Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Enlicitide Decanoate, MK-0616
Enlicitide · 11 trials · 8 indications
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in LDL-C.
An AE is 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 is 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.
Blood samples will be collected at baseline and at Week 8 to assess mean percent change in LDL-C between participants treated with enlicitide and rosuvastatin versus placebo.
An AE is 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.
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.
Time to the first occurrence of CHD death-based MACE-plus, which is defined as any of the following: coronary heart disease death, myocardial infarction (MI), ischemic stroke (fatal and nonfatal), acute limb ischemia or major amputation, or urgent arterial revascularization (coronary, cerebrovascular, or peripheral).
An AE is 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 was defined as 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.
Blood samples will be collected to determine the Cmax of enlicitide.
Blood samples will be collected to determine the AUC0-24 of enlicitide.
Blood samples will be collected to determine the percent change from baseline in LDL-C.
An AE is 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 is 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.
Blood samples were collected at pre-specified time points to determine the AUC0-inf of enlicitide in plasma. AUC0-inf was defined as AUC0-last + (Cest,last/λz) where Cest, last was the estimated last measurable concentration, and λz was the apparent first-order terminal elimination rate constant.
Blood samples were collected at pre-specified time points to determine the Cmax of enlicitide in participant's plasma. Cmax was defined as the maximum observed concentration of enlicitide in plasma after the administration of a given dose.
AUC0-inf was a measure of the total amount of drug in the plasma from the dose administration extrapolated to infinity. Blood for plasma samples was collected at pre-specified timepoints to determine the AUC0-inf of enlicitide decanoate for Panel A, B, C, and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C ESRD - enlicitide decanoate pre-hemodialysis and Panel C ESRD - enlicitide decanoate post-hemodialysis to report AUC0-inf. Per protocol, mean AUC0-inf was reported.
AUClast was defined as the area under the concentration-time curve of enlicitide decanoate from time zero to last measurable concentration. Blood for plasma samples was collected at pre-specified timepoints to determine the AUClast of enlicitide decanoate in Panel A, B, C, and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C ESRD - enlicitide decanoate pre-hemodialysis and Panel C ESRD - enlicitide decanoate post-hemodialysis to report AUClast. Per protocol, mean AUClast was reported.
Cmax was defined as the maximum or peak concentration of enlicitide decanoate observed after its administration. Blood for plasma samples was collected at pre-specified time points to determine the Cmax of enlicitide decanoate in Panel A, B, C and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report Cmax. Per protocol, mean Cmax was reported.
Tmax was defined as the time required for a study drug to reach maximum concentration in plasma. Blood for plasma samples was collected at pre-specified time points to determine the Tmax of enlicitide decanoate in Panel A, B, C and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report Tmax. Per protocol, mean Tmax was reported.
Half-life (t1/2) was defined as the time required for plasma drug concentration of enclitide decanoate to decrease by 50% from peak. Blood for plasma samples was collected at pre-specified time points to determine the t1/2 of enlicitide decanoate in Panel A, B, C and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report t1/2. Per protocol, mean t1/2 was reported.
CL/F was the apparent total clearance of enlicitide decanoate in plasma over time. Blood for plasma samples was collected at pre-specified timepoints to determine the CL/F of enlicitide decanoate for Panel A, B, C, and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report CL/F. Per protocol, mean CL/F was reported.
Vz/F was the apparent volume of distribution of enlicitide decanoate between the plasma and the rest of the body, after dose, assessed as the total volume of enlicitide decanoate that would need to be uniformly distributed to achieve the desired plasma drug concentration. Blood for plasma samples was collected at pre-specified time points to determine the Vz/F of Enlicitide Decanoate in Panel A, B, C, and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report Vz/F. Per protocol, mean Vz/F was reported.
Blood samples will be collected to determine the AUC0-inf of MK-0616.
Blood samples will be collected to determine the AUC0-24 of MK-0616.
Blood samples will be collected to determine the AUC0-last of MK-0616.
Blood samples will be collected to determine the Cmax of MK-0616.
Blood samples will be collected to determine the C24 of MK-0616.
Blood samples will be collected to determine the apparent t1/2 of MK-0616.
Blood samples will be collected at pre-specified timepoints to determine the Tmax of MK-0616.
