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CP-945,598

Phase 2

Obesity | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Sep 17, 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-BlindCONTROLLEDBiomarker
Total Trials6
Total Enrollment407
FDA Designations
No designations recorded
Clinical Trials (6)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00134199A Study Of 6-Month Duration To Evaluate The Weight Loss Effect Of Various Doses Of CP-945,598 In Obese SubjectsPHASE2 COMPLETED 282 — — Mar 1, 2005Nov 1, 2005Aug 12, 200915 United States
NCT00644839Study Examing The Effect Of Omeprazole On Safety, Tolerability And How The Body Processes An Experimental DrugPHASE1 COMPLETED 28 — — Apr 1, 2008Jul 1, 2008Aug 13, 20091 United States
NCT00645021Study Examining The Effect Of Hepatic Impairment On Safety, Toleration And How The Body Processes An Experimental DrugPHASE1 COMPLETED 24 — — Apr 1, 2008Oct 1, 2008Aug 27, 20092 United States
NCT00472836Study Examining The Effect Of Renal Impairment On Safety, Toleration And How The Body Processes An Experimental DrugPHASE1 COMPLETED 17 — — Jun 1, 2007Oct 1, 2008Aug 13, 20092 United States
NCT00645216Study Examing The Effect of Grapefruit Juice On The Blood And Urine Samples of Study Drug And Its By Product And SafetyPHASE1 COMPLETED 28 — — Jun 1, 2007Oct 1, 2007Aug 10, 20091 United States
NCT00645463Effect of Diltiazem Administration on CP-945,598 PharmacokineticsPHASE1 COMPLETED 28 — — Mar 1, 2007Jun 1, 2007Sep 17, 20091 United States
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Study Endpoints
Primary Endpoints
Determine the effect of various doses of CP 945,598 on body weight in obese subjects after 24 weeks of dosing
Measurement of drug concentrations in serum from blood samples collected at 4 days before given omeprazole, and after second single dose of CP-945,598 on days 1-6, 8.
1 day
Measurement of drug concentrations in serum from blood samples collected at various times after first single dose of CP-945,598 on days 1-6, 8, 15.
1 day
Measurement of drug and metabolite concentrations in serum collected at various times over 24 hour dosing interval on Days 1 and 14, before daily dose on days 5-7, 13, following stopping of drug treatment on days 15-18, 21, 28, and 35
14 days
Measurement of drug and metabolite concentrations in serum from blood samples collected at various times over 24 hour dosing interval on Days 1 & 14, before daily dose on days 2, 5-7, 13, following stopping of drug treatment on days 15-18, 21,
14 days
28, 35
14 days
Measurement of durg and metabolite concentrations in serum from blood sampling collected at various times over 24 hours dosing interval on Day 7 and 21, before dosing on days 5,6, 12, 13, 14, 19 and 20.
21 days
Safetey laboratory tests (chemistry, hematology, urinalysis) on Days -1 and 22
21 days
Adverse event monitoring throughout duration of the study
21 days
Pharmacokinetic parameters of CP-945,598 and its metabolite, CE-156,706, (AUCtau, Cmax and Tmax)
Days 7 and 28
Safety endpoints including adverse event monitoring, physical examinations, vital signs, ECGs, and clinical laboratory tests.
28 days
Secondary Endpoints
Evaluate the safety and tolerability of CP 945,598 in a 26 week outpatient setting;; -Explore the effect of CP 945,598 on: waist circumference, PD measurements of selected biochemical variables related to energy deficit and weight loss includ
ECGs on the first and last day of the study
2 days
Saftey laboratory tests (chemistry, hematology, urinalysis) on the first and last day of the study
2 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CP-945,598EXPERIMENTAL -
Mild hepatic functionEXPERIMENTAL -
Moderate hepatic functionEXPERIMENTAL -
Normal hepatic functionEXPERIMENTAL -
Normal renal functionEXPERIMENTAL -
Severe renal impairmentEXPERIMENTAL -
CP-945,598 with Grapefruit JuiceEXPERIMENTALCP-945,598 with Grapefruit Juice
CP-945,598 aloneEXPERIMENTALCP-945,598 alone
Group AEXPERIMENTAL -
Group BEXPERIMENTAL -
Interventions
NameTypeDescription
CP-945,598DRUG -
sibutramineDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Male and/or female subjects without clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12 lead ECG and clinical laboratory tests * Body Mass Index (BMI) ³30 and \<40 kg/m...

Countries:United States
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