Study of efficacy and safety of inclisiran in Japanese participants with high cardiovascular risk and elevated LDL-C

JRCT ID: jRCT2031200313

Registered date:19/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia
• Date of first enrollment: 29/01/2021
• Target sample size: 308
• Study type: Interventional

Intervention(s)

Arm1. 300 mg inclisiran sodium Subcutaneous injection
Arm2. 200 mg inclisiran sodium Subcutaneous injection
Arm3. 100 mg inclisiran sodium Subcutaneous injection
Arm4. Placebo Subcutaneous injection

Outcome(s)

• Primary Outcome: Superiority of inclisiran treatment at different dose levels (100 mg, 200 mg, and 300 mg) to placebo on LDLC levels at Day 180

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Yamada Hiroyuki
• Secondary ID(s): NCT04666298