Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Enlicitide Chloride · 4 trials · 3 indications
Urine samples will be collected to determine the Aeu of \[¹⁴C\]enlicitide chloride.
Fecal samples will be collected to determine the Aef of \[¹⁴C\]enlicitide chloride.
Urine samples will be collected to determine the feu of \[¹⁴C\]enlicitide chloride.
Fecal samples will be collected to determine the fef of \[¹⁴C\]enlicitide chloride.
Plasma samples will be collected to determine the AUC0-t of enlicitide chloride.
Plasma samples will be collected to determine the AUC0-inf of enlicitide chloride.
Plasma samples will be collected to determine the Cmax of enlicitide chloride.
Plasma samples will be collected to determine the t1/2 of enlicitide chloride.
Plasma samples will be collected to determine the Tmax of enlicitide chloride.
Plasma samples will be collected to determine the AUC0-t of total reactivity.
Plasma samples will be collected to determine the AUC0-inf of total reactivity.
Plasma samples will be collected to determine the Cmax of total reactivity.
Plasma samples will be collected to determine the t1/2 of total reactivity.
Plasma samples will be collected to determine the Tmax of total reactivity.
Plasma samples will be collected to determine the enlicitide chloride AUC0-x/total radioactivity AUC0-x.
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
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Blood samples were collected at pre-specified timepoints to determine the AUC0-inf of MK-0616. AUC0-inf was defined as the area under the concentration-time curve of MK-0616 from time zero to infinity.
Blood samples were collected at pre-specified timepoints to determine the AUC0-last of MK-0616. AUC0-last was defined as the area under the concentration-time curve of MK-0616 from time zero to last measurable concentration.
Blood samples were collected at pre-specified time points to determine the Cmax of MK-0616. Cmax was defined as the maximum concentration of MK-0616 reached.
Blood samples were collected at pre-specified timepoints to determine the Tmax of MK-0616. Tmax was defined as time to the maximum concentration of MK-0616 reached.
Blood samples were collected at pre-specified timepoints to determine the t1/2 of MK-0616. t1/2 was defined as the time required to divide the MK-0616 plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-0616.
Blood samples were collected at pre-specified timepoints to determine the CL/F of MK-0616. CL/F was the apparent total clearance of MK-0616 in plasma over time, assessed as the rate at which MK-0616 was removed from the plasma.
Blood samples were collected at pre-specified timepoints to determine the Vz/F of MK-0616. Vz/F was the apparent volume of distribution of MK-0616 between the plasma and the rest of the body, after dose, assessed as the total volume of MK-0616 that would need to be uniformly distributed to achieve the desired plasma drug concentration.
| Arm | Type | Description |
|---|---|---|
| [¹⁴C]Enlicitide chloride | EXPERIMENTAL | Participants will receive a single dose of \[¹⁴C\]enlicitide chloride on Day 1. |
| Enlicitide Chloride Panel A | EXPERIMENTAL | Period 1: Participants will receive a single dose of enlicitide chloride dose 1 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast). Period 2: Participants will receive a single dose of enlicitide chloride dose 1 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast) followed by a standard breakfast. |
| Enlicitide Chloride Panel B | EXPERIMENTAL | Period 1: Participants will receive a single dose of enlicitide chloride dose 2 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast). Period 2: Participants will receive a single dose of enlicitide chloride dose 3 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast). |
| Enlicitide Chloride Panel C | EXPERIMENTAL | Participants will receive enlicitide chloride dose 2 or placebo once daily for 14 days on an empty stomach (after a ≥8-hour overnight fast). |
| Enlicitide Chloride | EXPERIMENTAL | Participants receive enlicitide chloride titrated orally from Dose 1, Dose 2, or Dose 3 once daily (QD) over the course of a 14-day treatment for each dose based on the safety and tolerability of the previous starting dose. The total treatment duration is up to approximately 6 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants receive placebo orally for up to approximately 6 weeks. |
| Panel A - Moderate Renal Impairment (RI) | EXPERIMENTAL | Single dose of enlicitide chloride 10 mg |
| Panel B - Healthy Controls | EXPERIMENTAL | Single dose of enlicitide chloride 10 mg |
| Name | Type | Description |
|---|---|---|
| [¹⁴C]Enlicitide chloride | DRUG | IV Injection |
| Enlicitide Chloride | DRUG | Oral Capsule |
| Placebo | DRUG | Placebo oral capsule matching enlicitide chloride |
Inclusion Criteria: * Is in good health. * Has a body mass index ≥18 and ≤32 kg/m\^2, inclusive. Exclusion Criteria: * Has a history of cancer. * Has positive tests for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus.
Enlicitide Chloride is an investigational oral PCSK9 inhibitor being studied for use in healthy participants, participants with moderate renal impairment, and participants with hypercholesterolemia. It is being developed by Merck & Company, Inc. (MRK) as a potential treatment for conditions related to cholesterol metabolism.
Enlicitide Chloride targets PCSK9, a protein that regulates cholesterol levels by controlling the degradation of LDL receptors. By inhibiting PCSK9, the drug aims to increase the availability of LDL receptors on liver cells, thereby enhancing the clearance of LDL cholesterol from the blood.
Enlicitide Chloride is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety, tolerability, and pharmacokinetics in various patient populations.
Enlicitide Chloride is in Phase 1 clinical development. All four completed trials for the drug are Phase 1 studies, meaning it is still in the early stages of clinical testing and has not yet been evaluated in later-phase efficacy trials.
Enlicitide Chloride has been studied in four completed Phase 1 trials: NCT05070390 in participants with moderate renal impairment, NCT06655311 in healthy participants and those taking statins, NCT06658626 a mass balance study in healthy males, and NCT06814106 in healthy Chinese adult participants.
Yes, Enlicitide Chloride is also known as MK-0616. Clinical trial records refer to the drug as both Enlicitide Chloride and MK-0616, with some studies titled 'A Study of Enlicitide Chloride (MK-0616 Oral PCSK9 Inhibitor)' and others using the MK-0616 designation.