Phase 3
Completed N=216
Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN)
Source: ClinicalTrials.gov NCT02107898 ↗Enrolled (actual)
216
Serious AEs
8.8%
Results posted
Jan 2016
Primary outcomePrimary: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT Analysis) — 1.6; -62.5 percent change — p=<0.0001
Summary
Primary Objective:
To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable daily statin therapy with or without other lipid modifying therapy in comparison with placebo after 24 weeks of treatment in heterozygous familial hypercholesterolemia (HeFH) or high cardiovascular risk participants with hypercholesterolemia.
Secondary Objectives:
* To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks of treatment.
* To evaluate the effect of alirocumab on other lipid parameters.
* To evaluate the long-term effect of alirocumab in comparison with placebo on LDL-C after 52 weeks of treatment.
* 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 24 - Intent-to-Treat (ITT Analysis) |
1.6; -62.5 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis |
1.7; -63.7 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis |
-2.7; -64.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis |
-2.8; -64.8 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis |
-1.6; -55.0 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis |
-2.1; -55.9 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis |
2.6; -54.9 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis |
2.6; -56.0 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis |
2.0; -39.5 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo B at Week 12 - ITT Analysis |
-3.3; -54.6 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis |
-1.7; -56.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total-C at Week 12 - ITT Analysis |
-2.1; -41.1 | <0.0001 sig |
| SECONDARY Percentage of Participants Reaching Calculated LDL-C Goal at Week 24 - ITT Analysis |
10.2; 96.7 | <0.0001 sig |
| SECONDARY Percentage of Participants Reaching Calculated LDL-C Goal at Week 24 - On-Treatment Analysis |
10.6; 97.9 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis |
2.5; -39.5 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis |
6.7; -15.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis |
2.1; 7.9 | 0.0020 sig |
| SECONDARY Percent Change From Baseline in Apo A1 at Week 24 - ITT Analysis |
-2.6; 1.4 | 0.0382 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis |
-0.5; -41.9 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis |
2.4; -13.1 | 0.0007 sig |
| SECONDARY Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis |
-1.8; 4.7 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo A1 at Week 12 - ITT Analysis |
-4.8; 1.5 | <0.0001 sig |
Eligibility Criteria
Inclusion criteria
Participants with heterozygous familial hypercholesterolemia or non-familial hypercholesterolemia who were not adequately controlled with a stable daily dose of statin with or without other lipid modifying therapy, at stable dose prior to the screening visit (Week -3).
Exclusion criteria
- LDL-C <100 mg/dL (<2.59 mmol/L) at the screening visit in participants with heterozygous familial hypercholesterolemia or in participants with non-familial hypercholesterolemia who had a history of documented coronary heart disease as described in Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
- LDL-C <120 mg/dL (<3.10 mmol/L) at the screening visit in participants with non-familial hypercholesterolemia who had a history of documented diseases or other risk factors as categorized in primary prevention category III as described in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
- Not on a stable daily dose of lipid modifying therapy (including statin) within 4 weeks prior to the screening visit or between screening and randomization visits.
- Age <20 years at the screening visit.
The above information is not intended to contain all considerations relevant to a participants' potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT02107898). 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.