{"protocolSection":{"identificationModule":{"nctId":"NCT04081337","orgStudyIdInfo":{"id":"17092"},"secondaryIdInfos":[{"id":"I8F-MC-GPGU","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study to Measure Energy Expenditure and Food Intake in Participants With Obesity Using Tirzepatide","officialTitle":"A Randomized, Placebo-Controlled, Parallel-Arm Study to Investigate the Effect of Once-Weekly Tirzepatide on Energy Expenditure and Food Intake in Obese Subjects"},"statusModule":{"statusVerifiedDate":"2023-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-07-09","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-05-26","type":"ACTUAL"},"completionDateStruct":{"date":"2022-05-26","type":"ACTUAL"},"studyFirstSubmitDate":"2019-09-05","studyFirstSubmitQcDate":"2019-09-05","studyFirstPostDateStruct":{"date":"2019-09-09","type":"ACTUAL"},"resultsFirstSubmitDate":"2023-05-26","resultsFirstSubmitQcDate":"2023-05-26","resultsFirstPostDateStruct":{"date":"2024-02-08","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-05-26","lastUpdatePostDateStruct":{"date":"2024-02-08","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This is a study of tirzepatide in participants with obesity. The main purpose is to learn more about how tirzepatide affects the number of calories participants burn and the amount of food they eat. The study lasted for 28 weeks and will include about 21 visits to the study center."},"conditionsModule":{"conditions":["Obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":55,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants received placebo once weekly (QW) by Subcutaneous (SC) injection.","interventionNames":["Drug: Placebo"]},{"label":"15 Milligram (mg) Tirzepatide","type":"EXPERIMENTAL","description":"Participants received 15 mg of tirzepatide QW by SC injection.","interventionNames":["Drug: Tirzepatide"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Administered SC","armGroupLabels":["15 Milligram (mg) Tirzepatide"],"otherNames":["LY3298176"]},{"type":"DRUG","name":"Placebo","description":"Administered SC","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline to Week 18 in Sleep Metabolic Rate (SMR)","description":"SMR was measured using whole-room indirect calorimetry (respiratory chamber). Change from Baseline to Week 18 in SMR was evaluated. Least square (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline, Treatment, Change from Baseline to Week 18 in Fat-Free Mass, Change from baseline to Week 18 in Fat Mass and Random Error as variables.","timeFrame":"Baseline, Week 18"}],"secondaryOutcomes":[{"measure":"Change From Baseline to Week 18 in Food Intake During Ad Libitum Meal","description":"Ad libitum lunch and dinner were provided. The sum of the caloric breakdown (carbohydrates, protein, and fats) was calculated from the respective nutritional information of the food items. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","timeFrame":"Baseline, Week 18"},{"measure":"Change From Baseline to Week 18 in 24-hour Energy Expenditure (EE)","description":"24 hour energy expenditure was measured in a respiratory chamber. LS mean was determined by ANCOVA model with Baseline, Treatment, Change from Baseline to Week 18 in Fat-Free Mass, Change from baseline to Week 18 in Fat Mass and Random Error as variables.","timeFrame":"Baseline, Week 18"},{"measure":"Change From Baseline to Week 18 in 24 Hour Respiratory Quotient (RQ)","description":"Respiratory quotient was calculated as the ratio of carbon dioxide production to oxygen consumption as measured in a metabolic chamber for 24 continuous hours. Ratio of total carbon dioxide production (VCO2)/total oxygen consumption (VO2), from baseline to Week 18 was evaluated. 24-hour RQ = total VCO2 \\[Liter/24hour\\] / total VO2 \\[Liter/24hour\\]. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","timeFrame":"Baseline, Week 18"},{"measure":"Change From Baseline to Week 18 in Sleep RQ","description":"Sleep RQ is defined as the ratio of VCO2 to VO2 during sleep time points. Change from baseline to Week 18 in sleep RQ is presented. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","timeFrame":"Baseline, Week 18"},{"measure":"Change From Baseline to Week 18 in Duration of Periods With RQ<0.80","description":"RQ\\<0.80 is defined as the cut point for high lipid oxidation of RQ; lipid oxidation will be calculated and corrected for protein oxidation; the total number of minutes with RQ \\<0.80, termed \"lipid oxidation duration,\" during each 23-hour measurement period will be recorded; protein oxidation will be determined from urine nitrogen that will be collected during 2 periods for each calorimeter day. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","timeFrame":"Baseline, Week 18"},{"measure":"Change From Baseline to Week 18 in Fat, Protein, and Carbohydrate Oxidation","description":"Change from Baseline to Week 18 in Fat, Protein, and Carbohydrate Oxidation is presented.\n\n* Protein Oxidation = 6.25\\*\\[urinary nitrogen\\]\n* Fat Oxidation = 1.689\\*\\[total oxygen consumption (VO2)\\] - 1.689\\*\\[total carbon dioxide production (VCO2)\\] - 0.324\\*\\[protein oxidation\\]\n* Carbohydrate Oxidation = 4.113\\*\\[VCO2\\] - 2.907\\*\\[VO2\\] - 0.375\\*\\[protein oxidation\\].\n\nAdjusted oxidation is calculated using the formula, Adjusted oxidation rate (g/day) = oxidation rate (g/day) / 24-hour Energy Expenditure) x 1000 (kcal/day).