A Study in People With Abnormal Fat Levels in the Blood

Condition(s) targeted: Dyslipidemia

Intervention: PPAR alpha (Drug); placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday - Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

The purposes of this study are to determine:

- The safety of the study medication and any side effects that might be associated with

it;

- Whether the study medication can help patients with low levels of 'good' cholesterol

(HDL-C) and high blood fats or triglycerides (TG);

- How much of the study medication should be given to patients;

- How the study medication compares to fenofibrate (Lofibra), a drug used for people with

low levels of HDL-C and high levels of TG.

Official title: PPAR Alpha: A Phase 2 Dose-Finding and Safety Study for Atherogenic Dyslipidemia by Eli Lilly

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Effects on HDL-C and Triglycerides after 12 weeks

Safety after 12 weeks

Secondary outcome:

Effects on LDL-C after 12 weeks

Effects on biomarkers of atherosclerosis after 12 weeks

Effects on factors of metabolic syndrome after 12 weeks

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men and women between 18 and 80 years of age

- People with abnormal fat levels in the blood (low HDL, high TG)

Exclusion Criteria:

- People with diabetes

- People whose blood pressure is greater than 160/95 mm Hg, on or off blood pressure

medicine

- People who have had frequent chest pain or unstable angina, a heart attack or a heart

procedure, including stent placement, within the past 3 months

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Starting date: July 2005
Ending date: October 2006
Last updated: January 24, 2007