Phase 3
Completed N=2,341
Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)
Source: ClinicalTrials.gov NCT01507831 ↗Enrolled (actual)
2,341
Serious AEs
19.0%
Results posted
Dec 2015
Primary outcomePrimary: Percentage of Participants Who Experienced Adverse Events (AEs) — 82.5; 81.0; 19.5; 18.7 percentage of participants
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 evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT).
Secondary Objectives:
* To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.
* To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points.
* To evaluate the effects of alirocumab on other lipid parameters.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced Adverse Events (AEs) |
82.5; 81.0; 19.5; 18.7; 1.3; 0.5 | — |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis |
0.8; -61.0 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis |
0.7; -62.8 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis |
1.5; -63.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis |
1.4; -64.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Measured LDL-C at Week 24 - ITT Analysis |
3.5; -57.8 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis |
1.2; -52.8 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis |
1.2; -54.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis |
0.7; -51.6 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis |
0.6; -53.1 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis |
-0.3; -37.8 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo B at Week 12 - ITT Analysis |
0.5; -55.5 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis |
0.9; -53.7 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total-C at Week 12 - ITT Analysis |
0.2; -38.8 | <0.0001 sig |
| SECONDARY Percentage of Very High Cardiovascular (CV) Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis |
8.5; 80.7 | <0.0001 sig |
| SECONDARY Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis |
8.5; 82.8 | <0.0001 sig |
| SECONDARY Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis |
8.0; 79.3 | <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; 81.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis |
-3.7; -29.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis |
-0.6; 4.0 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis |
1.8; -15.6 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo A1 at Week 24 - ITT Analysis |
1.2; 4.0 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis |
-3.1; -28.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis |
0.2; 5.8 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis |
1.2; -16.7 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo A1 at Week 12 - ITT Analysis |
0.6; 4.6 | <0.0001 sig |
Eligibility Criteria
Inclusion criteria
Either A or B below and who were not adequately controlled with their lipid-modifying therapy:
A) Participants with heterozygous familial hypercholesterolemia (heFH) with or without established coronary heart disease (CHD) or CHD risk equivalents
OR
B) Participants with hypercholesterolemia together with established CHD or CHD risk equivalents.
Exclusion criteria
- Age 400 mg/dL (>4.52 mmol/L)
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 (NCT01507831). 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.