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A Study in People With Abnormal Fat Levels in the Blood

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00116519
Enrollment
300
Registered
2005-06-30
Start date
2005-07-31
Completion date
2006-10-31
Last updated
2007-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

Brief summary

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.

Interventions

DRUGplacebo

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Effects on HDL-C and Triglycerides after 12 weeks
Safety after 12 weeks

Secondary

MeasureTime frame
Effects on LDL-C after 12 weeks
Effects on biomarkers of atherosclerosis after 12 weeks
Effects on factors of metabolic syndrome after 12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026