{"protocolSection":{"identificationModule":{"nctId":"NCT00500370","orgStudyIdInfo":{"id":"H8O-MC-GWBP"},"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients","officialTitle":"A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients"},"statusModule":{"statusVerifiedDate":"2015-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2007-06"},"primaryCompletionDateStruct":{"date":"2008-02","type":"ACTUAL"},"completionDateStruct":{"date":"2008-02","type":"ACTUAL"},"studyFirstSubmitDate":"2007-07-10","studyFirstSubmitQcDate":"2007-07-10","studyFirstPostDateStruct":{"date":"2007-07-12","type":"ESTIMATED"},"resultsFirstSubmitDate":"2009-02-26","resultsFirstSubmitQcDate":"2009-07-30","resultsFirstPostDateStruct":{"date":"2009-09-04","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-03-19","lastUpdatePostDateStruct":{"date":"2015-04-07","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"AstraZeneca","class":"INDUSTRY"},"collaborators":[{"name":"Eli Lilly and Company","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This is a multicenter study designed to compare the effect of exenatide plus a lifestyle modification plan versus placebo plus a lifestyle modification plan on weight loss in non-diabetic, obese subjects."},"conditionsModule":{"conditions":["Obesity"],"keywords":["exenatide","obesity","diabetes","Amylin","Lilly"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":163,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Group A","type":"EXPERIMENTAL","interventionNames":["Drug: exenatide"]},{"label":"Group B","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"exenatide","description":"subcutaneous injection (5mcg or 10mcg), twice a day","armGroupLabels":["Group A"],"otherNames":["Byetta"]},{"type":"DRUG","name":"placebo","description":"subcutaneous injection (equivalent volume to active dose), twice a day","armGroupLabels":["Group B"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Body Weight","description":"Change in body weight from baseline after 24 weeks of treatment (i.e., body weight at week 24 minus body weight at week 0)","timeFrame":"24 weeks"}],"secondaryOutcomes":[{"measure":"Change in Body Mass Index (BMI)","description":"Change in BMI from baseline after 24 weeks of treatment (i.e., BMI at week 24 minus BMI at week 0)","timeFrame":"24 weeks"},{"measure":"Change in Waist-to-hip Ratio","description":"Waist-to-hip ratio at week 24 compared to waist-to-hip ratio at week 0 (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio equals waist circumference at given time point divided by hip circumference at given timepoint.","timeFrame":"24 weeks"},{"measure":"Percentage of Patients Experiencing >=5% Weight Loss","description":"Percentage of exenatide and placebo treated patients experiencing \\>=5% weight loss after 24 weeks of treatment (i.e., \\[weight at week 0 minus weight at week 24\\] divided by weight at week 0 times 100% \\>=5%)","timeFrame":"24 weeks"},{"measure":"Change in Total Cholesterol","description":"Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0)","timeFrame":"24 weeks"},{"measure":"Change in High Density Lipoprotein (HDL) Cholesterol","description":"Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0)","timeFrame":"24 weeks"},{"measure":"Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed)","description":"Ratio of triglycerides at week 24 compared to triglycerides at week 0 (i.e., triglycerides at week 24 divided by triglycerides at week 0)","timeFrame":"24 weeks"},{"measure":"Change in Low Density Lipoprotein (LDL) Cholesterol","description":"Change in LDL cholesterol from baseline following 24 weeks of treatment (i.e., LDL cholesterol at week 24 minus LDL cholesterol at week 0)","timeFrame":"24 weeks"},{"measure":"Change in Fasting Serum Glucose","description":"Change in fasting serum glucose from baseline following 24 weeks of treatment (i.e., fasting serum glucose at week 24 minus fasting serum glucose at week 0)","timeFrame":"24 weeks"},{"measure":"Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT)","description":"Change in serum glucose AUC following OGTT (week 24 compared to week 0) (i.e., serum glucose AUC at week 24 minus serum glucose AUC at week 0)","timeFrame":"24 weeks"},{"measure":"Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Beta Cell (HOMA-B) (Logarithmically Transformed)","description":"Ratio of HOMA-B at week 24 to HOMA-B at week 0 (i.e., HOMA-B at week 24 divided by HOMA-B at week 0). HOMA-B is a measure of beta cell function.","timeFrame":"24 weeks"},{"measure":"Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) (Logarithmically