Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
Launched by NOVARTIS PHARMACEUTICALS · Feb 28, 2023
Trial Information
Current as of June 30, 2025
Completed
Keywords
ClinConnect Summary
This study is a randomized, double-blind, placebo- and active comparator-controlled, multicenter study in 300 adult participants with primary hypercholesterolemia not receiving any LLT with a 10-year ASCVD risk score of less than 7.5%. This study will evaluate the efficacy and safety of inclisiran sodium 300 mg, administered as a monotherapy in comparison to ezetimibe and placebo.
The study consists of:
* a screening period of up to 14 days;
* a double-blind treatment period of 150+/- 5 days during which participants will be randomly assigned to either the inclisiran arm, the ezetimibe ar...
Gender
ALL
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.
About Novartis Pharmaceuticals
Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Vista, California, United States
Fargo, North Dakota, United States
Nashville, Tennessee, United States
Birmingham, Alabama, United States
Bochum, , Germany
Maitland, Florida, United States
Hamburg, , Germany
Sugar Land, Texas, United States
Balatonfured, , Hungary
Budapest, , Hungary
Morton, Illinois, United States
Nyiregyhaza, , Hungary
Bossier City, Louisiana, United States
Miami Lakes, Florida, United States
Richmond, Virginia, United States
Deland, Florida, United States
Lufkin, Texas, United States
Richmond, Virginia, United States
Floridablanca, Santander, Colombia
Berlin, , Germany
Loehne, , Germany
Papenburg, , Germany
Queretaro, , Mexico
Pecs, , Hungary
Shreveport, Louisiana, United States
Zachary, Louisiana, United States
Jerichow, , Germany
West Bend, Wisconsin, United States
Miami, Florida, United States
Hannover, Niedersachsen, Germany
Merida, Yucatan, Mexico
North Miami Beach, Florida, United States
Monroe, North Carolina, United States
San Gil, , Colombia
Monterrey, Nuevo Leon, Mexico
Deland, Florida, United States
Culiacan Sinaloa, , Mexico
Atlanta, Georgia, United States
Dothan, Alabama, United States
North Miami Beach, Florida, United States
Sugar Land, Texas, United States
Dothan, Alabama, United States
Bronx, New York, United States
Birmingham, Alabama, United States
Atlanta, Georgia, United States
Gladbeck, , Germany
Plant City, Florida, United States
Maitland, Florida, United States
Zephyrhills, Florida, United States
Bronx, New York, United States
Morton, Illinois, United States
West Bend, Wisconsin, United States
Muenchen, Bavaria, Germany
Huber Heights, Ohio, United States
Edmond, Oklahoma, United States
Barranquilla, Atlantico, Colombia
Manizales, , Colombia
Miami Lakes, Florida, United States
Miami, Florida, United States
Plant City, Florida, United States
Zephyrhills, Florida, United States
Bossier City, Louisiana, United States
Shreveport, Louisiana, United States
Zachary, Louisiana, United States
Monroe, North Carolina, United States
Fargo, North Dakota, United States
Huber Heights, Ohio, United States
Edmond, Oklahoma, United States
Nashville, Tennessee, United States
Vista, California, United States
Fargo, North Dakota, United States
Zachary, Louisiana, United States
Patients applied
Trial Officials
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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