Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

527

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jun 2013

Shorter than P25 for phase_2

Geographic Reach

8 countries

49 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1 year study duration

Study Start

First participant enrolled

June 1, 2013

Completed

26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2013

Completed

5 days until next milestone

First Posted

Study publicly available on registry

July 2, 2013

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed

3.1 years until next milestone

Results Posted

Study results publicly available

June 21, 2017

Completed

Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

10 months

First QC Date

June 27, 2013

Results QC Date

May 25, 2017

Last Update Submit

September 9, 2019

Conditions

Hypercholesterolemia

Keywords

low density lipoprotein, heterozygous familial hypercholesterolemia, polygenic hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Least square (LS) Means was calculated using analysis of covariance (ANCOVA) adjusted for disease classification, statin dose, baseline LDL-C measurement. Percent change from baseline response is the dependent variable.
Baseline, Week 16

Secondary Outcomes (9)

Percentage Change From Baseline in LDL-C, Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Non-HDL-C
Baseline, Week 16
Percentage Change From Baseline in Apolipoprotein A1 (Apo A1), Apolipoprotein B (Apo B)
Baseline, Week 16
Percentage Change From Baseline in Lipoprotein(a) [Lp(a)]
Baseline, Week 16
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)
Baseline, Week 16
Number of Participants Who Develop Treatment Emergent Anti-LY3015014 Antibodies
Baseline through Week 24
+4 more secondary outcomes

Study Arms (6)

20 mg LY3015014 Q4W

EXPERIMENTAL

20 milligrams (mg) LY3015014 given subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.