CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 381 enrolled
Drug / intervention
Enclitide Chloride +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05261126
NCT05261126Phase 2Completed
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A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia

Merck Sharp & Dohme LLC·interventional·Posted Mar 2, 2022·Updated Dec 9, 2024

In Brief

A Phase 2 clinical trial evaluating Enclitide Chloride and Placebo for Hypercholesterolemia and Familial Hypercholesterolemia. Completed, enrolled 381 participants across 63 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia, Familial Hypercholesterolemia
CountriesGermany, Japan, Mexico, Norway, South Korea, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedMar 2, 2022
Enrollment StartMar 10, 2022
Primary CompletionNov 28, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 4.3 years ago

Interventions

Enclitide Chloridedrug

Enclitide Chloride administered orally

Placebodrug

Placebo matching enclitide chloride administered orally