Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Enlicitide Decanoate · 12 trials · 6 indications
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.
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).
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in LDL-C.
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.
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 will be collected to determine the AUC0-48hr of Levothyroxine (T4).
Blood samples will be collected to determine the Cmax of Levothyroxine (T4).
Blood samples will be collected to determine the Tmax of Levothyroxine (T4).
Blood samples will be collected to determine the AUC0-48hr of triiodothyronine (T3).
Blood samples will be collected to determine the Cmax of triiodothyronine (T3).
Blood samples will be collected to determine the Tmax of triiodothyronine (T3).
Blood samples will be collected to determine the AUC0-Inf of warfarin.
Blood samples will be collected to determine the AUC0-Last of warfarin.
Blood samples will be collected to determine the Cmax of warfarin.
Blood samples will be collected to determine the Tmax of warfarin.
Blood samples will be collected to determine the t½ of warfarin.
Blood samples will be collected to determine the CL/F of warfarin.
Blood samples will be collected to determine the Vz/F of warfarin.
Blood samples will be collected to determine the AUC0-Inf of lisinopril.
Blood samples will be collected to determine the AUC0-Last of lisinopril.
Blood samples will be collected to determine the Cmax of lisinopril.
Blood samples will be collected to determine the Tmax of lisinopril.
Blood samples will be collected to determine the t½ of lisinopril.
Blood samples will be collected to determine the CL/F of lisinopril.
Blood samples will be collected to determine the Vz/F of lisinopril.
Blood samples will be collected to determine the AUC0-24 of enlicitide decanoate.
Blood samples will be collected to determine the AUC0-last of enlicitide decanoate.
Blood samples will be collected to determine the AUC0-inf of enlicitide decanoate.
Blood samples will be collected to determine the Cmax of enlicitide decanoate.
Blood samples will be collected to determine the Tmax of enlicitide decanoate.
Blood samples will be collected to determine the t1/2 of enlicitide decanoate.
Blood samples will be collected to determine the CL/F of enlicitide decanoate.
Blood samples will be collected to determine the Vz/F of enlicitide decanoate.
Blood samples will be collected to determine the AUC0-24hrs of enlicitide decanoate.
Blood samples will be collected to determine the AUC0-24hrs of semaglutide.
Blood samples will be collected to determine the Cmax of semaglutide.
Blood samples will be collected to determine the Tmax of semaglutide.
Blood samples will be collected to determine the AUC0-Inf of atorvastatin and its metabolites.
Blood samples will be collected to determine the AUC0-Last of atorvastatin and its metabolites.
Blood samples will be collected to determine the Cmax of atorvastatin and its metabolites.
Blood samples will be collected to determine the Tmax of atorvastatin and its metabolites.
Blood samples will be collected to determine the t1/2 of atorvastatin and its metabolites.
Blood samples will be collected to determine the CL/F of atorvastatin.
Blood samples will be collected to determine the Vz/F of atorvastatin.
Blood samples will be collected to determine the AUC0-Inf of enlicitide decanoate.
Blood samples will be collected to determine the AUC0-Last of enlicitide decanoate.
Blood samples will be collected to determine the Vz/F of enlicitide decanoate.
Tlag is the time from dosing to the first appearance in plasma. Blood samples will be collected to determine the tlag of enlicitide decanoate.
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.
