Clareo Health | 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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novo Nordisk A/S
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 signing informed consent and with ASCVD risk
Serum LDL-C above or equal to 1.8 mmol/L (above or equal to 70 mg/dL) as measured by the central laboratory at screening.
Japanese participants: Serum LDL-C above or equal to 2.6 mmol/L (above or equal to 100 mg/dL) for participants of 40 years of age or older and with a history of coronary heart disease, and serum LDL-C above or equal to 3.1 mmol/L (above or equal to 120 mg/dL) for all other Japanese participants
Participants must be on maximally tolerated dose of statins.
Participants not receiving statin must have documented evidence of intolerance to all doses of at least two different statins.
You may not be if
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 above 4.52 mmol/L (above 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 less than 30 ml/min/1.73 m2 as measured by the central laboratory at screening
