Established atherosclerotic cardiovascular disease (ASCVD) or ASCVD risk Elevated cholesterol MedDRA version: 21.1 Level: LLT Classification code 10051615 Term: Atherosclerotic cardiovascular disease System Organ Class: 100000004866 MedDRA version: 20.1 Level: PT Classification code 10005425 Term: Blood cholesterol increased System Organ Class: 10022891 - Investigations
Conditions
Interventions
Product Name: NNC0385-0434 A 15 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: N/A
CAS Number: *MASKED*
Other descriptive name: NNC0385-0434
Concentration unit: mg milligram(s)
Concentration type
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male patient or female patient of non-childbearing potential. - Established atherosclerotic cardiovascular disease (ASCVD) (criteria a) or ASCVD risk (criteria b): a)Age greater than or equal to 40 years at the time of signing informed consent and history of ASCVD b)Age greater than 50 years at the time of signing informed consent and with ASCVD risk - Serum LDL-C greater than or equal to1.8 mmol/L (greater than or equal to 70 mg/dL) as measured by the central laboratory at screening. Japanese patients: Serum LDL-C greater than or equal to 2.6 mmol/L (greater than or equal to 100 mg/dL) for patients of greater than or equal to 40 years of age and with a history of coronary heart disease, and serum LDL-C greater than or equal to 3.1 mmol/L (greater than or equal to 120 mg/dL) for all other Japanese patients - Patients must be on maximally tolerated dose of statins. - Patients not receiving statin must have documented evidence of intolerance to all doses of at least two different statins. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 153 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 102
Exclusion criteria
Exclusion criteria: - Treatment with PCSK9i therapy (alirocumab or evolocumab within 90 days prior to screening) or PCSK9 siRNA therapy (inclisiran within 12 months prior to screening). - Fasting triglyceride greater than 4.52 mmol/L (greater than 400 mg/dL) as measured by the central laboratory at screening. - Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening. - Renal impairment with eGFR below 30 ml/min/1.73 m^2 as measured by the central laboratory at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate superiority of three dose levels of oral NNC0385-0434 versus placebo on percent change in LDL-C from baseline to week 12 in patients with established ASCVD or ASCVD risk on maximally tolerated statin dose and other lipid-lowering therapy requiring further LDL-C reduction.;Secondary Objective: To compare the effect on lipid/lipoprotein parameters excluding LDL-C of three dose levels of oral NNC0385-0434 versus placebo in patients with established ASCVD or ASCVD risk on maximally tolerated statin dose and other lipid-lowering therapy requiring further LDL-C reduction. To compare the effect on lipid/lipoprotein parameters of three dose levels of oral NNC0385-0434 versus s.c. evolocumab in patients with established ASCVD or ASCVD risk on maximally tolerated statin dose and other lipid-lowering therapy requiring further LDL-C reduction. To compare the safety and tolerability of three dose levels of oral NNC0385-0434 versus placebo in patients with established ASCVD or ASCVD risk on maximally tolerated statin dose and other lipid-lowering therapy requiring further LDL-C reduction.;Primary end point(s): 1. Change in LDL-cholesterol;Timepoint(s) of evaluation of this end point: From baseline (week 0) to visit 9 (week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in total cholesterol 2. Change in HDL-cholesterol 3. Change in VLDL-cholesterol 4. Change in triglycerides 5. Change in total Apo B 6. Change in total Apo CIII 7. Change in total Lp(a) 8. Treatment-emergent adverse events;Timepoint(s) of evaluation of this end point: 1.-7. From baseline (week 0) to visit 9 (week 12) 8. From baseline (week 0) to visit 10 (19 weeks + 4 days) | — |
Countries
Belgium, European Union, Germany, Greece, Japan, Netherlands, Poland, United States
Contacts
Public ContactClinical Transparency (1452)
Novo Nordisk A/S
Outcome results
None listed