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PPAR alpha

Phase 2

Dyslipidemia | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Jan 26, 2007

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment300
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00116519A Study in People With Abnormal Fat Levels in the BloodPHASE2 COMPLETED 300Jul 1, 2005Oct 1, 2006Jan 26, 200754 United States
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Study Endpoints
Primary Endpoints
Effects on HDL-C and Triglycerides after 12 weeks
Safety after 12 weeks
Secondary Endpoints
Effects on LDL-C after 12 weeks
Effects on biomarkers of atherosclerosis after 12 weeks
Effects on factors of metabolic syndrome after 12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
PPAR alphaDRUG -
placeboDRUG -
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites54

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 frequ...

Countries:United States
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