Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Enlicitide · 11 trials · 6 indications
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.
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.
Blood samples will be collected to determine the AUC0-inf of enlicitide.
Blood samples will be collected to determine the Cmax of enlicitide.
Blood samples will be collected to determine the AUC0-Last of enlicitide.
Blood samples will be collected to determine the AUC0-Inf of enlicitide.
Blood samples will be collected to estimate Cmax of enlicitide.
Blood samples will be collected to determine the AUC0-inf of enlicitide when administered with coffee
Blood samples will be collected to determine the AUC from time 0 to the time of last quantifiable sample of enlicitide when administered with coffee
Blood samples will be collected to determine the maximum observed drug concentration of enlicitide when administered with coffee
Blood samples will be collected to determine the AUC from time 0 to the time of last quantifiable sample of enlicitide when administered with tea
Blood samples will be collected to determine the AUC0-inf of enlicitide when administered with tea.
Blood samples will be collected to determine the maximum observed drug concentration of enlicitide when administered with tea
Blood samples will be collected to determine the AUC0-24hr of enlicitide.
Blood samples will be collected to determine the AUC0-Last of enlicitide.
Blood samples will be collected to determine the AUC0-Inf of enlicitide.
Blood samples will be collected to determine the Cmax of enlicitide.
Blood samples will be collected to determine the AUC0-inf of lithium in plasma.
Blood samples will be collected to determine the AUC0-last of lithium in plasma.
Blood samples will be collected determine the Cmax of lithium in plasma.
AUC0-24 of enlicitide in plasma will be determined.
Tmax of enlicitide in plasma will be determined.
CL/F of enlicitide in plasma will be determined.
Vz/F of enlicitide in plasma will be determined.
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.
AUC0-inf of enlicitide in plasma will be determined.
AUC0-last of enlicitide in plasma will be determined.
t1/2 of enlicitide in plasma will be determined.
tlag is the time from dosing to the first appearance in plasma. The tlag of enlicitide in plasma will be determined.
AUC0-inf is the area under the plasma concentration versus time curve (AUC) for digoxin, from time zero (pre-dose) to extrapolated infinite time.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive an enlicitide-matching placebo and a rosuvastatin-matching placebo. Placebos 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. |
| Treatment A: Enlicitide Reference | EXPERIMENTAL | Participants will receive a single oral dose of enlicitide reference formulation. |
| Treatment B: Enlicitide Formulation Test 1 - Fed | EXPERIMENTAL | Participants will receive a single oral dose of enlicitide formulation test 1 after a high-fat breakfast. |
| Treatment C: Enlicitide Formulation Test 1 - Fasted | EXPERIMENTAL | Participants will receive a single oral dose of enlicitide formulation test 1 under fasted conditions. |
| Treatment D: Enlicitide Formulation Test 2 - Fed | EXPERIMENTAL | Participants will receive a single oral dose of enlicitide formulation test 2 after a high-fat breakfast. |
| Treatment E: Enlicitide Formulation Test 2 - Fasted | EXPERIMENTAL | Participant will receive a single oral dose of enlicitide formulation test 2 under fasted conditions. |
| Dose regimen A | EXPERIMENTAL | Participants receive enlicitide orally at dose regimen A. |
| Dose regimen B | EXPERIMENTAL | Participants receive enlicitide orally at dose regimen B. |
| Dose regimen C | ACTIVE_COMPARATOR | Participants receive enlicitide orally at dose regimen C. |
| Enlicitide Coffee Sequence 1 | EXPERIMENTAL | Participants will be randomized to receive enlicitide administered with water in period 1 and enlicitide with coffee in period 2. |
| Enlicitide Coffee Sequence 2 | EXPERIMENTAL | Participants will be randomized to receive enlicitide administered with coffee in period 1 and enlicitide with water in period 2. |
| Enlicitide Tea Sequence 1 | EXPERIMENTAL | Participants will be randomized to receive enlicitide administered with water in period 1 and enlicitide with tea in period 2. |
| Enlicitide Tea Sequence 2 | EXPERIMENTAL | Participants will be randomized to receive enlicitide administered with tea in period 1 and enlicitide with water in period 2. |
