Phase 3
Completed N=103
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia
Source: ClinicalTrials.gov NCT01644474 ↗Enrolled (actual)
103
Serious AEs
1.9%
Results posted
Nov 2015
Primary outcomePrimary: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis — -15.6; -47.2 percent change — p=<0.0001
Summary
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).
Primary Objective of the study:
To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia.
Secondary Objectives:
* To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points
* To evaluate the effect of alirocumab on other lipid parameters
* To evaluate the safety and tolerability of alirocumab
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis |
-15.6; -47.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis |
-19.6; -48.1 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24 - ITT Analysis |
-11.0; -36.7 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis |
-15.1; -40.6 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis |
-10.9; -29.6 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo B at Week 12 - ITT Analysis |
-11.7; -37.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis |
-16.7; -42.5 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total-C at Week 12 - ITT Analysis |
-12.0; -30.3 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis |
32.2; 88.1 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis |
2.4; 59.4 | 0.0001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis |
-12.3; -16.7 | 0.4013 |
| SECONDARY Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis |
1.6; 6.0 | — |
| SECONDARY Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis |
1.6; 9.0 | — |
| SECONDARY Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis |
-14.2; -17.2 | — |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis |
-10.8; -11.9 | — |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis |
-2.3; -12.2 | — |
| SECONDARY Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis |
-0.6; 4.7 | — |
| SECONDARY Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis |
-2.2; 2.3 | — |
Eligibility Criteria
Inclusion criteria
- Participants with hypercholesterolemia
Exclusion criteria
- Age 190 mg/dL (> 4.9 mmol/L)
- Fasting serum triglycerides (TG) > 400 mg/dL (> 4.52 mmol/L)
- Known history of homozygous or heterozygous familial hypercholesterolemia
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT01644474). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.