NCT05261126

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

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 381 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia
• Familial Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Enclitide Chloride	Enclitide Chloride administered orally
DRUG	Placebo	Placebo matching enclitide chloride administered orally

Timeline

• Start date: 2022-03-10
• Primary completion: 2022-11-28
• Completion: 2022-11-28
• First posted: 2022-03-02
• Last updated: 2024-12-09
• Results posted: 2023-12-06

Locations

63 sites across 8 countries: United States, Germany, Japan, Mexico, Norway, South Korea, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study