CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 527 enrolled
Drug / intervention
LY3015014 +3 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/NCT01890967
NCT01890967Phase 2Completed

A Phase 2 Efficacy and Safety Dose-Ranging Study of LY3015014 in Patients With Primary Hypercholesterolemia

Eli Lilly and Company·interventional·Posted Jul 2, 2013·Updated Sep 18, 2019

In Brief

A Phase 2 clinical trial evaluating LY3015014, Placebo, and 2 other interventions for Hypercholesterolemia. Completed, enrolled 527 participants across 49 sites in 8 countries.

Detailed Summary

This study is designed to define the amount and duration of cholesterol lowering and to assess the safety and tolerability of different dose regimens of LY3015014 in participants with high cholesterol. The study will also investigate how the body processes the drug and how the drug affects the body. Participants will remain on a stable diet and will continue taking cholesterol-lowering medications (statins with or without ezetimibe). After signing the informed consent document, the participant will complete a screening/run-in period that will last at most 8 weeks. Then, the treatment period will last approximately 16 weeks. After the treatment period, the participants will complete a follow-up period lasting approximately 8 weeks for a total study duration ranging from approximately 25 to 32 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Czechia, Denmark, Japan, Netherlands, Poland, Puerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 2, 2013
Enrollment StartJun 1, 2013
Primary CompletionApr 1, 2014
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13 years ago

Interventions

LY3015014drug

Administered SC

Placebodrug

Administered SC

Statindrug

Administered orally

Ezetimibedrug

Administered orally