Phase 3
Completed N=1,561
Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
ASCVD · Elevated Cholesterol
Source: ClinicalTrials.gov NCT03399370 ↗
Enrolled (actual)
1,561
Serious AEs
24.4%
Results posted
Oct 2020
Primary outcomePrimary: Percentage Change in LDL-C From Baseline to Day 510 — -56.34; 1.30 percent change — p=<.0001
◆ Published Evidence
Highly cited
1,565citations · ~261 / year
Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol.
Summary
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be a multicenter study in the United States.
Linked Publications (3)
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Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol.
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A systematic review and meta-analysis of tolerability, cardiac safety and efficacy of inclisiran for the therapy of hyperlipidemic patients.
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Plain language summary of results from ORION-10 and ORION-11: two studies to learn how well inclisiran works in people with high cholesterol.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in LDL-C From Baseline to Day 510 |
-56.34; 1.30 | <.0001 sig |
| PRIMARY Time-adjusted Percentage Change in LDL-C Levels From Baseline After Day 90 and up to Day 540 |
-51.27; 2.51 | <0.0001 sig |
| SECONDARY Absolute Change in LDL-C From Baseline to Day 510 |
-56.18; -2.06 | <0.0001 sig |
| SECONDARY Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540 |
-53.66; -0.39 | <0.0001 sig |
| SECONDARY Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510 |
-69.78; 13.52 | <0.0001 sig |
| SECONDARY Percentage Change in Total Cholesterol From Baseline to Day 510 |
-33.56; -0.42 | <0.0001 sig |
| SECONDARY Percentage Change in Apolipoprotein B (ApoB) From Baseline to Day 510 |
-44.81; -1.72 | <.0001 sig |
| SECONDARY Percentage Change in Non-HDL-C From Baseline to Day 510 |
-47.41; -0.05 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Male or female participants ≥18 years of age.
- History of ASCVD (coronary heart disease [CHD], cardiovascular disease [CVD], or peripheral arterial disease [PAD]).
- Serum LDL-C ≥1.8 millimole (mmol)/liter (L) (≥70 mg/dL).
- Fasting triglyceride 2 years postmenopausal (defined as 1 year or longer since last menstrual period) and more than 55 years of age.
- Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.
- Women who are surgically sterilized at least 3 months prior to enrollment.
- Males who are unwilling to use an acceptable method of birth control during the entire study period (such as condom with spermicide).
- Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer.
- Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT03399370) 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.