Brief Summary

The primary purpose of your participation in this study is to help answer the following research question(s)

Whether LY2484595 in combination with a statin drug (atorvastatin, simvastatin or rosuvastatin; currently used to treat abnormal fat or cholesterol in blood) improves the blood fat profile more than statins alone.
Whether LY2484595 alone improves blood fats profile compared to sugar pills.
Whether LY2484595 interferes with break down or functioning of statins.
Whether LY2484595 has any side effects that would not support testing it in future studies.

Trial Health

On Track

Trial Health Score

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

Enrollment

398

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Apr 2010

Shorter than P25 for phase_2

Geographic Reach

6 countries

59 active sites

Status

completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

Study Start

First participant enrolled

April 1, 2010

Completed

14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2010

Completed

4 days until next milestone

First Posted

Study publicly available on registry

April 19, 2010

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed

6.8 years until next milestone

Results Posted

Study results publicly available

March 22, 2018

Completed

Last Updated

March 22, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

April 15, 2010

Results QC Date

February 18, 2018

Last Update Submit

February 18, 2018

Conditions

Dyslipidemia

Keywords

DyslipidemiasMixed dyslipidemiaHypercholesterolemiaAtherosclerosisAtorvastatinSimvastatinRosuvastatinMetabolic DiseasesAntilipemic AgentsEnzyme InhibitorsAnticholesteremic AgentsCholesteryl Ester Transfer Protein InhibitorsCholesteryl EsterLipid Metabolism Disorders

Outcome Measures

Primary Outcomes (2)

Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Baseline, Week 12
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Baseline, Week 12

Secondary Outcomes (15)

Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 and Placebo
Baseline, Week 12
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo
Baseline, Week 12
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy
Baseline, Week 12
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy
Baseline, Week 12
Pharmacokinetics - LY2484595 Area Under the Concentration-Time Curve (AUC) at Steady-State
Baseline up to 12 weeks
+10 more secondary outcomes

Study Arms (10)

30 milligram (mg) LY2484595 monotherapy

EXPERIMENTAL

Drug: LY2484595Drug: Placebo for Statins

100 mg LY2484595 monotherapy

EXPERIMENTAL

Drug: LY2484595Drug: Placebo for Statins

500 mg LY2484595 monotherapy

EXPERIMENTAL

Drug: LY2484595Drug: Placebo for Statins

Placebo

PLACEBO COMPARATOR

Drug: Placebo for LY2484595Drug: Placebo for Statins

20 mg Atorvastatin monotherapy

ACTIVE COMPARATOR

Drug: AtorvastatinDrug: Placebo for LY2484595

100 mg LY2484595 + 20 mg Atorvastatin

EXPERIMENTAL

Drug: LY2484595Drug: Atorvastatin

40 mg Simvastatin monotherapy

ACTIVE COMPARATOR

Drug: SimvastatinDrug: Placebo for LY2484595

100 mg LY2484595 + 40 mg Simvastatin

EXPERIMENTAL

Drug: LY2484595Drug: Simvastatin

10 mg Rosuvastatin monotherapy

ACTIVE COMPARATOR

Drug: RosuvastatinDrug: Placebo for LY2484595

100 mg LY2484595 + 10 mg Rosuvastatin

EXPERIMENTAL

Drug: LY2484595Drug: Rosuvastatin