Phase 3
Completed N=986
Open Label Study of Long Term Safety Evaluation of Alirocumab
Source: ClinicalTrials.gov NCT01954394 ↗Enrolled (actual)
986
Serious AEs
21.5%
Results posted
Jul 2018
Primary outcomePrimary: Percentage of Participants Who Experienced Adverse Events (AEs) — 83.9; 87.3; 86.2; 20.6 percentage of participants
◆ Published Evidence
Established
58citations · ~7 / year
Long-term safety and efficacy of alirocumab in patients with heterozygous familial hypercholesterolemia: An open-label extension of the ODYSSEY program.
Summary
Primary Objective:
To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831).
Secondary Objectives:
* To evaluate the long-term efficacy of alirocumab on lipid parameters.
* To evaluate the long-term immunogenicity of alirocumab.
Linked Publications (3)
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Long-term safety and efficacy of alirocumab in patients with heterozygous familial hypercholesterolemia: An open-label extension of the ODYSSEY program.
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Individualized low-density lipoprotein cholesterol reduction with alirocumab titration strategy in heterozygous familial hypercholesterolemia: Results from an open-label extension of the ODYSSEY LONG TERM trial.
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Alirocumab dosing patterns during 40 months of open-label treatment in patients with heterozygous familial hypercholesterolemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced Adverse Events (AEs) |
83.9; 87.3; 86.2; 20.6; 22.0; 21.5 | — |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 |
-44.9; -43.8; -44.2; -46.9; -46.9; -46.9 | — |
| SECONDARY Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 |
-66.8; -67.1; -67.0; -70.3; -72.7; -71.9 | — |
| SECONDARY Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 |
-1.729; -1.738; -1.735; -1.821; -1.883; -1.863 | — |
| SECONDARY Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time |
12.1; 11.5; 11.7; 71.0; 86.1; 81.1 | — |
| SECONDARY Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time |
0.9; 1.2; 1.1; 47.4; 66.4; 60.1 | — |
| SECONDARY Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time |
0.9; 1.2; 1.1; 49.5; 67.1; 61.3 | — |
| SECONDARY Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 |
-38.1; -37.6; -37.8; -40.6; -40.4; -40.5 | — |
| SECONDARY Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 |
-27.9; -27.7; -27.7; -30.1; -30.2; -30.1 | — |
| SECONDARY Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 |
5.6; 6.6; 6.3; 5.7; 5.8; 5.8 | — |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 |
3.4; 3.5; 3.5; 0.6; 1.0; 0.9 | — |
| SECONDARY Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168 |
-15.0; -26.4; -22.6; -13.9; -21.4; -18.9 | — |
| SECONDARY Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168 |
-36.9; -37.8; -37.5; -36.9; -38.0; -37.6 | — |
| SECONDARY Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168 |
5.6; 5.8; 5.7; 7.8; 8.5; 8.3 | — |
| SECONDARY Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168 |
-0.340; -0.361; -0.354; -0.340; -0.375; -0.363 | — |
Eligibility Criteria
Inclusion criteria
Participants with heFH who had completed one of the four parent studies (EFC12492, R727-CL-1112, EFC12732 and LTS11717).
Exclusion criteria
Significant protocol deviation in the parent study; Any permanent treatment discontinuation from the parent study.
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 (NCT01954394) 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.