Phase 2
Completed N=183
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy
Source: ClinicalTrials.gov NCT01288443 ↗Enrolled (actual)
183
Serious AEs
2.2%
Results posted
Sep 2015
Primary outcomePrimary: Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis — -5.1; -39.6; -64.2; -72.4 percent change — p=<0.0001
Summary
Primary Objective:
* To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels after 12 weeks of treatment in comparison with placebo in participants with LDL-C ≥ 100 mg/dL (≥ 2.59 mmol/L) on ongoing stable atorvastatin therapy.
Secondary Objectives:
* To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment in comparison with placebo
* To evaluate the safety and tolerability of alirocumab
* To evaluate the development of anti-alirocumab antibodies
* To evaluate the pharmacokinetics of alirocumab
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis |
-5.1; -39.6; -64.2; -72.4; -43.2; -47.7 | <0.0001 sig |
| SECONDARY Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 12 - On-Treatment Analysis |
-0.20; -1.37; -2.10; -2.38; -1.46; -1.62 | — |
| SECONDARY Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 12 - On-Treatment Analysis |
-7.6; -53.0; -81.2; -92.0; -56.4; -62.5 | — |
| SECONDARY Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and <70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis |
16.1; 93.3; 96.8; 100.0; 89.3; 96.7 | — |
| SECONDARY Percent Change From Baseline in Total Cholesterol, High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis |
-1.6; -23.0; -39.7; -45.2; -28.0; -29.8 | — |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides and Lipoprotein(a) at Week 12 - On-Treatment Analysis |
9.7; -6.6; -5.5; -18.9; -10.8; -8.4 | — |
| SECONDARY Absolute Change in the Ratio Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) From Baseline to Week 12 - On-Treatment Analysis |
0.05; -0.23; -0.35; -0.42; -0.23; -0.29 | — |
Eligibility Criteria
Inclusion criteria
- Participants with primary hypercholesterolemia receiving a lipid-lowering treatment other than atorvastatin or not at stable dose of atorvastatin 10 mg, 20 mg, or 40 mg for at least 6 weeks prior to screening period or drug naive participants if they are likely to have low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL (≥ 2.59 mmol/L) at the end of the 6-week run-in treatment period on atorvastatin therapy
OR
- Participants with primary hypercholesterolemia treated with atorvastatin at stable dose of 10 mg, 20 mg, or 40 mg for at least 6 weeks prior to screening period and likely to have LDL-C ≥ 100 mg/dL (≥ 2.59 mmol/L) at the screening visit
Exclusion criteria
- LDL-C 350 mg/dL (> 3.95 mmol/L) at screening visit
- Positive serum or urine pregnancy test in females of childbearing potential
- Pregnant or breast-feeding women
- Women of childbearing potential with no effective contraceptive method
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT01288443). 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.