A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)

Summary

The purpose of this study is to evaluate the efficacy and safety of enclitide chloride, an oral PCSK9 inhibitor, in lowering low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia. The primary hypothesis is that at least one of the four doses of enclitide chloride tested in this study is superior to placebo on percent change from baseline in LDL-C at Week 8.

Timeline

Start

2022-03-10

Primary completion

2022-11-28

Completion

2022-11-28

Outcome

Met primary endpoint

registry analysis (superiority test); MK-0616 6 mg vs Placebo; p <0.001; Difference in Least Squares Means -41.2 (95% CI -47.8 to -34.7); cLDA NCT05261126 ↗

paper all doses of MK-0616 demonstrated statistically significant (P < 0.001) differences in least squares mean percentage change in LDL-C PMID 36889610 ↗

Publications

• Results Ballantyne CM, Banka P, Mendez G, Garcia R, Rosenstock J, Rodgers A, Mendizabal G, Mitchel Y, Catapano AL. Phase 2b Randomized Trial of the Oral PCSK9 Inhibitor MK-0616. J Am Coll Cardiol. 2023 Apr 25;81(16):1553-1564. doi: 10.1016/j.jacc.2023.02.018. Epub 2023 Mar 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enclitide	Unknown	6 mg	Oral
Subject	Enclitide	Unknown	12 mg	Oral
Subject	Enclitide	Unknown	18 mg	Oral
Subject	Enclitide	Unknown	30 mg	Oral

Indications