Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ezetimibe · 1 trial · 1 indication
Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).
| Arm | Type | Description |
|---|---|---|
| Atorvastatin (statin rechallenge arm) | OTHER | Atorvastatin 20 mg over-encapsulated tablets orally once daily (QD) for 24 weeks and placebo (for alirocumab) subcutaneous (SC) injection every two weeks (Q2W) for 24 weeks added to stable lipid-modifying therapy (LMT). |
| Ezetimibe | ACTIVE_COMPARATOR | Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT. |
| Alirocumab 75 mg/ up to 150 mg | EXPERIMENTAL | Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk. |
| Name | Type | Description |
|---|---|---|
| Atorvastatin | DRUG | Atorvastatin over-encapsulated tablets. |
| Ezetimibe | DRUG | Ezetimibe over-encapsulated tablet. |
| Alirocumab | DRUG | Alirocumab SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm. |
| Placebo | DRUG | Placebo for alirocumab, ezitimibe and atorvastatin. |
Inclusion: 1. Patients with primary hypercholesterolemia \[Heterozygous Familial Hypercholesterolemia (heFH) or non-FH\] with moderate, high or very high CV risk and a history of statin intolerance 2. Provide signed informed consent Exclusion: 1. Calculated serum LDL-C \<70 mg/dL (1.81 mmol/L) an...
Ezetimibe is used for hypercholesterolemia, a condition of high cholesterol levels in the blood. It is being studied in patients with primary hypercholesterolemia who have moderate, high, or very high cardiovascular risk and are intolerant to statins. The drug is in Phase 3 clinical development for this indication.
Ezetimibe is a small molecule that targets cholesterol absorption in the intestine. By inhibiting the absorption of dietary and biliary cholesterol, it helps lower blood cholesterol levels. This mechanism is relevant for managing hypercholesterolemia, particularly in patients who cannot tolerate statins.
Ezetimibe is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol REGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with hypercholesterolemia.
Ezetimibe is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial is designed to assess its effects in patients with primary hypercholesterolemia who are intolerant to statins.
Ezetimibe is being evaluated in a Phase 3 clinical trial with the identifier NCT01709513. This study, titled 'Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)', enrolled 314 participants and has been completed.
Ezetimibe is not the same as Alirocumab. The clinical trial NCT01709513 is studying Alirocumab, which is a different drug, in patients with hypercholesterolemia. Ezetimibe is a separate investigational drug being developed by Regeneron Pharmaceuticals for the same condition.