Phase 3
Completed N=314
Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)
Source: ClinicalTrials.gov NCT01709513 ↗Enrolled (actual)
314
Serious AEs
9.3%
Results posted
Aug 2015
Primary outcomePrimary: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent--To-Treat (ITT) Analysis — -14.6; -45.0 percent change — p=<0.0001
Summary
This is a randomized, double-blind, double-dummy, active-controlled, parallel-group, multi-national, multi-center study to compare alirocumab (REGN727/SAR236553) versus ezetimibe in participants with primary hypercholesterolemia and moderate, high, or very high CV risk, who are intolerant to statins. An atorvastatin arm is added to determine that the population selected in the study is a truly statin intolerant population by assessing skeletal muscle-related adverse events.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent--To-Treat (ITT) Analysis |
-14.6; -45.0 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 24 - On--Treatment Analysis |
-17.1; -52.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL--C at Week 12 -- ITT Analysis |
-15.6; -47.0 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 12 - On--Treatment Analysis |
-18.0; -51.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 -- ITT Analysis |
-11.2; -36.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo B at Week 24 -- On--Treatment Analysis |
-14.4; -42.6 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non--High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 -- ITT Analysis |
-14.6; -40.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non--HDL-C at Week 24 -- On--Treatment Analysis |
-17.1; -46.9 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol (Total--C) at Week 24 - ITT Analysis |
-10.9; -31.8 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo B at Week 12 -- ITT Analysis |
-11.6; -36.1 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis |
-15.8; -41.5 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total-C at Week 12 - ITT Analysis |
-11.6; -32.7 | <0.0001 sig |
| SECONDARY Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or Moderate or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis |
4.4; 41.9 | <0.0001 sig |
| SECONDARY Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or Moderate or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis |
5.6; 51.2 | <0.0001 sig |
| SECONDARY Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis |
0.8; 32.5 | <0.0001 sig |
| SECONDARY Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis |
0.8; 39.0 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis |
-7.3; -25.9 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis |
6.8; 7.7 | =0.6997 |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis |
-3.6; -9.3 | — |
| SECONDARY Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis |
2.9; 4.8 | — |
| SECONDARY Percent Change From Baseline in Lipoprotein(a) at Week 12 -- ITT Analysis |
-4.5; -21.7 | — |
| SECONDARY Percent Change in HDL-C From Baseline to Week 12 -- ITT Analysis |
7.6; 9.0 | — |
| SECONDARY Percent Change in Fasting Triglycerides From Baseline to Week 12 -- ITT Analysis |
-9.4; -8.0 | — |
| SECONDARY Percent Change From Baseline in Apo A--1 at Week 12 -- ITT Analysis |
3.9; 5.5 | — |
Eligibility Criteria
Inclusion:
- Patients with primary hypercholesterolemia [Heterozygous Familial Hypercholesterolemia (heFH) or non-FH] with moderate, high or very high CV risk and a history of statin intolerance
- Provide signed informed consent
Exclusion:
- Calculated serum LDL-C <70 mg/dL (1.81 mmol/L) and very high CV risk at the screening visit
- Calculated serum LDL-C <100 mg/dL (2.59 mmol/L) and high or moderate CV risk at the screening visit
- A 10-year fatal cardiovascular disease risk score <1% at the screening visit
(The inclusion/ exclusion criteria provided above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial).
Data sourced from ClinicalTrials.gov (NCT01709513). 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.