Phase 3
Completed N=316
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I)
Source: ClinicalTrials.gov NCT01644175 ↗Enrolled (actual)
316
Serious AEs
12.7%
Results posted
Nov 2015
Primary outcomePrimary: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis — -2.3; -48.2 percent change — p=<0.0001
Summary
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9).
Primary Objective of the study:
* To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy with or without other lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in high cardiovascular (CV) risk participants with hypercholesterolemia
Secondary Objectives:
* To evaluate the effect of alirocumab in comparison with placebo 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 |
-2.3; -48.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis |
-0.8; -50.7 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis |
1.1; -46.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis |
1.7; -47.6 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis |
-0.9; -36.7 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis |
-0.4; -37.9 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis |
-1.6; -39.1 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis |
-0.5; -40.9 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis |
-2.9; -27.9 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo B at Week 12 - ITT Analysis |
3.4; -34.8 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis |
2.6; -37.4 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total-C at Week 12 - ITT Analysis |
0.9; -25.4 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis |
0.5; -42.5 | <0.0001 sig |
| SECONDARY Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis |
9.0; 75.0 | <0.0001 sig |
| SECONDARY Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-treatment Analysis |
8.0; 77.5 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis |
-5.9; -20.5 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis |
-3.8; 3.5 | 0.0001 sig |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis |
-5.4; -6.0 | 0.8699 |
| SECONDARY Percent Change From Baseline in Apolipoprotein A-1 at Week 24 - ITT Analysis |
-2.5; 3.3 | — |
| SECONDARY Percent Change From Baseline in Lipoprotein(a) at Week 12- ITT Analysis |
0.0; -19.7 | — |
| SECONDARY Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis |
-2.4; 6.7 | — |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis |
3.0; -11.3 | — |
| SECONDARY Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis |
-1.8; 3.8 | — |
Eligibility Criteria
Inclusion criteria
- Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who were not adequately controlled with a maximally tolerated daily dose of statin with or without other LMT, both at stable dose for at least 4 weeks to 6 weeks prior to screening (Week -2)
Exclusion criteria
- Age 400 mg/dL (>4.52 mmol/L)
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 (NCT01644175). 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.