| Arm | Type | Description |
|---|---|---|
| Enlicitide Decanoate | EXPERIMENTAL | Participants will receive 20 mg enlicitide decanoate orally once daily (qd) for up to 24 weeks. |
| Placebo | OTHER | Participants will receive placebo orally qd for up to 24 weeks. |
| Enlicitide | EXPERIMENTAL | Participants will receive enlicitide and a rosuvastatin-matching placebo. Both will be delivered orally once daily (QD) for up to 12 weeks. |
| Enlicitide + Rosuvastatin | EXPERIMENTAL | Participants will receive enlicitide and rosuvastatin. Both will be delivered orally QD for up to 12 weeks. |
| Rosuvastatin | ACTIVE_COMPARATOR | Participants will receive rosuvastatin and an enlicitide-matching placebo. Both will be delivered orally QD for up to 12 weeks. |
| 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. |
| Blinded Portion: Enlicitide Decanoate | EXPERIMENTAL | Participants receive enlicitide decanoate 20 mg once daily. |
| Blinded Portion: Placebo | PLACEBO_COMPARATOR | Participants receive placebo once daily. |
| Open-Label Extension: Enlicitide Decanoate | EXPERIMENTAL | Participants who complete the blinded portion may enroll in this open-label extension arm. Participants in the extension arm receive enlicitide decanoate once daily up to 2 years. |
| Part A: Enlicitide Decanoate | EXPERIMENTAL | Participants receive enlicitide decanoate orally once daily (QD) at a dosage determined by age for up to 2 weeks. |
| Part B: Enlicitide Decanoate | EXPERIMENTAL | Participants receive enlicitide decanoate QD at a dosage determined by age for up to 24 weeks. |
| Part B: Placebo | PLACEBO_COMPARATOR | Participants receive placebo orally QD for up to 24 weeks. |
| Moderate Hepatic Impairment (HI) | EXPERIMENTAL | Participants will receive a single oral dose of enlicitide on Day 1 |
| Healthy Controls | EXPERIMENTAL | Participants will receive a single oral dose of enlicitide on Day 1 |
| Mild HI | EXPERIMENTAL | Participants will receive a single oral dose of enlicitide on Day 1 |
| Panel A: Moderate Renal Impairment (RI) | EXPERIMENTAL | Participants receive Enlicitide Decanoate 20 mg tablet single dose orally on Day 1 |
| Panel B: Severe RI | EXPERIMENTAL | Participants receive Enlicitide Decanoate 20 mg tablet single dose orally on Day 1 |
| Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD) | EXPERIMENTAL | Participants receive Enlicitide Decanoate 20 mg tablet orally on Day 1 and Day 16. |
| Panel D: Healthy Controls | EXPERIMENTAL | Participants receive Enlicitide Decanoate 20 mg tablet single dose orally on Day 1. |
| Sequence 1: MK-0616 Reference capsule→MK-0616 Formulation 1 (F1)→MK-0616 Formulation 2 (F2) | EXPERIMENTAL | Period 1: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. |
| Sequence 2: MK-0616 Reference capsule→MK-0616 F2→MK-0616 F1 | EXPERIMENTAL | Period 1: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. |
| Sequence 3: MK-0616 F1→MK-0616 Reference capsule→MK-0616 F2 | EXPERIMENTAL | Period 1: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. |
| Sequence 4: MK-0616 F1→MK-0616 F2→MK-0616 Reference capsule | EXPERIMENTAL | Period 1: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. |
| Sequence 5: MK-0616 F2→MK-0616 Reference capsule →MK-0616 F1 | EXPERIMENTAL | Period 1: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. |
| Sequence 6: MK-0616 F2→MK-0616 F1→MK-0616 Reference capsule | EXPERIMENTAL | Period 1: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. |
| Name | Type | Description |
|---|---|---|
| Enlicitide Decanoate | DRUG | Oral administration |
| Placebo | OTHER | Oral administration |
| Enlicitide | DRUG | Oral Tablet |
| Rosuvastatin | DRUG | Oral Capsule |
| Placebo for Enlicitide | DRUG | Oral Tablet |
| Placebo for Rosuvastatin | DRUG | Oral Capsule |
| Ezetimibe | DRUG | Oral tablet |
| Bempedoic Acid | DRUG | Oral capsule |
| Placebo for Ezetimibe | OTHER | ezetimibe-matching placebo oral tablet |
| Placebo for Bempedoic Acid | OTHER | bempedoic acid-matching placebo oral capsule |
| MK-0616 | DRUG | oral administration |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * History of a major atherosclerotic cardiovascular disease (ASCVD) event or if no history of a major ASCVD event, has one or more of the following: possible or definite diagnosis of heterozygous familial...
Enlicitide is an investigational oral small molecule being developed by Merck & Company, Inc. (MRK) for cardiovascular conditions. It is in Phase 3 clinical development for hypercholesterolemia, hyperlipidemia, heterozygous familial hypercholesterolemia (HeFH), arteriosclerosis, and hepatic insufficiency. It is also known as enlicitide decanoate.
Enlicitide is being studied to treat high cholesterol and related lipid disorders, including hypercholesterolemia, hyperlipidemia, and heterozygous familial hypercholesterolemia (HeFH). It is also being evaluated in people with arteriosclerosis and hepatic insufficiency. It is investigational and has not been approved for any indication.
Enlicitide is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is running the clinical development program for the drug across multiple Phase 1, Phase 2, and Phase 3 trials.
Enlicitide is in Phase 3 clinical development. The program includes four trials in total, with two currently active and three completed. The Phase 3 studies are evaluating the drug in adults with hyperlipidemia and hypercholesterolemia.
Enlicitide has been studied in trials including NCT07821944, a Phase 3 study in adults with hyperlipidemia in India; NCT07216482, a Phase 3 study in adults with high cholesterol across multiple countries; NCT07058077, a Phase 2 study in children and adolescents with HeFH; and NCT06575959, a completed Phase 1 study in people with liver function problems.
Yes, Enlicitide Decanoate is another name for Enlicitide. The two names refer to the same investigational drug, which is also identified by the development code MK-0616 in Merck's clinical program.