Transformed)","description":"Ratio of HOMA-S at week 24 to HOMA-S at week 0 (i.e., HOMA-S at week 24 divided by HOMA-S at week 0). HOMA-S is a measure of insulin sensitivity.","timeFrame":"24 weeks"},{"measure":"Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis","description":"Number of patients in each treatment group that demonstrate overt signs of diabetes mellitus diagnosis by week 24","timeFrame":"24 weeks"},{"measure":"Incidence of Patients That Demonstrate Normalization of Impaired Fasting Glucose (IFG) and/or Impaired Glucose Tolerance (IGT)","description":"Number of patients in each treatment group that demonstrate normalization of IFG and/or IGT by week 24","timeFrame":"24 weeks"},{"measure":"Change in High Sensitivity C-reactive Protein (hsCRP)","description":"Change in hsCRP levels from baseline following 24 weeks of treatment (i.e., hsCRP at week 24 minus hsCRP at week 0)","timeFrame":"24 weeks"},{"measure":"Change in Glycosylated Hemoglobin (HbA1c)","description":"Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)","timeFrame":"24 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have a Body Mass Index (BMI) \\>= 30kg/m\\^2\n\nExclusion Criteria:\n\n* Have ever participated in this study previously, or any other study using exenatide (AC2993/LY2148568) or GLP-1 analogs\n* Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start (this criterion includes drugs that have not received regulatory approval for any indication at the time of study entry)\n* Diagnosis of diabetes mellitus (other than gestational diabetes), or previous use of anti-diabetic medications for \\> 3 months\n* Have had a change in prescribed lipid-lowering or blood pressure agents within 4 weeks of screening\n* Used drugs for weight loss (e.g., Xenical \\[orlistat\\], Meridia \\[sibutramine\\], Acutrim \\[phenylpropanolamine\\], Accomplia \\[rimonabant\\], Alli \\[low-dose orlistat\\], or other similar over-the-counter weight loss remedies or medications) within 3 months of screening\n* Are actively participating in, or have participated in a formal weight loss program within the last 3 months\n* Have a history of chronic use of drugs that directly affect gastrointestinal motility, including, but not limited to Reglan (metoclopramide) and chronic macrolide antibiotics\n* Have been treated with any anti-diabetic medications within 3 months of screening\n* Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to study start\n* Have had bariatric surgery\n* Have had an organ transplant","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"James Malone, MD","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Research Site","city":"Peoria","state":"Arizona","country":"United States","geoPoint":{"lat":33.5806,"lon":-112.23738}},{"facility":"Research Site","city":"Tucson","state":"Arizona","country":"United States","geoPoint":{"lat":32.22174,"lon":-110.92648}},{"facility":"Research Site","city":"Santa Ana","state":"California","country":"United States","geoPoint":{"lat":33.74557,"lon":-117.86783}},{"facility":"Research Site","city":"Indianapolis","state":"Indiana","country":"United States","geoPoint":{"lat":39.76838,"lon":-86.15804}},{"facility":"Research Site","city":"Topeka","state":"Kansas","country":"United States","geoPoint":{"lat":39.04833,"lon":-95.67804}},{"facility":"Research Site","city":"Wichita","state":"Kansas","country":"United States","geoPoint":{"lat":37.69224,"lon":-97.33754}},{"facility":"Research Site","city":"Baton Rouge","state":"Louisiana","country":"United States","geoPoint":{"lat":30.44332,"lon":-91.18747}},{"facility":"Research Site","city":"St Louis","state":"Missouri","country":"United States","geoPoint":{"lat":38.62727,"lon":-90.19789}},{"facility":"Research Site","city":"Oklahoma City","state":"Oklahoma","country":"United States","geoPoint":{"lat":35.46756,"lon":-97.51643}},{"facility":"Research Site","city":"Goose Creek","state":"South Carolina","country":"United States","geoPoint":{"lat":32.98101,"lon":-80.03259}},{"facility":"Research Site","city":"Spartanburg","state":"South Carolina","country":"United States","geoPoint":{"lat":34.94957,"lon":-81.93205}},{"facility":"Research Site","city":"Dallas","state":"Texas","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"Research Site","city":"San Antonio","state":"Texas","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Research Site","city":"Renton","state":"Washington","country":"United States","geoPoint":{"lat":47.48288,"lon":-122.21707}},{"facility":"Research Site","city":"Ponce","country":"Puerto Rico","geoPoint":{"lat":18.01031,"lon":-66.62398}},{"facility":"Research Site","city":"San Juan","country":"Puerto Rico","geoPoint":{"lat":18.46633,"lon":-66.10572}}]},"referencesModule":{"references":[{"pmid":"20332357","type":"DERIVED","citation":"Rosenstock J, Klaff LJ, Schwartz S, Northrup J, Holcombe JH, Wilhelm K, Trautmann M. Effects of exenatide and lifestyle modification on body weight and glucose tolerance in obese subjects with and without pre-diabetes. Diabetes Care. 2010 Jun;33(6):1173-5. doi: 10.2337/dc09-1203. Epub 2010 Mar 23."