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rimonabant

Phase 3

Obesity | Small molecule | Metabolic |Sanofi|Last Updated: Apr 20, 2009

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 Trials8
Total Enrollment8,245
FDA Designations
No designations recorded
Clinical Trials (8)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00325546Study of Weight-Reducing Effect and Safety of Rimonabant In Obesity in ASIA (RIO-ASIA)PHASE3 COMPLETED 643Apr 1, 2006Apr 1, 2007Apr 7, 20093 China, South Korea +1
NCT00481975Efficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese PatientsPHASE3 COMPLETED 289Aug 1, 2004Aug 1, 2005Apr 7, 20097 United States, Finland +5
NCT00481923Efficacy and Safety of Rimonabant With or Without Hypocaloric Diet in Obese PatientsPHASE3 COMPLETED 156May 1, 2004Apr 1, 2005Apr 20, 20091 United Kingdom
NCT00029848Obese Patients With Type 2 DiabetesPHASE3 COMPLETED 1,045Oct 1, 2001May 1, 2004Apr 20, 200955 United States, Argentina +9
NCT00386061Rimonabant in Obesity Over a 2-Year Duration (RIO-Europe)PHASE3 COMPLETED 1,507Oct 1, 2001Jun 1, 2004Apr 20, 20097 United States, Belgium +5
NCT00029835Obese Patients With Untreated DyslipidemiasPHASE3 COMPLETED 1,033Sep 1, 2001Nov 1, 2003Apr 20, 200935 United States, Australia +6
NCT00029861Obese Patients With or Without Comorbidities (RIO-North America)PHASE3 COMPLETED 3,045Aug 1, 2001Apr 1, 2004Apr 20, 200951 United States, Canada
NCT00459004Japanese Dose-Response Study of Rimonabant in Obese PatientsPHASE2 COMPLETED 527Oct 1, 2004Apr 1, 2006Apr 7, 20091 Japan
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Study Endpoints
Primary Endpoints
Absolute change in weight from baseline to month 9
Change in body weight from baseline to Day 180 visit
Absolute change from baseline in energy intake during ad-libitum dinner of the high-fat probe day at Weeks 3/4 of double-blind treatment.
Change in body weight
change in body weight from baseline to 1 year.
Change from baseline in body weight at 1 year.
absolute change in body weight from baseline to Week 24
Secondary Endpoints
HDL-Cholesterol, triglycerides, fasting-insulin, fasting glucose, waist circumference(physical examination, vital signs, ECG, laboratory tests, adverse events).
Efficacy: binge eating episodes, BES score, TFEQ dimensions, waist circumference, Body Mass Index
Safety: clinical examination, vital signs, adverse events, Hospital Anxiety and Depression (HAD) scale
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Rimonabant (SR141716)DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Body mass index (BMI)\> 25 kg/m² Exclusion Criteria: * Absence of stable weight (variation \< 5 kg) within three months prior to screening visit), * Absence of effective contraceptive method for females of childbearing potential, * Presence of treated or untreated type 1 or ...

Countries:ChinaSouth KoreaTaiwanUnited StatesFinlandFranceNetherlandsPortugalSwedenSwitzerlandUnited KingdomArgentinaBelgiumCanadaCzechiaGermanyPolandAustraliaItalySpainJapan
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