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CP-945, 598

Phase 2

Obesity | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Sep 17, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials6
Total Enrollment407

FDA Designations

No designations recorded

Clinical trial landscape

CP-945, 598 · 6 trials · 2 indications

Phase 2 1Phase 1 5
NCT00134199A Study Of 6-Month Duration To Evaluate The Weight Loss Effect Of Various Doses Of CP-945,598 In Obese SubjectsObesity
COMPLETED282 Analytics
PHASE2COMPLETED
A Study Of 6-Month Duration To Evaluate The Weight Loss Effect Of Various Doses Of CP-945,598 In Obese Subjects
ObesityUnlock trial analytics

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 to 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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Frequently asked questions about CP-945, 598

What is CP-945,598 used for?

CP-945,598 is an investigational small molecule being studied for the treatment of obesity. It is a metabolic therapeutic developed by Pfizer, Inc. The drug has been evaluated in clinical trials involving participants with obesity, and it remains in clinical development as an investigational agent.

Who makes CP-945,598?

CP-945,598 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. Pfizer has conducted multiple clinical trials of this investigational small molecule for obesity, including studies in the United States.

What phase is CP-945,598 in?

CP-945,598 is in Phase 2 clinical development for obesity. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy. The drug is not yet available to patients outside of clinical research.

What clinical trials is CP-945,598 in?

CP-945,598 has been studied in six clinical trials, all of which are completed. These include Phase 1 studies such as NCT00472836, NCT00644839, NCT00645021, and NCT00645463, which examined the drug's safety, tolerability, and pharmacokinetics in participants with obesity, including those with renal or hepatic impairment.

Is CP-945,598 a controlled trial drug?

CP-945,598 has been evaluated in randomized, double-blind, controlled clinical trials. The studies were designed to compare the investigational drug against a control, and they included healthy volunteers as well as participants with obesity. All six trials of CP-945,598 have been completed.