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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05261126 | A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008) | PHASE2 | COMPLETED | 381 | — | — | Mar 10, 2022 | Nov 28, 2022 | Dec 9, 2024 | 63 | United States, Germany +6 |
Blood samples were collected at baseline and after 8 weeks of treatment to assess mean percent change in LDL-C. Based on a constrained longitudinal analysis (cLDA) model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. The percent change from baseline in LDL-C at week 8 was reported.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced at least one AE was reported.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to AEs was reported.
| Arm | Type | Description |
|---|---|---|
| Enclitide Chloride 6 mg | EXPERIMENTAL | Participants will receive 6 mg of enlicitide chloride orally QD for 8 weeks |
| Enclitide Chloride 12 mg | EXPERIMENTAL | Participants will receive 12 mg of enlicitide chloride orally QD for 8 weeks |
| Enclitide Chloride 18 mg | EXPERIMENTAL | Participants will receive 18 mg of enlicitide chloride orally QD for 8 weeks |
| Enclitide Chloride 30 mg | EXPERIMENTAL | Participants will receive 30 mg of enlicitide chloride orally QD for 8 weeks |
| Placebo | PLACEBO_COMPARATOR | Participants will receive enlicitide chloride-matching placebo orally QD for 8 weeks |
| Name | Type | Description |
|---|---|---|
| Enclitide Chloride | DRUG | Enclitide Chloride administered orally |
| Placebo | DRUG | Placebo matching enclitide chloride administered orally |
Inclusion Criteria: * History of clinical atherosclerotic cardiovascular disease (ASCVD), or has an ASCVD risk equivalent and/or a 10-year risk of having an ASCVD event ≥5.0%, AND has a corresponding LDL-C that falls within the protocol-specified range at screening. * Treatment with a stable dose o...