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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06450366 | A Study to Evaluate the Efficacy and Safety of Enlicitide (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018/CORALreef AddOn) | PHASE3 | COMPLETED | 301 | — | — | Jul 8, 2024 | Mar 28, 2025 | Mar 27, 2026 | 35 | United States, Argentina +6 |
Blood samples were collected at baseline and after 56 days of treatment to assess mean percentage change in LDL-C. The mean percent change from baseline in LDL-C at Day-56 is reported.
| Arm | Type | Description |
|---|---|---|
| Enlicitide | EXPERIMENTAL | Participants receive enlicitide 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days. |
| Ezetimibe | ACTIVE_COMPARATOR | Participants receive ezetimibe 10mg, enlicitide-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days. |
| Bempedoic Acid | ACTIVE_COMPARATOR | Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide-matching placebo QD orally up to approximately 56 days. |
| Ezetimibe + Bempedoic Acid | ACTIVE_COMPARATOR | Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide-matching placebo orally QD for approximately 56 days. |
| Name | Type | Description |
|---|---|---|
| Enlicitide | DRUG | Oral tablet |
| Ezetimibe | DRUG | Oral tablet |
| Bempedoic Acid | DRUG | Oral capsule |
| Placebo for Enlicitide | OTHER | enlicitide-matching placebo oral tablet |
| Placebo for Ezetimibe | OTHER | ezetimibe-matching placebo oral tablet |
| Placebo for Bempedoic Acid | OTHER | bempedoic acid-matching placebo oral capsule |
Inclusion Criteria: * Has either a) history of a major atherosclerotic cardiovascular disease (ASCVD) event or b) if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event * Has fasted lipid values (evaluated by the central laboratory) at Visit...