A Phase 2 interventional study of Alirocumab and Placebo Matched to Alirocumab in Hypercholesterolemia and Heterozygous Familial Hypercholesterolemia, sponsored by Regeneron Pharmaceuticals. Completed at 14 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-08-05.
Sponsored by Regeneron Pharmaceuticals · Phase 2, Interventional, and Treatment
The primary objective of the study was to assess the long-term safety and tolerability of alirocumab in patients with heFH who were receiving concomitant treatment with hydroxymethyl glutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins), with or without other lipid-modifying therapies (LMTs).
245 studies on the registry are indexed under Hyperlipoproteinemia Type II; 52 are open to participants now.
This study's enrollment of 58 is below the median of 86 across 170 interventional studies indexed under Hyperlipoproteinemia Type II.
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other exclusion criteria applied
Participants who received placebo in parent study (NCT01576484), has received a subcutaneous injection of placebo matched to alirocumab every 2 weeks for 4 years in this study.
Drug: Placebo Matched to Alirocumab
Participants who received alirocumab in parent study (NCT01576484), has received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
Drug: Alirocumab
Alirocumab was supplied in a pre-filled syringe and administered subcutaneously (SC) in the abdomen, thigh, or outer upper arm; REGN727(SAR236553) is an anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody
Also known as: REGN727, SAR236553, PRALUENT
Placebo matched to alirocumab was supplied in a pre-filled syringe and administered subcutaneously (SC) in the abdomen, thigh, or outer upper arm; REGN727(SAR236553) is an anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death
An AE was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. Treatment- emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on- treatment period (time from the first dose of study drug to the last dose of study drug plus 70 days). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Time frame: Baseline (Day 1 of current study) to end of study (Week 218)
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Week 24
Percent change for serum LDL-C (Low-density lipoprotein cholesterol) from baseline to Week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: Baseline (current study) to Week 24
Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in Current Study to Week 12
Percent change for serum LDL-C (Low-density lipoprotein cholesterol) from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: Baseline (current study) up to Week 12
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 24
Percent change for Apo B, Non-HDL-C and Total Cholesterol from baseline to Week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: Baseline(current study) up to Week 24
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol From Baseline in Current Study to Week 12
Percent change for serum Apo B, Non-HDL-C, and Total Cholesterol from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: Baseline (current study) up to Week 12
Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in Current Study to Week 52
Percent change for serum LDL-C from baseline to Week 52 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: Baseline (current study) up to Week 52
Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior Myocardial Infarction (MI)/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 24
Percentage of participants reaching LDL-C goal (ie, LDL-C \<70 mg/dL (1.81 millimoles per liter \[mmol/L\]) in case of prior MI/stroke, or \<100 mg/dL \[2.59 mmol/L\] for participants without prior MI/stroke) at week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, were reported.
Time frame: At Week 24
Percent Change in Lipoprotein a (Lp[a]) at Week 24
Percent change in serum lipoprotein a at week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.
Time frame: At Week 24
Percent Change in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and Week 12
Percent change for serum High Density Lipoprotein Cholesterol (HDL-C) in the current study at weeks 24 and week 12, during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.
Time frame: At Week 24 and 12
Percent Change in Lipoprotein a at Week 12
Percent change for serum Lipoprotein a at Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.
Time frame: At Week 12
Percent Change in Triglycerides (TG) at Week 24 and Week 12
Percent change for serum TG at Week 24 and Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.
Time frame: At Week 24 and 12
Percent Change in Apolipoprotein A-1 (Apo A-1) at Week 24 and Week 12
Percent change for serum Apo A-1 at Week 24 and Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.
Time frame: At Week 24 and Week 12
Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to the End of Treatment
Percent change for serum LDL-C from baseline to Week 208 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: Baseline (current study) to the End of Treatment (Week 208)
Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior MI/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 12, 52 and End of Treatment
Percentage of participants reaching LDL-C goal (ie, LDL-C \<70 mg/dL (1.81 millimoles per liter \[mmol/L\]) in case of prior MI/stroke, or \<100 mg/dL \[2.59 mmol/L\] for participants without prior MI/stroke) at week 12, 52 and end of treatment, during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, were reported.
Time frame: At Week 12, 52 and End of Treatment (Week 208)
Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Weeks 12, 24, 52, and End of Treatment
Absolute change was reported for serum LDL-C from baseline to weeks 12, 24, 52, and end of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: Baseline (current study) to Weeks 12, 24, 52, and End of Treatment (Week 208)
Percent Change in Apolipoprotein (Apo) B, Non-High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Lipoprotein a (Lp[a]), HDL-C, Triglycerides, and Apolipoprotein A-1 From Baseline in Current Study to Week 52 and End of Treatment
Percent change was reported for serum (Apo B), non-HDL-C, total-C, Lp(a), HDL-C, TG, and Apo A-1 from baseline to weeks 52 and end of treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: Baseline (current study) up to Weeks 52 and End of Treatment (Week 208)
Change in Ratio in Apolipoprotein (Apo) B/Apo A-1 From Baseline in Current Study to Week 12, 24, 52, and End of Treatment.
Change in ratio in Apolipoprotein (Apo) B/Apo A-1 from baseline in current Study to week 12, 24, 52, and end of treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: Baseline (current study) to Weeks 12, 24, 52, and End of Treatment (Week 208)
Percentage of Participants With Apolipoprotein (Apo) B <80 mg/dL at Week 12, 24, 52, and End of Treatment
Percentage of participants was calculated with Apo B \<80 mg/dL (0.8 mmol/L) at week 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: At Week 12, 24, 52, and End of Treatment (Week 208)
Percentage of Participants With Non-High Density Lipoprotein Cholesterol (HDL-C) <100 mg/dL (2.59 mmol/L) at Week 12, 24, 52, and End of Treatment
Percentage of participants was calculated with non-HDL-C \<100 mg/dL (2.59 mmol/L) at Weeks 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: At Week 12, 24, 52, and End of Treatment (Week 208)
Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) and/or ≥ 50% Reduction in LDL-C (if LDL-C >70 mg/dL [1.81 mmol/L]) at Week 12, 24, 52, and End of Treatment
Percentage of Participants was calculated with LDL-C \<70 mg/dL (1.81 mmol/L) and/or ≥ 50% Reduction in LDL-C (if LDL-C \>70 mg/dL \[1.81 mmol/L\]) at Weeks 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
Time frame: At Week 12, 24, 52, and End of Treatment (Week 208)
The study was conducted at 15 sites in the United States and Canada between 28 Feb 2012 and 22 Dec 2016. A total of 59 participants were screened in the study.
| Milestone | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study |
|---|---|---|
| Started | 12 | 46 |
| Completed | 7 | 27 |
| Not completed | 5 | 19 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Protocol violation | 0 | 2 |
| Withdrew: Sponsor decision | 2 | 8 |
| Withdrew: Withdrawal by subject | 0 | 3 |
| Withdrew: Other | 2 | 5 |
An AE was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. Treatment- emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on- treatment period (time from the first dose of study drug to the last dose of study drug plus 70 days). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
| Participants | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Adverse Events | 12 | 42 | 54 |
| Serious Adverse Events | 4 | 8 | 12 |
| Adverse Events Leading to Death | 0 | 0 | 0 |
Percent change for serum LDL-C (Low-density lipoprotein cholesterol) from baseline to Week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
| percent change | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to Week 24 | -73.15 ± 15.01 | -63.40 ± 22.04 | -65.35 ± 21.07 |
Percent change for serum LDL-C (Low-density lipoprotein cholesterol) from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
| percent change | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in Current Study to Week 12 | -55.93 ± 29.53 | -63.94 ± 23.35 | -62.22 ± 24.73 |
Percent change for Apo B, Non-HDL-C and Total Cholesterol from baseline to Week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
| percent change | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Apo B | -52.23 ± 20.30 | -50.52 ± 18.18 | -50.86 ± 18.43 |
| Non-HDL-C | -56.75 ± 21.80 | -55.43 ± 20.97 | -55.71 ± 20.95 |
| Total cholesterol | -42.72 ± 15.30 | -41.47 ± 16.37 | -41.74 ± 16.02 |
Percent change for serum Apo B, Non-HDL-C, and Total Cholesterol from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
| percent change | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Apo- B | -40.69 ± 30.46 | -48.78 ± 20.24 | -47.16 ± 22.56 |
| Non-HDL- C | -47.81 ± 32.92 | -54.97 ± 22.85 | -53.44 ± 25.18 |
| Total Cholesterol | -36.78 ± 24.88 | -40.47 ± 16.93 | -39.68 ± 18.72 |
Percent change for serum LDL-C from baseline to Week 52 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
| percent change | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in Current Study to Week 52 | -54.57 ± 26.20 | -55.67 ± 34.41 | -55.43 ± 32.53 |
Percentage of participants reaching LDL-C goal (ie, LDL-C \<70 mg/dL (1.81 millimoles per liter \[mmol/L\]) in case of prior MI/stroke, or \<100 mg/dL \[2.59 mmol/L\] for participants without prior MI/stroke) at week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, were reported.
| Percentage of Participants | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Percentage of Participants With Low Density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 Milligrams Per Deciliter (mg/dL) for Prior Myocardial Infarction (MI)/Stroke, or <100 mg/dL [2.59 mmol/L] for Participants Without Prior MI/Stroke at Week 24 | 100.00 | 90.91 | 92.73 |
Percent change in serum lipoprotein a at week 24 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.
| percent change | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Percent Change in Lipoprotein a (Lp[a]) at Week 24 | -27.91 ± 23.62 | -29.41 ± 25.01 | -29.11 ± 24.53 |
Percent change for serum High Density Lipoprotein Cholesterol (HDL-C) in the current study at weeks 24 and week 12, during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.
| percent change | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Week 24 | 2.61 ± 15.75 | 7.14 ± 16.04 | 6.17 ± 15.94 |
| Week 12 | 1.46 ± 14.08 | 10.43 ± 15.98 | 8.51 ± 15.91 |
Percent change for serum Lipoprotein a at Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.
| percent change | Placebo Matched to R727 | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Percent Change in Lipoprotein a at Week 12 | -20.30 ± 24.10 | -26.98 ± 22.71 | -25.64 ± 22.92 |
Percent change for serum TG at Week 24 and Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.
| percent change | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Week 24 | 0.19 ± 54.71 | -2.01 ± 41.22 | -1.54 ± 43.91 |
| Week 12 | -6.40 ± 46.11 | 0.52 ± 34.17 | -0.96 ± 36.69 |
Percent change for serum Apo A-1 at Week 24 and Week 12 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, was reported.
| percent change | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Week 24 | 5.41 ± 11.96 | 4.78 ± 11.20 | 4.91 ± 11.24 |
| Week 12 | 11.10 ± 11.43 | 8.64 ± 10.99 | 9.13 ± 11.02 |
Percent change for serum LDL-C from baseline to Week 208 during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
| percent change | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline in the Current Study to the End of Treatment | -52.20 ± 16.86 | -58.46 ± 23.51 | -57.36 ± 22.15 |
Percentage of participants reaching LDL-C goal (ie, LDL-C \<70 mg/dL (1.81 millimoles per liter \[mmol/L\]) in case of prior MI/stroke, or \<100 mg/dL \[2.59 mmol/L\] for participants without prior MI/stroke) at week 12, 52 and end of treatment, during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study, were reported.
