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PPAR alpha

Phase 2

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

PPAR alpha development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Jun 2005

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials3
Total Enrollment753

FDA Designations

No designations recorded

PPAR alpha clinical trials

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 studied for cardiovascular conditions, including hypercholesterolemia, mild hypertension, and dyslipidemia. It has completed Phase 2 clinical trials in these indications. The drug is not approved and remains in clinical development.

Who makes PPAR alpha?

PPAR alpha is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the NYSE under the ticker LLY. The company has conducted Phase 2 clinical trials of the drug for cardiovascular indications.

What phase is PPAR alpha in?

PPAR alpha is in Phase 2 clinical development. It has completed Phase 2 trials in dyslipidemia, hypercholesterolemia, and mild hypertension. The drug is investigational and has not been approved for any use.

What clinical trials is PPAR alpha in?

PPAR alpha has completed three Phase 2 trials. NCT00116519 studied the drug in people with dyslipidemia in the United States. NCT00133380 studied it in people with high cholesterol in the United States. NCT00374855 studied it in people with mild hypertension in Sweden.

Is PPAR alpha the same as any other drug?

PPAR alpha is the name used for this investigational drug in clinical trials. No alternative names have been reported for this asset. It is a small molecule being studied for cardiovascular conditions.