Phase 3
Completed N=163
Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin
Source: ClinicalTrials.gov NCT02584504 ↗Enrolled (actual)
163
Serious AEs
5.0%
Results posted
May 2018
Primary outcomePrimary: Percent Change From Baseline in Calculated LDL-C at Week 12- Intent to Treat (ITT) Analysis — -43.8; -70.1; -4.3 percent change — p=<0.0001
◆ Published Evidence
Established
22citations · ~3 / year
Efficacy and safety of alirocumab 150mg every 4 weeks in hypercholesterolemic patients on non-statin lipid-lowering therapy or lowest strength dose of statin: ODYSSEY NIPPON.
Summary
Primary Objective:
To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab administration as add-on therapy to non-statin lipid modifying therapy (LMT) including diet therapy alone or the lowest strength of statin in comparison with placebo after 12 weeks of treatment in participants with hypercholesterolemia.
Secondary Objective:
* To evaluate the effect of two treatment regimens of alirocumab on other lipid parameters: apolipoprotein B (Apo-B), non-high-density lipoprotein cholesterol (non HDL-C), total cholesterol (TC), lipoprotein (a) (Lp[a]), high-density lipoprotein cholesterol (HDL-C), triglyceride (TG), and apolipoprotein A-1 (Apo A-1).
* To evaluate the safety and tolerability of alirocumab administration.
* To evaluate the development of anti-alirocumab antibodies.
* To evaluate the pharmacokinetic and pharmacodynamic profiles of alirocumab administration.
* To evaluate the long-term safety in participants receiving open-label alirocumab administration.
Linked Publications (2)
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Efficacy and safety of alirocumab 150mg every 4 weeks in hypercholesterolemic patients on non-statin lipid-lowering therapy or lowest strength dose of statin: ODYSSEY NIPPON.
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Efficacy and safety of alirocumab in patients with hypercholesterolemia not adequately controlled with non-statin lipid-lowering therapy or the lowest strength of statin: ODYSSEY NIPPON study design and rationale.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Calculated LDL-C at Week 12- Intent to Treat (ITT) Analysis |
-43.8; -70.1; -4.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 12- On-Treatment Analysis |
-43.4; -70.1; -2.8 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C to Averaged Week 10 to 12: ITT Analysis |
-54.2; -69.9; -3.7 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C to Averaged Week 10 to 12- On-Treatment Analysis |
-54.0; -69.9; -2.6 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 12: ITT Analysis |
-32.2; -57.9; -6.0 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo-B at Week 12- On-Treatment Analysis |
-31.8; -58.0; -4.6 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12: ITT Analysis |
-36.2; -61.1; -4.9 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 12- On-treatment Analysis |
-35.9; -61.1; -3.5 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12- ITT Analysis |
-25.8; -44.7; -3.3 | <0.0001 sig |
| SECONDARY Percentage of Participants Reaching Calculated LDL-C Goal at Week 12- ITT Analysis |
85.2; 96.2; 14.3 | <0.0001 sig |
| SECONDARY Percentage of Participants Reaching Calculated LDL-C Goal at Week 12- On-Treatment Analysis |
85.2; 96.2; 10.8 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein (a) at Week 12: ITT Analysis |
-31.7; -49.6; 1.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12- ITT Analysis |
7.7; 9.9; 2.0 | 0.0241 sig |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides (TGs) at Week 12: ITT Analysis |
-0.6; -18.0; -6.4 | 0.2645 |
| SECONDARY Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 12: ITT Analysis |
6.8; 9.1; 2.9 | — |
Eligibility Criteria
Inclusion criteria
Participants with hypercholesterolemia (heFH or non-FH) receiving non statin LMTs or the lowest strength of statin.
Exclusion criteria
- LDL-C 400 mg/dL (>4.52 mmol/L) at the screening period.
- Systolic blood pressure (BP) >160 mmHg or diastolic BP >100 mmHg at the run-in visit (Week -7) or the screening visit (Week -3) or the randomization visit (Week 0).
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 (NCT02584504) 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.