| percentage of participants | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Week 12 | 83.33 | 90.91 | 89.29 |
| Week 52 | 75.00 | 83.33 | 81.48 |
| End of Treatment (Week 208) | 100 | 85.71 | 88.24 |
Absolute change was reported for serum LDL-C from baseline to weeks 12, 24, 52, and end of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
| Milligram per Deciliter (mg/dL) | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Week 12 | -92.0 ± 54.3 | -96.8 ± 44.7 | -95.8 ± 46.4 |
| Week 24 | -113.2 ± 24.9 | -95.3 ± 40.0 | -98.9 ± 37.9 |
| Week 52 | -87.0 ± 44.5 | -83.8 ± 58.6 | -84.5 ± 55.4 |
| Week 208 | -80.3 ± 38.7 | -78.1 ± 33.6 | -78.5 ± 33.2 |
Percent change was reported for serum (Apo B), non-HDL-C, total-C, Lp(a), HDL-C, TG, and Apo A-1 from baseline to weeks 52 and end of treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
| percent change | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Apo B : Week 52 | -43.04 ± 25.60 | -45.17 ± 28.51 | -44.73 ± 27.71 |
| Apo B : Week 208 | -45.02 ± 17.58 | -48.07 ± 18.61 | -47.53 ± 17.93 |
| Non- HDL-C: Week 52 | -47.10 ± 27.26 | -48.60 ± 31.71 | -48.27 ± 30.54 |
| Non- HDL-C: Week 208 | -43.29 ± 17.98 | -50.34 ± 21.40 | -49.10 ± 20.50 |
| Total -C : Week 52 | -35.09 ± 19.16 | -36.41 ± 24.89 | -36.11 ± 23.57 |
| Total -C : Week 208 | -35.33 ± 11.92 | -37.01 ± 16.59 | -36.72 ± 15.55 |
| Lp-(a): Week 52 | -24.77 ± 25.14 | -22.91 ± 30.33 | -23.30 ± 29.11 |
| Lp-(a): Week 208 | -23.92 ± 39.92 | -31.29 ± 30.20 | -29.99 ± 30.80 |
| HDL-C: Week 52 | 5.40 ± 17.64 | 7.74 ± 14.21 | 7.22 ± 14.89 |
| HDL-C: Week 208 | -9.83 ± 12.49 | 4.94 ± 11.25 | 2.34 ± 12.49 |
| TG : Week 52 | -6.04 ± 41.12 | -3.84 ± 40.25 | -4.33 ± 40.07 |
| TG : Week 208 | 16.69 ± 28.93 | -5.28 ± 23.05 | -1.40 ± 24.71 |
| Apo A-1 : Week 52 | 6.76 ± 10.82 | 3.90 ± 10.80 | 4.49 ± 10.76 |
| Apo A-1 : Week 208 | -1.46 ± 4.48 | 9.53 ± 7.45 | 7.59 ± 8.14 |
Change in ratio in Apolipoprotein (Apo) B/Apo A-1 from baseline in current Study to week 12, 24, 52, and end of treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
| Ratio | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Change at Week 12 | -0.397 ± 0.234 | -0.456 ± 0.230 | -0.444 ± 0.230 |
| Change at Week 24 | -0.450 ± 0.162 | -0.460 ± 0.211 | -0.458 ± 0.201 |
| Change at Week 52 | -0.385 ± 0.210 | -0.416 ± 0.295 | -0.410 ± 0.278 |
| Change at Week 208 | -0.330 ± 0.165 | -0.402 ± 0.164 | -0.389 ± 0.161 |
Percentage of participants was calculated with Apo B \<80 mg/dL (0.8 mmol/L) at week 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
| percentage of participants | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Week 12 | 66.67 | 79.55 | 76.79 |
| Week 24 | 91.67 | 81.82 | 83.93 |
| Week 52 | 66.67 | 73.81 | 72.22 |
| Week 208 | 100.00 | 85.71 | 88.24 |
Percentage of participants was calculated with non-HDL-C \<100 mg/dL (2.59 mmol/L) at Weeks 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
| percentage of participants | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Week 12 | 58.33 | 75.00 | 71.43 |
| Week 24 | 91.67 | 81.82 | 83.93 |
| Week 52 | 58.33 | 73.81 | 70.37 |
| Week 208 | 66.67 | 78.57 | 76.47 |
Percentage of Participants was calculated with LDL-C \<70 mg/dL (1.81 mmol/L) and/or ≥ 50% Reduction in LDL-C (if LDL-C \>70 mg/dL \[1.81 mmol/L\]) at Weeks 12, 24, 52, and End of Treatment (Week 208) during the efficacy treatment period, which is defined as the time from the first study drug injection up to 21 days after the last study drug injection in the current study.
