Hypercholesterolemia MedDRA version: 21.0 Level: LLT Classification code 10020604 Term: Hypercholesterolemia System Organ Class: 100000004861
Conditions
Interventions
Product Name: Inclisiran for Injection
Product Code: Inclisiran for Injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Inclisiran
Current Sponsor code: Inclisiran sodium
Other
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Completion of study MDCO-PCS-15-01 and no contraindications to receiving inclisiran or evolocumab. 2. Willing and able to give informed consent before initiation of any study-related procedures and willing to comply with all required study procedures. 3. Willing to self-inject. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 198 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 184
Exclusion criteria
Exclusion criteria: 1. Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study, and/or put the subject at significant risk (according to investigator’s [or delegate’s] judgment) if he/she participates in the clinical study. 2. An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results. 3. Serious comorbid disease in which the life expectancy of the subject is shorter than the duration of the trial (eg, acute systemic infection, cancer, or other serious illnesses). 4. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained alanine aminotransferase (ALT), aspartate aminotransferase (AST), elevation >2x the upper limit of normal (ULN), or total bilirubin elevation >1.5x ULN at Study Entry visit, confirmed by a repeat abnormal measurement at least 1 week apart. 5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least two methods of contraception (eg, oral contraceptives, barrier methods, approved contraceptive implant, long- term injectable contraception, intrauterine device or tubal ligation) for the entire duration of the trial. Women who are >2 years postmenopausal defined as =1 year since last menstrual period AND if less than 55 years old with a negative pregnancy test within 24 hours of entry into the study or surgically sterile are exempt. Exemptions from this exclusion.criterion: a. Women >2 years postmenopausal (defined as 1 year or longer since their last menstrual period) AND more than 55 years of age b. Postmenopausal women (as defined above) and less than 55 years old with a negative pregnancy test within 24 hours of enrollment c. Women who are surgically sterilized at least 3 months prior to enrollment 6. Males who are unwilling to use an acceptable method of birth control during the entire study period (ie, condom with spermicide). 7. Treatment with investigational medicinal products other than inclisiran or devices within 30 days or five half/lives, whichever is longer. 8. Planned use of other investigational medicinal products other than inclisiran or devices during the course of the study. 9. Subjects with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients. 10. Previous or current treatment (within 90 days of study entry) with monoclonal antibodies directed towards PCSK9. 11. Any condition that according to the investigator could interfere with the conduct of the study, such as but not limited to: a. Inappropriate for this study, including subjects who are unable to communicate or to cooperate with the investigator. b. Unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study (including subjects whose cooperation is doubtful due to drug abuse or alcohol dependency). c. Unlikely to comply with the protocol requirements, instructions, and study-related restrictions (eg, uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study). d. Involved with, or a relative of, someone directly involved in the conduct of the study. e. Any known cognitive impairment (eg, Alzheimer’s disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of inclisiran treatment on low density lipoprotein cholesterol (LDL-C) levels at Day 210 compared to Baseline of ORION-1 in Group 1 (inclisiran only arm).;Secondary Objective: • To evaluate the effects of inclisiran on the following (Group 1; inclisiran only arm): - LDL-C levels over time - PCSK9 levels over time - Other lipids, lipoproteins, and apolipoproteins over time - Proportion of subjects achieving target levels prespecified in global lipid guidelines - Proportion of subjects at least 50% LDL-C reduction from Baseline of ORION-1 over time - Individual responsiveness to inclisiran • To evaluate the long term safety and tolerability of inclisiran (Group 1; inclisiran only arm);Primary end point(s): Primary Endpoint (Group 1; inclisiran only arm): • Percentage change from Baseline of ORION-1 in LDL-C at Day 210 in this study (Group 1; inclisiran only arm) ;Timepoint(s) of evaluation of this end point: Included in previous section. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints (Group 1; Inclisiran Only Arm): • Change and percentage change from Baseline of ORION-1 in LDL-C over time in this study • Change and percentage change from Baseline of ORION-1 in PCSK9 levels over time in this study • Change and percentage change from Baseline of ORION-1 in other lipids, lipoproteins, and apolipoproteins over time in this study • Proportion of subjects with =50% LDL-C reduction from Baseline of ORION-1 at each time point • Individual responsiveness to inclisiran defined as the number of subjects reaching on treatment LDL-C levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL at any time point • Change and percentage change in LDL-C at Day 210 compared to Day 870 of ORION-3 • Long term safety and tolerability of inclisiran treatment;Timepoint(s) of evaluation of this end point: Included in previous section | — |
Countries
Canada, Germany, Netherlands, United Kingdom, United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed