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Bempedoic Acid+ Ezetimibe Fixed-Dose Combination · 1 trial · 1 indication
Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the mean of the LDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline in LDL-C was analyzed using analysis of covariance (ANCOVA) with treatment group and randomization stratification as a factors and baseline LDL-C as a covariate. Percent change from baseline was calculated as: (\[LDL-C value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100. For LDL-C, if measured LDL-C value was available, measured LDL-C was used.
| Arm | Type | Description |
|---|---|---|
| BA 180 mg + EZE 10 mg FDC | EXPERIMENTAL | Bempedoic acid (BA) + ezetimibe (EZE) fixed-dose combination (FDC) 180 mg/10 mg tablets taken orally once daily for 12 weeks |
| BA 180 mg | EXPERIMENTAL | Bempedoic acid (BA) 180 mg tablets taken orally once daily for 12 weeks |
| EZE 10 mg | ACTIVE_COMPARATOR | Ezetimibe (EZE) 10 mg overencapsulated tablets taken orally once daily for 12 weeks |
| Placebos | PLACEBO_COMPARATOR | Placebos to match identical bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or identical bempedoic acid 180 mg tablet, or identical ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Bempedoic Acid + Ezetimibe Fixed-Dose Combination | COMBINATION_PRODUCT | bempedoic acid + ezetimibe FDC 180 mg/10 mg tablet |
| Bempedoic Acid | DRUG | bempedoic acid 180 mg tablet |
| Ezetimibe | DRUG | ezetimibe 10 mg overencapsulated tablet |
| Placebos | DRUG | placebo tablet or capsule to match bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or bempedoic acid 180 mg tablet, or ezetimibe 10 mg capsule |
Inclusion Criteria: * Require lipid-modifying therapy for primary or secondary prevention of cardiovascular disease * Fasting LDL-C ≥ 130 mg/dL for primary prevention or LDL-C ≥ 100 mg/dL for secondary prevention (history of HeFH and/or ASCVD) * Treated with maximally tolerated statin therapy at st...
Bempedoic Acid + Ezetimibe Fixed-Dose Combination is an investigational small molecule being developed for cardiovascular diseases, diabetes, hypercholesterolemia, and hyperlipidemias. It is a fixed-dose combination of bempedoic acid and ezetimibe, intended to lower elevated LDL cholesterol in patients with these lipid disorders.
Bempedoic Acid + Ezetimibe Fixed-Dose Combination is being developed by Esperion Therapeutics, Inc. (NASDAQ: ESPR). The company is conducting clinical trials to evaluate the safety and efficacy of this fixed-dose combination for treating lipid disorders.
Bempedoic Acid + Ezetimibe Fixed-Dose Combination is in Phase 3 clinical development. It remains investigational and has not been approved by the FDA. Seven clinical trials have been completed, including Phase 2 and Phase 3 studies, with no active trials currently ongoing.
Bempedoic Acid + Ezetimibe Fixed-Dose Combination has been studied in seven completed trials. Key studies include NCT03337308, a Phase 3 trial comparing the combination to bempedoic acid, ezetimibe, and placebo in patients on maximally tolerated statin therapy, and NCT03051100, a Phase 2 triplet therapy study with atorvastatin.
Bempedoic Acid + Ezetimibe Fixed-Dose Combination is a distinct product that combines two active ingredients: bempedoic acid and ezetimibe. It is not the same as bempedoic acid monotherapy. Clinical trials have evaluated the combination against bempedoic acid alone to assess its added efficacy.