Phase 3
Completed N=803
Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)
Source: ClinicalTrials.gov NCT01926782 ↗Enrolled (actual)
803
Serious AEs
12.3%
Results posted
Mar 2017
Primary outcomePrimary: Percent Change From Baseline in Calculated LDL-C in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis — -0.3; -50.2; -52.7; -1.6 percent change — p=<0.0001
◆ Published Evidence
Highly cited
124citations · ~12 / year
A phase III randomized trial evaluating alirocumab 300 mg every 4 weeks as monotherapy or add-on to statin: ODYSSEY CHOICE I.
Summary
To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4 weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen. The dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a calibrator.
Linked Publications (3)
-
A phase III randomized trial evaluating alirocumab 300 mg every 4 weeks as monotherapy or add-on to statin: ODYSSEY CHOICE I.
-
Pharmacodynamic relationship between PCSK9, alirocumab, and LDL-C lowering in the ODYSSEY CHOICE I trial.
-
Efficacy and Safety of Alirocumab 300 mg Every 4 Weeks in Individuals With Type 2 Diabetes on Maximally Tolerated Statin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Calculated LDL-C in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis |
-0.3; -50.2; -52.7; -1.6; -54; -56.9 | <0.0001 sig |
| PRIMARY Percent Change From Baseline in Calculated LDL-C in Participants Receiving Concomitant Statin Therapy - Intent-to-Treat (ITT Analysis) |
-0.1; -51.6; -58.8; 0.8; -57.9; -65.8 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 24 in Participants Not Receiving Concomitant Statin Therapy - On-Treatment Analysis |
-0.4; -54.6; -59.4 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 24 in Participants Receiving Concomitant Statin Therapy - On-Treatment Analysis |
-0.3; -55.1; -62.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis |
0.3; -51.8; -58.4 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Receiving Concomitant Statin Therapy - ITT Analysis |
1.1; -45.3; -55.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - On-treatment Analysis |
-0.5; -53.9; -60.0 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Receiving Concomitant Statin Therapy - On-treatment Analysis |
1.4; -47.3; -58.0 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis |
-0.7; -39.0; -40.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo B at Week 24 in Participants Receiving Concomitant Statin Therapy - ITT Analysis |
3.1; -36.7; -45.1 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo B at Week 24 in Participants Not Receiving Concomitant Statin Therapy - On-Treatment Analysis |
-0.3; -42.0; -44.8 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo B at Week 24 in Participants Receiving Concomitant Statin Therapy - On-Treatment Analysis |
3.1; -38.3; -47.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis |
-0.3; -43.6; -43.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 24 in Participants Receiving Concomitant Statin Therapy - ITT Analysis |
0.3; -41.6; -49.7 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 24 in Participants Not Receiving Concomitant Statin Therapy - On-Treatment Analysis |
0.1; -47.2; -48.9 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 24 in Participants Receiving Concomitant Statin Therapy - On-Treatment Analysis |
0.2; -44.4; -52.6 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis |
-1.9; -32.5; -33.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total-C at Week 24 in Participants Receiving Concomitant Statin Therapy - ITT Analysis |
-0.8; -30.0; -35.8 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo B at Week 12 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis |
-2.3; -40.8; -46.4 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo B at Week 12 in Participants Receiving Concomitant Statin Therapy - ITT Analysis |
3.6; -33.0; -41.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis |
-0.4; -45.8; -49.9 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 12 in Participants Receiving Concomitant Statin Therapy - ITT Analysis |
0.6; -37.4; -46.5 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis |
-1.0; -33.4; -37.4 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total-C at Week 12 in Participants Receiving Concomitant Statin Therapy - ITT Analysis |
-0.1; -26.5; -32.9 | <0.0001 sig |
| SECONDARY Percentage of Very High CV Risk Participants Reaching Calculated LDL-C<70 mg/dL or Moderate or High CV Risk Participants Reaching Calculated LDL-C<100 mg/dL (Without Concomitant Statin Therapy) at Week 24 - ITT Analysis |
9.4; 84.9; 78.9 | <0.0001 sig |
| SECONDARY Percentage of Very High Cardiovascular (CV) Risk Participants Reaching Calculated LDL-C <70 mg/dL or Moderate or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (With Concomitant Statin Therapy) at Week 24 - ITT Analysis |
