3, 2021

Status verified

Jun 2025

Primary completion

Apr 26, 2022

Completion

Jun 20, 2022

Study Design

Enrollment

267 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Oral NNC0385-0434 15 mg once-daily (OD)
  15 mg NNC0385-0434 co-formulated with 500 mg Salcaprozate sodium (SNAC) tablet once daily
• Placebo Comparator: Oral placebo (NNC0385-0434 15 mg)
  15 MG placebo administered as tablets (without SNAC) once daily
• Experimental: Oral NNC0385-0434 40 mg OD
  40 mg study drug co-formulated with 500 mg SNAC tablet once daily
• Placebo Comparator: Oral placebo (NNC0385-0434 40 mg)
  placebo administered as tablets (without SNAC) once daily
• Experimental: Oral NNC0385-0434 100 mg
  100 mg NNC0385-0434 co-formulated with 500 mg SNAC tablet once daily (51 participants)
• Placebo Comparator: Oral placebo (NNC0385-0434 100 mg)
  placebo administered as tablets (without SNAC) once daily
• Active Comparator: Subcutaneous evolocumab 140 mg Q2W
  140 mg evolocumab Subcutaneous (s.c.) injections every 2 weeks (51 participants). The s.c. evolocumab arm is open-label to limit unnecessary injections

Primary Outcome Measure

Percentage Change in Low-density Lipoprotein (LDL)-Cholesterol [ Time Frame: Baseline (week 0), week 12 ]

Locations (13)

Related coverage on Hipa.ai

• Evolocumab 140 mg Shows Strong LDL-C Reduction in ASCVD Trial
  Evolocumab · Jun 8, 2025 · ClinicalTrials.gov

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