Obesity MedDRA version: 8.1 Level: LLT Classification code 10029883 Term: Obesity
Conditions
Sponsors
Pfizer Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and/or female subjects between 18 and 70 years of age inclusive. 2. For women of childbearing potential, a negative serum pregnancy test will be required prior to study inclusion. Female subjects must be surgically sterile or be postmenopausal or must agree to use effective contraception during the study. Oral contraceptive use is permitted if used for at least 3 months before starting study medication. Note: The definition of effective contraception will be based on the judgment of the Investigator or a designated associate. 3. Body Mass Index (BMI) =30 kg/m2, for subjects without co-morbidities; =27 kg/m2 for subjects with co-morbidities (treated or untreated hypertension and/or treated or untreated dyslipidemia): a. Hypertension is defined as: a. Systolic BP =140 and/or diastolic BP =90 mm Hg and/or, b. On anti-hypertensive medication. b. Dyslipidemia is defined as: a. LDL-C not at goal according to local guidelines and/or, b. Triglycerides =150 mg/dL and/or, c. HDL-C =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Women who are pregnant or lactating, or who are actively planning to become pregnant. 2.Subjects with clinically significant abnormalities identified during the screening process. Specific exclusions include the following: a.Subjects with clinically significant cardiovascular disease, defined as unstable coronary heart disease (CHD), cerebrovascular disease (CVD) or peripheral vascular disease (PVD) and/or an event/intervention during the past 6 months; Note: Clinically stable subjects with a history of CHD, CVD or PVD, provided that the level of exercise proposed in the trial is deemed safe and appropriate for the subject may be included. b.Subjects with systolic BP =160 and/or diastolic BP =100 mm Hg or requiring new pharmacological treatment or change in current treatment according to local guidelines. c.Subjects with dyslipidemia requiring new pharmacological treatment or change in current treatment according to local guidelines. d.Subjects with diabetes or fasting blood glucose concentration =126 mg/dL. e.Subjects with renal disease including: •Any history of nephrotic syndrome •Chronic renal failure and/or serum creatinine >1.5 times the upper limit of normal (ULN). f.Subjects with abnormal screening TSH values. g.Subjects with significant hepatobiliary disease including: •History of hepatitis B or C infection and/or •Aspartate aminotransferase or alanine aminotransferase =2 times the ULN. h.History of HIV infection or use of anti-retroviral agents. i.Subjects with any prior history of malignancy except for: •Basal cell carcinoma of the skin curatively treated, •Other malignancies (regardless of site) that have been cancer-free for greater than 5 years prior to screening. j.Subjects with gastrointestinal disease, surgery limiting drug absorption or previous history of surgical procedure for weight loss. k.Clinical laboratory tests outside the pre-specified exclusionary limits. l.Subjects with a history of CNS disorder including: •A mood disturbance that meets the criteria for a Major Depressive Disorder within the last 10 years prior to screening, defined as requiring hospitalization, two or more episodes of a major depressive disorder or any previous suicide attempt. •Use of antidepressants that are known to increase weight; Note: Subjects on a maintenance dose of a permitted antidepressant for a major depressive disorder, stable and in remission for at least 3 months prior to screening, and who plan to continue this treatment during the entire trial may be included. •Subjects with a score of =10 or who score positively on the item 9 addressing suicidal ideas on the PHQ-9. •Subjects with psychotic conditions or on antipsychotic pharmacotherapy. •Subjects with seizure disorders who: 1.Are not controlled by current antiepileptic treatment, 2.Are taking antiepileptic drugs (AEDs) known to affect weight positively (eg, valproic acid) or negatively (eg, topiramate, zonisamide) unless these medications have been taken at a stable dose for at least 6 months and the subject’s weight has been stable over the same time period. •Subjects with neurological disorders that are acute, chronic relapsing, progressive or have an unpredictable course. 3.Subjects who frequently change smoking habits or have stopped smoking within 6 months prior to screening. 4.Subjects who use marijuana (determined by medical history). 5.Subje
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the effect of CP-945,598 on; • Percent change in body weight at Year 1; • Proportion of subjects who lose 5% of body weight at Year 1.;Secondary Objective: Secondary Clinical Objectives Determine the effect of CP-945,598 on: • Percent change in body weight at Year 2; • Proportion of subjects who lose 10% body weight at Year 1; • Changes in waist circumference at Year 1; • Changes in HDL and triglycerides at Year 1. Secondary Patient Reported Outcomes Objectives Determine the effect of CP-945,598 on Changes in Patient Reported Outcome Scales at 1 year: • --Uncontrolled Eating (from the Three Factor Eating Questionnaire R 21) and; • --Power of Food (from the Power of Food Scale, USA or AMOTPIOTFE, ex USA).;Primary end point(s): Co-Primary Endpoints • Percent change in body weight from Baseline (Day 1) to end of Year 1. • Proportion of subjects whose lose 5% of body weight at Year 1. | — |
Countries
France, Germany, Sweden, United Kingdom
Outcome results
None listed