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Bempedoic acid+ Ezetimibe · 1 trial · 3 indications
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the average of LDL-C values at the Screening Visit 3 (Visit S3) and the Treatment Visit 1 (Visit T1) (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for LDL-C was analyzed using analysis of covariance (ANCOVA), with treatment as factor and Baseline lipid parameter as a covariate. Missing data for LDL-C was imputed using the last observation carried forward (LOCF) method. 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 a measured LDL-C value was available, measured LDL-C was used.
| Arm | Type | Description |
|---|---|---|
| Bempedoic acid + Ezetimibe FDC | EXPERIMENTAL | Bempedoic acid + Ezetimibe FDC Oral Tablet; Placebo oral capsule |
| Ezetimibe 10 mg | ACTIVE_COMPARATOR | Ezetimibe 10Mg Oral Tablet; Placebo Oral Tablet |
| Placebo | PLACEBO_COMPARATOR | Placebo Oral Tablet, Placebo oral capsule |
| Name | Type | Description |
|---|---|---|
| Bempedoic acid + Ezetimibe FDC Oral Tablet | DRUG | Experimental therapy of bempedoic acid 180 mg + ezetimibe 10 mg FDC tablet |
| Ezetimibe 10 mg Oral Tablet | DRUG | Ezetimibe 10 mg tablet, overencapsulated for blinding purposes |
| Placebo Oral Tablet | DRUG | Placebo tablet, matched for the FDC product for blinding purposes |
| Placebo oral capsule | DRUG | Placebo over-encapsulated for blinding purposes |
Inclusion Criteria: * Type 2 diabetes for 6 months or greater * Currently taking stable diabetes medication for 3 months or greater * HbA1c between 7-10% * LDL-cholesterol greater than 70 mg/dL * Women must not be pregnant, lactating, or planning to become pregnant within 30 days after last dose of...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| FibroBiologics, Inc. | FBLG | 1 | PHASE1 | Undisclosed |
| MiMedx Group, Inc. | MDXG | 2 | N/A | Undisclosed |
| Integra LifeSciences Holdings Corporation | IART | 1 | N/A | Undisclosed |
| Organogenesis Holdings, Inc. Class A | ORGO | 1 | N/A | Undisclosed |
| Healthcare Services Group, Inc. | HCSG | 1 | N/A | Undisclosed |
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.