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CP-866,087

Phase 2

Obesity | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Oct 1, 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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment94
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00479492Study To Determine The Effects And Safety Of A Weight Loss Compound On Overweight, Otherwise Healthy, VolunteersPHASE2 COMPLETED 94Jun 1, 2007Jan 1, 2008Oct 1, 20094 United States
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Study Endpoints
Primary Endpoints
Measure the effect of weight loss over 12 weeks in overweight otherwise healthy patients. Measurements will include body weight and waist circumference. Measurements will occur at Day 1, 7, 14, 28, 42, 56, 70, 84 and 94.
94 days
Secondary Endpoints
To characterize the effect of 4 weeks of dosing of 3 different doses of CP-866,087 on 24-hour urinary cortisol levels. Measured at Day 1 and Day 29
29 days
Exploratory biomarkers measured at Day 1, 14, 28, 56, and 84.
84 days
Waist circumference measured at Day 1, 7, 14, 28, 42, 56, 70, 84, 94.
94 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
CP-866,087DRUG1 mg of CP-866,087, administered QD for 84 days
placeboDRUGplacebo administered QD for 84 days
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Body Mass Index (BMI) 30 to 40 kg/m2 and total body weight of \>110 lbs. * Otherwise healthy Exclusion Criteria: * Women must be of non-childbearing potential. * Significant current or history of medical illness.

Countries:United States
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