| Treatment A: enlicitide reference tablet | EXPERIMENTAL | Participants receive a single oral dose of enlicitide reference tablet. |
| Treatment B: enlicitide test tablet | EXPERIMENTAL | Participants receive a single oral dose of enlicitide test tablet. |
| Lithium Carbonate | EXPERIMENTAL | On Day 1 of Period 1, a single oral dose of lithium carbonate will be administered. |
| Enlicitide with Lithium Carbonate | EXPERIMENTAL | On Day 1 of Period 2, a single oral dose of lithium carbonate will be coadministered with a single oral dose of enlicitide. |
| Panel A: Severe Renal Impairment | EXPERIMENTAL | Participants with severe renal impairment receive enlicitide once daily (QD) for 28 days. |
| Panel B: Healthy | EXPERIMENTAL | Healthy participants receive enlicitide QD for 28 days. |
| Enlicitide Treatment A | EXPERIMENTAL | Participants receive single oral dose of enlicitide after 8-hour overnight fast. |
| Enlicitide Treatment B | EXPERIMENTAL | Participants receive single oral dose of enlicitide 4 hours after morning meal. |
| Enlicitide Treatment C | EXPERIMENTAL | Participants receive single oral dose of enlicitide 3 hours after morning meal. |
| Enlicitide Treatment D | EXPERIMENTAL | Participants receive single oral dose of enlicitide 2 hours after morning meal. |
| Sequence 1: 0.25mg Digoxin-->0.25mg Digoxin plus 20mg enlicitide/180mg Sodium Caprate | EXPERIMENTAL | Participants will receive 1 tablet of 0.25mg Digoxin on Day 1 of period 1 and 1 tablet of 0.25mg Digoxin coadministered with 1 tablet of 20 mg enlicitide/180 mg sodium caprate on Day 1 of Period 2. |
| Sequence 2: 0.25mg Digoxin plus 20mg enlicitide/180mg Sodium Caprate-->0.25mg Digoxin | EXPERIMENTAL | Participants will receive 1 tablet of 0.25mg Digoxin coadministered with 1 tablet of 20 mg enlicitide/180 mg sodium caprate on Day 1 of Period 1 and will receive 1 tablet of 0.25mg Digoxin on Day 1 of period 2. |
| 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 |
| Name | Type | Description |
|---|---|---|
| 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 |
| lithium carbonate | DRUG | Oral capsule |
| Digoxin | DRUG | Participants will receive 0.25 mg digoxin orally on Day 1 Period 1 in Arm A and Day 1 Period 2 in Arm B. They also receive Digoxin orally on Day 1, Period 2 in Arm A and on Day 1 Period 1 in Arm B coadministered with oral 20 mg enlicitide/180 mg sodium caprate. |
Inclusion Criteria: -Has either not received lipid-lowering therapy (LLT) or has not received certain LLTs within a specified time period prior to the study. Exclusion Criteria: * Has a history of homozygous familial hypercholesterolemia (FH), compound heterozygous FH, or double heterozygous FH. ...
Enlicitide is an investigational small molecule being studied for hepatic insufficiency, hyperlipidemia, and hypercholesterolemia. It is also used in healthy volunteer studies to assess drug interactions, food effects, and formulations. Enlicitide is in Phase 1 clinical development and is not yet approved by the FDA.
Enlicitide is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is conducting Phase 1 clinical trials to evaluate the drug's safety, tolerability, and pharmacokinetics in healthy participants and in people with hepatic insufficiency.
Enlicitide is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Merck has completed seven Phase 1 trials and has one active trial ongoing, with a total of 975 participants enrolled across all studies.
Enlicitide has been studied in several Phase 1 trials, including NCT06597760 (digoxin interaction), NCT06609512 (food effect), NCT06880874 (formulation evaluation), and NCT07481708 (formulation study). These trials enrolled healthy adults in the United States and assessed how the body processes the drug.
Enlicitide is a small molecule with a peptide-like structure, classified under the -tide (peptide) target class. It is being investigated for its effects on lipid metabolism in conditions such as hyperlipidemia and hypercholesterolemia, though its specific molecular target is not disclosed in the available data.
Yes, Enlicitide is also known as MK-0616. Clinical trial records reference both names, such as in NCT06880874, which is titled 'A Clinical Study to Evaluate Enlicitide (MK-0616) Formulations in Healthy Adult Participants.' Both names refer to the same investigational drug.