| Arm | Type | Description |
|---|---|---|
| Enlicitide Decanoate | EXPERIMENTAL | Participants will receive 20 mg of enlicitide decanoate orally once daily (QD) |
| 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. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive enlicitide decanoate-matching placebo orally QD for up to 52 weeks. |
| 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. |
| Levothyroxine | EXPERIMENTAL | Participants will receive a single oral dose of levothyroxine. |
| Levothyroxine Plus Enlicitide Decanoate | EXPERIMENTAL | Participants will receive a single oral dose of levothyroxine and a single oral dose of enlicitide decanoate at the same time. |
| Warfarin Plus Enlicitide Decanoate | EXPERIMENTAL | Participants receive oral warfarin and oral enlicitide decanoate. |
| Lisinopril Plus Enlicitide Decanoate | EXPERIMENTAL | Participants receive oral lisinopril and oral enlicitide decanoate. |
| Enlicitide Decanoate Treatment A | EXPERIMENTAL | Participants will receive a single dose of enlicitide decanoate formulation 1 on Day 1 on an empty stomach. |
| Enlicitide Decanoate Treatment B | EXPERIMENTAL | Participants will receive a single dose of enlicitide decanoate formulation 2 on Day 1 on an empty stomach. |
| Enlicitide Decanoate and Semaglutide | EXPERIMENTAL | Period 1: Participants receive an oral dose of enlicitide decanoate every day for 1 week. Period 2: Participants receive an oral dose of semaglutide every day for 6 weeks. Period 3: Participants receive an oral dose of both enlicitide decanoate and semaglutide every day for 1 week. |
| Atorvastatin | EXPERIMENTAL | Participants receive a single oral dose of atorvastatin (Treatment A) on Day 1. |
| Enlicitide Decanoate + Atorvastatin | EXPERIMENTAL | Participants receive a single oral dose of enlicitide decanoate plus a single oral dose of atorvastatin (Treatment B) on Day 1. |
| Enlicitide Decanoate Food Effect | EXPERIMENTAL | Participants will be administered enlicitide decanoate on Day 1 with or without food. |
| Enlicitide Decanoate Water Effect | EXPERIMENTAL | Participants will be administered enlicitide decanoate on Day 1 with high, medium, and low volumes of water. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Enlicitide Decanoate | DRUG | Oral tablet |
| Placebo | DRUG | Placebo tablet matched to enlicitide decanoate taken by mouth. |
| Levothyroxine | DRUG | single oral dose |
| Warfarin | DRUG | single oral dose |
| Lisinopril | DRUG | single oral dose |
| Semaglutide | DRUG | multiple doses, oral tablet |
| Atorvastatin | DRUG | Oral administration |
Inclusion Criteria: * Has completed an enlicitide decanoate (also known as enlictide and MK-0616) parent study \[MK-0616-013 (NCT05952856), MK-0616-017 (NCT05952869), and MK-0616-018 (NCT06450366)\] per protocol (including the final assessments/procedures of their parent study) * Had an overall stu...
Enlicitide Decanoate is an investigational small molecule being developed for cardiovascular conditions including arteriosclerosis, heterozygous familial hypercholesterolemia (HeFH), and hypercholesterolemia. It is currently in Phase 3 clinical development by Merck & Company, Inc. (MRK). The drug is being studied to address cholesterol-related disorders.
Enlicitide Decanoate is a small molecule with a peptide-based target class, classified as a -tide (peptide) therapeutic. It is being developed to target pathways involved in cholesterol metabolism for the treatment of hypercholesterolemia and related cardiovascular conditions. The specific molecular target has not been disclosed in available information.
Enlicitide Decanoate is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical trials to evaluate the drug for cardiovascular indications including hypercholesterolemia and heterozygous familial hypercholesterolemia.
Enlicitide Decanoate is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 program includes studies in patients with hypercholesterolemia and related conditions, building on earlier Phase 1 trials in healthy volunteers.
Enlicitide Decanoate has been studied in several clinical trials. Phase 1 trials include NCT06625814, NCT06691906, NCT06699329, and NCT06699355, all completed in healthy adults in the United States. These studies evaluated the drug alone and in combination with levothyroxine, semaglutide, and atorvastatin. The drug is now in Phase 3 development.
Yes, Enlicitide Decanoate is also known as MK-0616. Clinical trial records reference both names, with studies titled using MK-0616 as the identifier. This includes Phase 1 trials in healthy participants and the ongoing Phase 3 program for cardiovascular indications.