22.2; 82.5; 85.2 | <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) (Without Concomitant Statin Therapy) at Week 24 - On-Treatment Analysis |
11.3; 93.0; 88.6 | <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) (With Concomitant Statin Therapy) at Week 24 - On-Treatment Analysis |
22.5; 86.4; 89.5 | <0.0001 sig |
| SECONDARY Percentage of Participants (Without Concomitant Statin Therapy) Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis |
3.3; 57.7; 62.0 | <0.0001 sig |
| SECONDARY Percentage of Participants (With Concomitant Statin Therapy) Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis |
10.9; 74.4; 80.4 | <0.0001 sig |
| SECONDARY Percentage of Participants (Without Concomitant Statin Therapy) Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis |
2.1; 61.7; 70.4 | <0.0001 sig |
| SECONDARY Percentage of Participants (With Concomitant Statin Therapy) Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis |
10.8; 77.4; 84.8 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein (a) in Participants Not Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis |
6.4; -14.0; -21.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein (a) in Participants Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis |
9.8; -16.9; -19.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein (a) in Participants Not Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis |
-5.5; -26.9; -28.9 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein (a) in Participants Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis |
7.0; -12.4; -19.6 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in HDL-C in Participants Not Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis |
-5.3; -0.1; 2.5 | 0.0003 sig |
| SECONDARY Percent Change From Baseline in HDL-C in Participants Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis |
-1.5; 6.0; 3.6 | 0.0004 sig |
| SECONDARY Percent Change From Baseline in HDL-C in Participants Not Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis |
-0.9; 2.5; 6.0 | 0.0004 sig |
| SECONDARY Percent Change From Baseline in HDL-C in Participants Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis |
0.4; 7.6; 5.7 | 0.0007 sig |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides in Participants Not Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis |
-1.5; -9.8; -13.4 | 0.0042 sig |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides in Participants Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis |
-0.1; -6.7; -15.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides in Participants Not Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis |
1.8; -18.3; -12.3 | 0.0004 sig |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides in Participants Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis |
0.5; -7.3; -13.1 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo A1 in Participants Not Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis |
-1.4; 3.1; 5.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo A1 in Participants Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis |
2.9; 6.5; 5.5 | 0.0306 sig |
| SECONDARY Percent Change From Baseline in Apo A1 in Participants Not Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis |
-1.8; 2.4; 4.6 | — |
| SECONDARY Percent Change From Baseline in Apo A1 in Participants Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis |
2.7; 6.1; 6.0 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women > age 18 or legal age of majority with elevated LDL-C
- Patients not having adequate control of their hypercholesterolemia based on their individual level of CVD risk
- Willing and able to comply with clinic visits and study-related procedures
- Provided signed informed consent
Exclusion Criteria
- Recent (within 3 months prior to the screening visit) myocardial infarction, unstable angina leading to hospitalization, percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease
- Known history of positive test for human immunodeficiency virus (HIV)
- Any clinically significant abnormality identified at the time of screening that in the judgment of the investigator or any sub-investigator would preclude safe completion of the study or constrain assessment of endpoints, such as major systemic diseases or participants with short life expectancy.
- Participants considered by the investigator or any sub-investigator to be inappropriate for this study (e.g, geographic or social), actual or anticipated, that the investigator felt would restrict or limit the participant's participation for the duration of the study.
- Certain laboratory findings obtained during the screening period
The information listed above is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.
Data sourced from ClinicalTrials.gov (NCT01926782) and the linked publication. 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.