Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C

• Status: Active, not recruiting
• Trial end date: 2022-12-23
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to assess the efficacy and safety of inclisiran in Japanese participants with an increased LDL-C concentrations. The study also evaluates the pharmacokinetics of inclisiran in a subset of Japanese participants.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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.

Other protocol-defined inclusion/exclusion criteria may apply.