Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Enclitide Chloride · 1 trial · 2 indications
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...
Enclitide Chloride is an investigational small molecule being developed for hypercholesterolemia, a condition of high cholesterol levels. It is also being studied in familial hypercholesterolemia, a genetic form of the condition. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Enclitide Chloride 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 efficacy and safety of this investigational drug for the treatment of hypercholesterolemia.
Enclitide Chloride is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The drug is being studied for its efficacy and safety in adults with hypercholesterolemia, including those with familial hypercholesterolemia.
Enclitide Chloride has one completed Phase 2 clinical trial, identified as NCT05261126. This study, titled 'A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)', enrolled 381 participants across multiple countries including the United States, Germany, Japan, and the United Kingdom.
Enclitide Chloride is an oral PCSK9 inhibitor, meaning it targets the proprotein convertase subtilisin/kexin type 9 enzyme. By inhibiting PCSK9, the drug aims to lower cholesterol levels in patients with hypercholesterolemia. This mechanism is being evaluated in a Phase 2 clinical trial for efficacy and safety.
Yes, Enclitide Chloride is also known as MK-0616. The clinical trial NCT05261126 refers to the drug as 'Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor)', confirming that both names refer to the same investigational compound being developed by Merck for hypercholesterolemia.