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Prior to randomization, subjects participated in a 1-week, single-blind placebo lead-in period.","recruitmentDetails":"Subject recruitment occurred between July 2007 and August 2007 at medical clinics in the United States.","groups":[{"id":"FG000","title":"Group A (Exenatide)","description":"exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP"},{"id":"FG001","title":"Group B (Placebo)","description":"placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"80"},{"groupId":"FG001","numSubjects":"83"}]},{"type":"Treatment Start-Baseline (Week 0)","achievements":[{"groupId":"FG000","numSubjects":"73"},{"groupId":"FG001","numSubjects":"79"}]},{"type":"Treatment Complete (Week 24)","achievements":[{"groupId":"FG000","numSubjects":"48"},{"groupId":"FG001","numSubjects":"54"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"COMPLETED = completion of treatment period (Week 24) plus follow-up visit 4 weeks later","numSubjects":"47"},{"groupId":"FG001","comment":"COMPLETED = completion of treatment period (Week 24) plus follow-up visit 4 weeks later","numSubjects":"49"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"34"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"Sponsor Decision","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Subject Decision","reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"17"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Group A (Exenatide)","description":"exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP"},{"id":"BG001","title":"Group B (Placebo)","description":"placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"73"},{"groupId":"BG001","value":"79"},{"groupId":"BG002","value":"152"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"47.01","spread":"10.95"},{"groupId":"BG001","value":"45.15","spread":"12.74"},{"groupId":"BG002","value":"46.04","spread":"11.91"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"58"},{"groupId":"BG001","value":"67"},{"groupId":"BG002","value":"125"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"27"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Body Weight","description":"Change in body weight from baseline after 24 weeks of treatment (i.e., body weight at week 24 minus body weight at week 0)","populationDescription":"Intent to Treat 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Ratio","description":"Waist-to-hip ratio at week 24 compared to waist-to-hip ratio at week 0 (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio equals waist circumference at given time point divided by hip circumference at given timepoint.","populationDescription":"Intent to Treat population","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Ratio","timeFrame":"24 weeks","groups":[{"id":"OG000","title":"Group A (Exenatide)","description":"exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP"},{"id":"OG001","title":"Group B (Placebo)","description":"placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"70"}]}],"classes":[{"title":"Baseline (Week 0)","categories":[{"measurements":[{"groupId":"OG000","value":"0.90","spread":"0.01"},{"groupId":"OG001","value":"0.90","spread":"0.01"}]}]},{"title":"Change at Endpoint (Week 24)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.001","spread":"0.01"},{"groupId":"OG001","value":"0.002","spread":"0.01"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Analysis pertains to change at endpoint (Week 24)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6766","statisticalMethod":"Mixed Model Repeated Measures ANCOVA","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Percentage of Patients Experiencing >=5% Weight Loss","description":"Percentage of exenatide and placebo treated patients experiencing \\>=5% weight loss after 24 weeks of treatment (i.e., \\[weight at week 0 minus weight at week 24\\] divided by weight at week 0 times 100% \\>=5%)","populationDescription":"Intent to Treat population; 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