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AVE1625 B

Phase 2

Obesity | Small molecule | Metabolic |Sanofi|Last Updated: Dec 19, 2008

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment345
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00345410Dose-Ranging Study Evaluating AVE1625 in Abdominally Obese Patients With Atherogenic DyslipidemiaPHASE2 COMPLETED 345Jun 1, 2006Jun 1, 2007Dec 19, 20081 United States
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Study Endpoints
Primary Endpoints
Absolute change from baseline in body weight at 24 weeks
Secondary Endpoints
- relative change from baseline to 24 weeks in plasma HDL-cholesterol and triglycerides levels ; - change from baseline to 24 weeks in waist circumference ; Other criteria: glycemic control parameters.
Safety: physical examination, vital signs, adverse events, ECG, laboratory tests.
Pharmacokinetics: plasma AVE1625 concentrations
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
AVE1625 BDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Abdominal obese patients with · * Waist circumference \> 102 cm in men and \>88 cm in women * Dyslipidemia consisting of : * Triglycerides ≥ 1.50 g/L (i.e 1.69 mmol/L) and ≤ 7.0 g/L(i.e. 7.90 mmol/L)AND/OR * HDL-cholesterol \< 50 mg/dL (i.e. 1.29 mmol/L) in women and \< 4...

Countries:United States
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