Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MK-0616
Enclitide Chloride · 2 trials · 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.
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 |
|---|---|---|
| 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 |
| 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 |
|---|---|---|
| Enclitide Chloride | DRUG | Enclitide Chloride administered orally |
| Placebo | DRUG | Placebo matching enclitide chloride administered orally |
| MK-0616 | DRUG | oral administration |
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...
Top 12 of 15 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 4 | PHASE3 | Enlicitide |
| Novartis AG Sponsored ADR | NVS | 14 | PHASE3 | Inclisiran, Pelacarsen, DII235, QCZ484 |
| AstraZeneca PLC | AZN | 3 | PHASE3 | AZD0780, Laroprovstat, Rosuvastatin |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 5 | PHASE3 | Plozasiran, zodasiran, VSA003 |
| Ionis Pharmaceuticals, Inc. | IONS | 2 | PHASE3 | Olezarsen, ION775 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE2 | Alirocumab |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Solbinsiran |
| MediciNova, Inc. | MNOV | 1 | PHASE2 | MN-001 |
| Verve Therapeutics, Inc. | VERV | 4 | PHASE2 | VERVE-102, VERVE-201 |
| NewAmsterdam Pharma Company N.V. | NAMS | 1 | PHASE1 | Obicetrapib |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX310 |
| Esperion Therapeutics, Inc. | ESPR | 1 | - | Bempedoic acid+ Ezetimibe |
Enclitide Chloride is being developed for the treatment of hypercholesterolemia, including familial hypercholesterolemia. It is an investigational oral therapy studied in adults with elevated cholesterol levels. The drug has been evaluated in a Phase 2 clinical trial but is not yet approved for any indication.
Enclitide Chloride is an oral PCSK9 inhibitor. It belongs to the peptide drug class, as indicated by the -tide suffix. By inhibiting PCSK9, it is designed to lower cholesterol levels in patients with hypercholesterolemia. The exact mechanism of action is consistent with other PCSK9 inhibitors.
Enclitide Chloride is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck is responsible for the clinical development of this oral PCSK9 inhibitor for hypercholesterolemia.
Enclitide Chloride is in Phase 2 clinical development. A Phase 2 trial has been completed, but the drug is not yet approved by the FDA or any regulatory agency. It remains an investigational therapy for hypercholesterolemia.
Enclitide Chloride has been studied in a Phase 2 clinical trial, NCT05261126, titled "A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)." This completed trial enrolled 381 participants across multiple countries, including the United States, Germany, Japan, Mexico, Norway, South Korea, Turkey, and the United Kingdom.
Yes, Enclitide Chloride is also known as MK-0616. The clinical trial identifier NCT05261126 refers to it as MK-0616 Oral PCSK9 Inhibitor. Both names refer to the same investigational drug developed by Merck for hypercholesterolemia.