| percentage of participants | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | All Participants |
|---|---|---|---|
| Week 12 | 66.67 | 86.36 | 82.14 |
| Week 24 | 100.00 | 81.82 | 85.45 |
| Week 52 | 75.00 | 73.81 | 74.07 |
| Week 208 | 66.67 | 85.71 | 82.35 |
Collected over All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Participants in Parent Study | 0/12 (0%) | 4/12 (33.3%) | 12/12 (100%) |
| Participants Previously Exposed to Alirocumab in Parent Study | 0/46 (0%) | 8/46 (17.4%) | 38/46 (82.6%) |
| Event | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study |
|---|---|---|
| Aortic valve stenosisCardiac disorders | 1/12 | 0/46 |
| Intestinal obstructionGastrointestinal disorders | 1/12 | 0/46 |
| AmnesiaNervous system disorders | 1/12 | 0/46 |
| Carotid artery diseaseNervous system disorders | 1/12 | 0/46 |
| Neuropsychiatric symptomsPsychiatric disorders | 1/12 | 0/46 |
| Angina unstableCardiac disorders | 0/12 | 1/46 |
| Atrial fibrillationCardiac disorders | 0/12 | 1/46 |
| Atrial flutterCardiac disorders | 0/12 | 1/46 |
| Coronary artery diseaseCardiac disorders | 0/12 | 1/46 |
| Colitis ischaemicGastrointestinal disorders | 0/12 | 1/46 |
| Event | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study |
|---|---|---|
| Injection site bruisingGeneral disorders | 5/12 | 6/46 |
| Upper respiratory tract infectionInfections and infestations | 4/12 | 13/46 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 3/12 | 8/46 |
| NasopharyngitisInfections and infestations | 2/12 | 11/46 |
| BronchitisInfections and infestations | 2/12 | 10/46 |
| HeadacheNervous system disorders | 1/12 | 10/46 |
| Back painMusculoskeletal and connective tissue disorders | 0/12 | 9/46 |
| MyalgiaMusculoskeletal and connective tissue disorders | 1/12 | 8/46 |
| DiarrhoeaGastrointestinal disorders | 2/12 | 6/46 |
| FatigueGeneral disorders | 2/12 | 3/46 |
The safety analysis set consisted of 58 patients (46 patients who previously received alirocumab and 12 patients who previously received placebo).
| Age, Continuous(Years) | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | Total |
|---|---|---|---|
| Mean | 54.9 ± 9.7 | 54.3 ± 9.4 | 54.4 ± 9.4 |
| Sex: Female, Male(Participants) | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | Total |
|---|---|---|---|
| Female | 6 | 14 | 20 |
| Male | 6 | 32 | 38 |
| Ethnicity (NIH/OMB)(Participants) | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 2 | 4 |
| Not Hispanic or Latino | 10 | 44 | 54 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo Participants in Parent Study | Participants Previously Exposed to Alirocumab in Parent Study | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 2 | 2 |
| White | 11 | 44 | 55 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Regeneron Pharmaceuticals