Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy. (V-Mono)
Hypercholesterolemia
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring inclisiran, ezetimibe, LDL-C, monotherapy, primary hypercholesterolemia
Eligibility 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.
Sites / Locations
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative Site
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Placebo Comparator
Inclisiran
Ezetimibe
Placebo
Inclisiran s.c and Placebo p.o
Placebo s.c. and Ezetimibe p.o.
Placebo s.c. and Placebo p.o.