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PPAR alpha

Phase 2

Dyslipidemia | Small molecule | Cardiovascular |Eli Lilly and Company|Last Updated: May 15, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

Clinical trial landscape

PPAR alpha · 3 trials · 3 indications

Phase 2 3
NCT00374855A Study in People With Mild HypertensionMild Hypertension
COMPLETED153 Analytics
NCT00116519A Study in People With Abnormal Fat Levels in the BloodDyslipidemia
COMPLETED300 Analytics
NCT00133380A Study in People With High CholesterolHypercholesterolemia
COMPLETED300 Analytics
PHASE2COMPLETED
A Study in People With Mild Hypertension
Mild HypertensionUnlock trial analytics
PHASE2COMPLETED
A Study in People With Abnormal Fat Levels in the Blood
DyslipidemiaUnlock trial analytics
PHASE2COMPLETED
A Study in People With High Cholesterol
HypercholesterolemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

To test the hypothesis that LY518674, administered for 6 weeks to patients with mild hypertension, reduces 24-hour mean ambulatory Systolic Blood Pressure, compared with placebo.
Effects on HDL-C and Triglycerides after 12 weeks
Safety after 12 weeks
Effects on "bad" cholesterol, LDL-C, after 12 weeks

Secondary Endpoints

Determine the duration and consistency of the reduction in BP over the course of a day, relative to placebo, after 6 weeks of treatment with LY518674 when taken once daily
Evaluate the population dose and exposure response relationships of LY518674 for lowering the mean SBP and DBP during the 24 hour period, using ABPM during a 6 week treatment period
Evaluate the population dose, exposure, and time response relationships of LY518674 for lowering the mean SBP and DBP during the 8 hour awake period, using ABPM during a 6 week treatment and following cessation of dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
PPAR alphaDRUG -
HydrochlorothiazideDRUG -
PlaceboDRUG -
atorvastatinDRUG -
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: 1. Are men and women between 18 and 70 years of age, inclusive 2. Have given signed informed consent to participate in this study 3. Are diagnosed with mild essential hypertension at screening (currently untreated or treated with monotherapy) Exclusion Criteria: 1. Secondary o...

Countries:SwedenUnited States
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Frequently asked questions about PPAR alpha

What is PPAR alpha used for?

PPAR alpha is an investigational small molecule being developed by Eli Lilly and Company for cardiovascular conditions, including dyslipidemia, mild hypertension, and hypercholesterolemia. It is currently in Phase 2 clinical development and is not yet approved by the FDA.

What does PPAR alpha target?

PPAR alpha is a small molecule that targets the PPAR alpha receptor, a nuclear receptor involved in lipid metabolism. By activating this receptor, it is intended to address abnormal fat levels in the blood and related cardiovascular conditions.

Who makes PPAR alpha?

PPAR alpha is being developed by Eli Lilly and Company, a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol LLY. The drug is currently in Phase 2 clinical trials for cardiovascular indications.

What phase is PPAR alpha in?

PPAR alpha is in Phase 2 clinical development. It has completed three Phase 2 trials, and it remains an investigational drug, meaning it has not received FDA approval and is still being studied for safety and efficacy.

What clinical trials is PPAR alpha in?

PPAR alpha has completed three Phase 2 clinical trials: NCT00116519 in dyslipidemia, NCT00133380 in hypercholesterolemia, and NCT00374855 in mild hypertension. These trials were conducted in the United States and Sweden, with enrollment ranging from 153 to 300 participants.

Is PPAR alpha the same as any other drug?

PPAR alpha is not known by any alternative names. It is a distinct investigational compound developed by Eli Lilly and Company, and no other names for this drug have been reported.