Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-02-25 @ 4:48 PM
Study NCT ID:
NCT00479492
Status:
COMPLETED
Last Update Posted:
2009-10-01
First Post:
2007-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study To Determine The Effects And Safety Of A Weight Loss Compound On Overweight, Otherwise Healthy, Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000626492', 'term': 'CP-866,087'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'dispFirstSubmitDate': '2009-09-29', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-29', 'studyFirstSubmitDate': '2007-05-24', 'dispFirstSubmitQcDate': '2009-09-29', 'studyFirstSubmitQcDate': '2007-05-24', 'dispFirstPostDateStruct': {'date': '2009-10-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2009-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': '94 days'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': '29 days'}, {'measure': 'Exploratory biomarkers measured at Day 1, 14, 28, 56, and 84.', 'timeFrame': '84 days'}, {'measure': 'Waist circumference measured at Day 1, 7, 14, 28, 42, 56, 70, 84, 94.', 'timeFrame': '94 days'}, {'measure': 'To explore changes in pharmacodynamics (PD) markers of efficacy resulting from multiple PO doses of CP-866,087, including waist circumference, and serum lipids and exploratory biomarkers.', 'timeFrame': '94 days'}, {'measure': 'Serum Lipids measured at Day 1, 7, 14, 28, 56, 84 and 94.', 'timeFrame': '94 days'}, {'measure': 'To explore the effects of chronic, 12-week dosing with CP-866,087 on neuroendocrine endpoints, including testosterone, TSH, T4, and IGF1. Measured at Day 1, 28, 84 and 94.', 'timeFrame': '94 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity, weight loss'], 'conditions': ['Obesity']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5051019&StudyName=Study%20To%20Determine%20The%20Effects%20And%20Safety%20Of%20A%20Weight%20Loss%20Compound%20On%20Overweight%2C%20Otherwise%20Healthy%2C%20Volunteers', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether CP-866,087 is effective in the weight loss of overweight patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) 30 to 40 kg/m2 and total body weight of \\>110 lbs.\n* Otherwise healthy\n\nExclusion Criteria:\n\n* Women must be of non-childbearing potential.\n* Significant current or history of medical illness.'}, 'identificationModule': {'nctId': 'NCT00479492', 'briefTitle': 'Study To Determine The Effects And Safety Of A Weight Loss Compound On Overweight, Otherwise Healthy, Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A 12-Week, Randomized, Subject And Investigator Blind, Placebo-Controlled Trial To Evaluate The Effect Of CP-866,087 On Weight Loss In Obese, Otherwise Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'A5051019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: CP-866,087']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: CP-866,087']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Drug: CP-866,087']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'CP-866,087', 'type': 'DRUG', 'description': '1 mg of CP-866,087, administered QD for 84 days', 'armGroupLabels': ['1']}, {'name': 'CP-866,087', 'type': 'DRUG', 'description': '5 mg of CP-866,087, administered QD for 84 days', 'armGroupLabels': ['2']}, {'name': 'CP-866,087', 'type': 'DRUG', 'description': '10 mg of CP-866,087, administered QD for 84 days', 'armGroupLabels': ['3']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo administered QD for 84 days', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '49007', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}