\n\nLS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","timeFrame":"Baseline, Week 18"},{"measure":"Change From Baseline to Week 18 in Body Weight (BW)","description":"Change from baseline in BW through Week 18 in participants were presented. LS mean was determined by mixed measures repeated model (MMRM) model with Baseline, Treatment, Time, Treatment\\*Time, Participant and Random Error as variables.","timeFrame":"Baseline, Week 18"},{"measure":"Change From Baseline to Week 18 in Body Fat-Free Mass","description":"Change from baseline to Week 18 in body fat free mass is presented. Body fat free mass was measured using dual energy X-ray absorptiometry (DXA) measurements. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","timeFrame":"Baseline, Week 18"},{"measure":"Change From Baseline to Week 18 in Body Fat Mass","description":"Change from baseline to Week 18 in body fat mass is presented. Body fat mass was measured using DXA measurements. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","timeFrame":"Baseline, Week 18"},{"measure":"Change From Baseline to Week 18 in Percentage of Body Fat Mass","description":"The total body fat mass was measured in kilograms (kg) using DXA scanning. Change from baseline to week 18 in percentage of body fat mass is reported. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","timeFrame":"Baseline, Week 18"},{"measure":"Change From Baseline to Week 18 in Lipid Metabolism Parameters","description":"Change in Lipid Metabolism Parameters from baseline (week 0) to week 18 is evaluated. Triglyceride, Very low density lipoprotein (VLDL), High density lipoprotein (HDL) cholesterol and free fatty acids values were reported. Results below presents Area under the Curve (AUC) during standardized mixed-meal tolerance test (sMMTT). LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","timeFrame":"Baseline, Week 18"},{"measure":"Change From Baseline to Week 18 in Fasting Insulin Resistance","description":"Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) is a test that uses a simultaneous fasting blood glucose test and fasting insulin test to accurately estimate the degree of insulin resistance (IR) and β-cell function (the cells of the pancreas that produce insulin).\n\nHOMA-IR= \\[Fasting glucose (mmol/L) x (fasting insulin (picomoles per liter {pmol/L})/6)\\] / 22.5. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","timeFrame":"Baseline, Week 18 during standardized mixed meal tolerance test"},{"measure":"Change From Baseline to Week 18 in Postprandial Insulin Sensitivity","description":"Insulin sensitivity was measured from insulin and glucose levels obtained following standard meal challenge using a modification of the Matsuda index. This was calculated based on data obtained from a 75 g oral glucose tolerance test, as follows: 10,000 divided by the square root of {(fasting glucose X fasting insulin) (total area under the glucose response curve (AUC) 0-4hr)) X total insulin AUC(0-4hr )}. A Matsuda index of \\<2.5 indicates whole body insulin resistance. A lower Matsuda Index indicates the worst disease state. An increase in the Matsuda Index indicates an improvement in insulin sensitivity (best). A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening. Stumvoll and oral glucose insulin sensitivity indexes were also used for measuring the insulin Sensitivity. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","timeFrame":"Baseline, Week 18"},{"measure":"Change From Baseline to Week 18 in Postmeal Total Glucose AUC During sMMTT","description":"Total AUC from time zero to 4 hours after start of the meal \\[AUC0-4 hours\\]) during sMMTT was evaluated. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","timeFrame":"Baseline, Week 18"},{"measure":"Change From Baseline to Week 18 in Hemoglobin A1c (HbA1c)","description":"HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean was determined by ANCOVA model with Baseline, Treatment, Time, Treatment\\*Time, Participant and Random Error as variables.","timeFrame":"Baseline, Week 18"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have body mass index of 30 to 45 kilograms per square meter (kg/m²), inclusive\n* Have a stable body weight in the past 1 month prior to screening\n* Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff\n\nExclusion Criteria:\n\n* Have undergone gastric bypass or bariatric surgery\n* Have a diagnosis of type 2 diabetes\n* Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data\n* Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening\n* Have any lifetime history of a suicide attempt\n* Patient Health Questionnaire-9 (PHQ-9) score of 15 or more at screening\n* Positive responses to selected items on the Columbia Suicide Severity Rating Scale (C-SSRS)","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"60 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Pennington Biomedical Research Center","city":"Baton Rouge","state":"Louisiana","zip":"70808","country":"United States","geoPoint":{"lat":30.44332,"lon":-91.18747}}]},"referencesModule":{"seeAlsoLinks":[{"label":"A Study to Measure Food and Calorie Consumption in Very Overweight Participants Using Tirzepatide","url":"https://trials.lillytrialguide.com/en-US/trial/1nfPN3HbtLj7FPbvr6zfwo"}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Placebo","description":"Participants received placebo once weekly (QW) by Subcutaneous (SC) injection."},{"id":"FG001","title":"15 Milligram (mg) Tirzepatide","description":"Participants received 15 mg of tirzepatide QW by SC injection."