Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03531905 | Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C | PHASE2 | COMPLETED | 242 | — | — | May 9, 2018 | Jun 18, 2019 | Apr 9, 2020 | 4 | United States |
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...