A Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Effect of Different Doses of Inclisiran Given as Subcutaneous Injections in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C

CKJX839A11201

This was a placebo-controlled, double-blind, randomized trial in Japanese participants with history of coronary artery disease (CAD) or participants categorized in 'high risk' by JAS 2017 guideline, or Japanese participants with heterozygous familial hypercholesterolemia (HeFH) and elevated Low-density lipoprotein cholesterol (LDL-C) despite maximum tolerated dose of statin(s) to evaluate the efficacy, safety, tolerability, and PK of subcutaneous inclisiran injection(s).

2021-01-29

2022-04-18

2022-10-19

Completed

Early phase I

312

Inclusion Criteria: * Participants with history of CAD or participants categorized in 'high risk' by Japan Atherosclerosis Society (JAS) 2017 guidelines or participants with heterozygous familial hypercholesterolemia (HeFH) * As per the JAS 2017 guideline, participants not meeting the LDL-C management targets. * Participants on statins should be receiving a maximally tolerated dose. * Participants not receiving statins must have documented evidence of intolerance to at least one statin. * The lipid-lowering therapy should have remained stable for ≥ 30 days before screening with no planned medication/ dose change until Day 180 Exclusion Criteria: * Participants diagnosed with homozygous familial hypercholesterolemia (HoFH). * Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9. * New York Heart Association (NYHA) class IV heart failure or last known left ventricular ejection fraction \<25%. * Cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation. * Uncontrolled hypertension: systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg prior to randomization despite antihypertensive therapy. * Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), \>3x the upper limit of normal (ULN), or total bilirubin \>2x ULN at screening. * Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 312, 'type': 'ACTUAL'}}

2023-05-10