Phase 3
Completed N=355
Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)
Source: ClinicalTrials.gov NCT01730040 ↗Enrolled (actual)
355
Serious AEs
5.4%
Results posted
Aug 2015
Primary outcomePrimary: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis — -5; -20.5; -44.1; -4.8 percent change — p=< 0.0001
Summary
This is a randomized, double-blind, active-comparator, parallel-group study in patients at high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial hypercholesterolemia (heFH).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis |
-5; -20.5; -44.1; -4.8; -21.4; -22.6 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis |
-6.1; -23.7; -48.6; -5.0; -22.9; -24.5 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis |
-8.5; -22.6; -48.4; -14.5; -23.3; -29.7 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis |
-9.2; -27.1; -53.7; -14.6; -23.3; -30.7 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis |
-4.4; -10.1; -33.7; -3.5; -10.9; -14.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis |
-5.1; -12.6; -37.7; -4.4; -12.8; -16.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis |
-6.3; -15.1; -36.7; -6.5; -17.4; -21.0 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis |
-7.5; -18.1; -40.5; -7.0; -18.4; -23.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis |
-4.0; -11.2; -27.1; -4.8; -11.7; -15.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo B at Week 12 - ITT Analysis |
-6.9; -13.1; -38.4; -9.5; -14.1; -20.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis |
-7.1; -17.2; -40.6; -13.0; -19.8; -27.5 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total-C at Week 12 - ITT Analysis |
-6.5; -13.2; -29.0; -9.9; -13.5; -19.2 | <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 - ITT Analysis |
34.5; 68.4; 87.2; 18.5; 62.2; 65.1 | <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 |
37.8; 72.2; 91.2; 18.5; 64.0; 66.2 | <0.0001 sig |
| SECONDARY Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis |
16.0; 50.3; 79.2; 10.2; 42.2; 54.2 | <0.0001 sig |
| SECONDARY Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis |
20.0; 55.1; 82.3; 10.5; 42.4; 55.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis |
-20.2; -10.6; -23.6; -9.7; -4.9; 0.2 | =0.0004 sig |
| SECONDARY Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis |
1.9; -0.1; 4.8; 4.7; 5.7; 2.0 | =0.4456 |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis |
-6.7; -3.3; -12.0; -7.3; -0.5; -13.9 | — |
| SECONDARY Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis |
1.2; 1.0; 7.6; 2.2; 4.7; -1.8 | — |
| SECONDARY Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis |
-11.7; -5.4; -24.0; -1.6; 11.5; 7.9 | — |
| SECONDARY Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis |
-3.2; -1.7; 4.1; 3.0; 4.6; 4.6 | — |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis |
-4.7; 0.5; -12.4; -4.6; -3.7; -16.8 | — |
| SECONDARY Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis |
-0.8; 1.7; 5.4; 1.6; 5.6; 1.6 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with screening (visit 1) LDL-C greater than or equal to 70 mg/dL with documented CVD, not adequately controlled with a daily dose of atorvastatin. OR
- Patients with screening (visit 1) LDL-C greater than or equal to 100 mg/dL at high risk for CVD who are not adequately controlled with a daily dose of atorvastatin.
Exclusion Criteria
- LDL-C greater than 250 mg/dL
- LDL-C less than 70 mg/dL at the screening visit in patients with history of documented CVD
- LDL-C less than 100 mg/dL at the screening visit in patients without history of documented CHD or non-CHD CVD, but with other risk factors
- TG greater than 400 mg/dL
- Homozygous FH (clinically or previous genotyping)
- Currently taking a statin that is not atorvastatin
- Currently taking Ezetimibe (EZE)
- Not on a stable dose of allowable lipid modifying treatments (LMT)
(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 (NCT01730040). 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.