Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.

• Status: Not yet recruiting
• Trial end date: 2024-10-30
• Target enrollment: 0
• Participant gender: All

Summary

CKJX839D12304 is a research study to determine if the study treatment, called inclisiran, in comparison to placebo or ezetimibe can effectively reduce LDL-C as measured by percentage change from baseline to Day 150. This study is being conducted in eligible participants with primary hypercholesterolemia not receiving any lipid-lowering therapy (LLT), with a 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk of less than 7.5%.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Ezetimibe

Criteria

Inclusion Criteria to be met at screening:

• informed consent must be signed prior to participation in study

• fasting LDL-C of >= 100mg/dL but < 190mg/dL

• fasting triglycerides <= 400 mg/dL

• 10-year ASCVD risk score < 7.5%

• not on any lipid-lowering therapy within 90 days

Key Exclusion Criteria:

• history of ASCVD

• diabetes mellitus or fasting plasma glucose of >= 7.0 mmol/L or HbA1c >= 6.5%

• secondary hypercholesterolemia, e.g. hypothyroidism (TSH above upper limit of normal)

Other protocol-defined inclusion/exclusion criteria may apply.