Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
Sponsored by Novartis Pharmaceuticals
About this trial
Last updated 2 years ago
Study ID
CKJX839D12304
Status
Recruiting
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
18 to 75 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 10 months ago
What is this trial about?
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%.
What are the Participation Requirements?
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.