Patients with primary hypercholesterolemia and moderate, high or very high cardiovascular (CV) risk who are intolerant to statins MedDRA version: 14.1 Level: PT Classification code 10020603 Term: Hypercholesterolaemia System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: REGN727/SAR236553
Product Code: REGN727
Pharmaceutical Form: Solution for injection
INN or Proposed INN: REGN727
CAS Number: 1245916-14-6
Current Sponsor code: REGN727 (SAR236553)
Other
Sponsors
Regeneron Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with primary hypercholesterolemia (heFH* or non-FH) with moderate, high or very high CV risk** and a history of statin intolerance*** * Diagnosis of heFH must be made either by genotyping or by clinical criteria. For patients who are not genotyped, the clinical diagnosis must be a certain/definite diagnosis and may be based on either the Simon Broome criteria or the WHO/Dutch Lipid Network criteria. ** Moderate, high, and very high CV risk as defined in section 4.2. *** Definition of statin intolerance: Inability to tolerate at least 2 previous statins at the lowest approved daily dose due to skeletal muscle-related symptoms, other than those due to strain or trauma, such as pain, aches, weakness, or cramping, that began or increased during statin therapy and stopped when statin therapy was discontinued. 2. Provide signed informed consent 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 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Calculated serum LDL-C 10,000 IU/L)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate the reduction of low-density lipoprotein (LDL) cholesterol (LDL-C) by REGN727 in comparison with ezetimibe (EZE) 10 mg PO QD after 24 weeks in patients with primary hypercholesterolemia (heterozygous familial hypercholesterolemia [heFH] and non-familial hypercholesterolemia [FH]) who are intolerant to statins.;Secondary Objective: - To evaluate the effect of REGN727 75 mg in comparison with EZE on LDL-C after 12 weeks of treatment - To evaluate the effect of REGN727 on other lipid parameters (ie, ApoB, non-HDL-C, total-C, Lp(a), HDL-C, TG levels, and ApoA-1 levels) - To evaluate the safety and tolerability of REGN727, including the characterization of the incidence rate and treatment withdrawal rate of skeletal muscle-related adverse events (AEs) - To evaluate the development of anti-REGN727 antibodies;Primary end point(s): The percent change in calculated LDL-C. ;Timepoint(s) of evaluation of this end point: From baseline to week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The percent change in calculated LDL-C from baseline to week 12 - The percent change in ApoB from baseline to week 24. - The percent change in non-HDL-C from baseline to week 24. - The percent change in total-C from baseline to week 24. - The percent change in ApoB from baseline to week 12. - The percent change in non-HDL-C from baseline to week 12. - The percent change in total-C from baseline to week 12. - The proportion of patients reaching LDL-C goal at week 24, ie, LDL-C <70 mg/dL (1.81 mmol/L) in case of very high CV risk or LDL-C <100 mg/dL (2.59 mmol/L) for patients with moderate or high CV risk. - The proportion of patients reaching LDL-C <70 mg/dL (1.81 mmol/L) at week 24 - The percent change in Lp(a) from baseline to week 24. - The percent change in HDL-C from baseline to week 24. - The percent change in HDL-C from baseline to week 12. - The percent change in Lp(a) from baseline to week 12. - The percent change in fasting TG from baseline to week 24. - The percent change in fasting TG from baseline to week 12. - The percent change in ApoA-1 from baseline to week 24. - The percent change in ApoA-1 from baseline to week 12.;Timepoint(s) of evaluation of this end point: from baseline to weeks 12 and 24 | — |
Countries
Austria, Canada, France, Germany, Italy, Netherlands, Norway, United Kingdom, United States
Contacts
Public ContactDan Gipe, MD
Regeneron Pharmaceuticals, Inc.
Outcome results
None listed