Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT02988115 CLEAR Serenity | Hypercholesterolemia | Percent Change From Baseline (PCFB) in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 Baseline; Week 12 | Bempedoic Acid | -22.58 percent change (±1.290 Standard Error) |
| Placebo | -1.17 percent change (±1.421 Standard Error) | |||
| NCT02991118 CLEAR Wisdom | Hypercholesterolemia | Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) Baseline; Week 12 | Bempedoic Acid | -15.07 percent change (±1.073 Standard Error) |
| Placebo | 2.35 percent change (±1.446 Standard Error) | |||
| NCT02993406 CLEAR Outcomes | Cardiovascular Diseases | Number of Participants With First Occurrence of Four Component Major Adverse Cardiovascular Events (MACE) Up to 68 months | Bempedoic Acid 180 mg | 819 Participants |
| Placebo Comparator | 927 Participants | |||
| NCT03001076 | Hypercholesterolemia | Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Week 12 | Bempedoic Acid | -23.46 percent change (±1.945 Standard Error) |
| Placebo | 4.99 percent change (±2.299 Standard Error) | |||
| NCT03067441 | Hypercholesterolemia | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Up to Week 82 | Bempedoic Acid; Bempedoic Acid | 403 Participants |
| Bempedoic Acid; Bempedoic Acid | 195 Participants | |||
| Bempedoic Acid; Bempedoic Acid | 160 Participants | |||
| Bempedoic Acid; Bempedoic Acid | 758 Participants | |||
| Bempedoic Acid; Bempedoic Acid | 202 Participants | |||
| OLE Bempedoic Acid | 288 Participants | |||
| OLE Bempedoic Acid | 241 Participants | |||
| OLE Bempedoic Acid | 1143 Participants | |||
| OLE Bempedoic Acid | 299 Participants | |||
| OLE Bempedoic Acid | 614 Participants | |||
| Placebo; Bempedoic Acid | 211 Participants | |||
| Placebo; Bempedoic Acid | 97 Participants | |||
| Placebo; Bempedoic Acid | 81 Participants | |||
| Placebo; Bempedoic Acid | 385 Participants | |||
| Placebo; Bempedoic Acid | 93 Participants | |||
| NCT03337308 | Hypercholesterolemia | Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) Baseline; Week 12 | Bempedoic Acid 180 mg | -17.2 Percent Change (±2.52 Standard Error) |
| Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | -36.2 Percent Change (±2.56 Standard Error) | |||
| Ezetimibe 10 mg | -23.2 Percent Change (±2.18 Standard Error) | |||
| Placebo | 1.8 Percent Change (±3.49 Standard Error) | |||
| NCT05683340 | — | Percent Change in LDL-C From Baseline to Week 12 Baseline, week12 | ETC-1002 180 mg | -25.25 Percent Change (±1.864 Standard Error) |
| Placebo | -3.46 Percent Change (±1.901 Standard Error) | |||
| NCT05687071 | — | Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs) From baseline to week 52 | ETC-1002 180 mg | 109 Participants |
| NCT05687071 | — | Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 Baseline, week52 | ETC-1002 180 mg | -21.55 Percent Change (±18.727 Standard Deviation) |
| NCT06450366 | Hypercholesterolemia | Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 56 Baseline and Day 56 | Bempedoic Acid | -6.3 Percent Change |
| Enlicitide | -64.6 Percent Change | |||
| Ezetimibe | -27.8 Percent Change | |||
| Ezetimibe + Bempedoic Acid | -36.5 Percent Change |