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"27"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"27"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"24"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized participants who received at least one dose of study drug.","groups":[{"id":"BG000","title":"Placebo","description":"Participants received placebo QW by SC injection."},{"id":"BG001","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide QW by SC injection."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"27"},{"groupId":"BG002","value":"55"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"48.1","spread":"10.7"},{"groupId":"BG001","value":"45.5","spread":"9.8"},{"groupId":"BG002","value":"46.8","spread":"10.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"46"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"9"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"23"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"29"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"27"},{"groupId":"BG002","value":"55"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline to Week 18 in Sleep Metabolic Rate (SMR)","description":"SMR was measured using whole-room indirect calorimetry (respiratory chamber). Change from Baseline to Week 18 in SMR was evaluated. Least square (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline, Treatment, Change from Baseline to Week 18 in Fat-Free Mass, Change from baseline to Week 18 in Fat Mass and Random Error as variables.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable data for SMR.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilocalories per day (kcal/day)","timeFrame":"Baseline, Week 18","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo QW by SC injection."},{"id":"OG001","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide QW by SC injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"21"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-154.36","spread":"19.69"},{"groupId":"OG001","value":"-134.68","spread":"21.62"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.5733","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"19.68","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-50.36","ciUpperLimit":"89.72"}]},{"type":"SECONDARY","title":"Change From Baseline to Week 18 in Food Intake During Ad Libitum Meal","description":"Ad libitum lunch and dinner were provided. The sum of the caloric breakdown (carbohydrates, protein, and fats) was calculated from the respective nutritional information of the food items. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable data for food Intake during ad libitum meal.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilocalories (kcal)","timeFrame":"Baseline, Week 18","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo QW by SC injection."},{"id":"OG001","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide QW by SC injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-58.57","spread":"82.29"},{"groupId":"OG001","value":"-914.51","spread":"82.29"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-855.94","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1090.87","ciUpperLimit":"-621.02"}]},{"type":"SECONDARY","title":"Change From Baseline to Week 18 in 24-hour Energy Expenditure (EE)","description":"24 hour energy expenditure was measured in a respiratory chamber. LS mean was determined by ANCOVA model with Baseline, Treatment, Change from Baseline to Week 18 in Fat-Free Mass, Change from baseline to Week 18 in Fat Mass and Random Error as variables.","populationDescription":"All randomized participants who received at least one dose of study drug and who had evaluable data for 24-hour EE.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kcal/day","timeFrame":"Baseline, Week 18","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo QW by SC injection."},{"id":"OG001","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide QW by SC injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"21"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-296.85","spread":"27.67"},{"groupId":"OG001","value":"-300.07","spread":"30.44"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.9481","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-3.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-102.65","ciUpperLimit":"96.20"}]},{"type":"SECONDARY","title":"Change From Baseline to Week 18 in 24 Hour Respiratory Quotient (RQ)","description":"Respiratory quotient was calculated as the ratio of carbon dioxide production to oxygen consumption as measured in a metabolic chamber for 24 continuous hours. Ratio of total carbon dioxide production (VCO2)/total oxygen consumption (VO2), from baseline to Week 18 was evaluated. 24-hour RQ = total VCO2 \\[Liter/24hour\\] / total VO2 \\[Liter/24hour\\]. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","populationDescription":"All randomized participants who received at least one dose of study drug and who had evaluable data for 24-hour RQ.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Ratio","timeFrame":"Baseline, Week 18","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo QW by SC injection."},{"id":"OG001","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide QW by SC injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"21"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.005","spread":"0.005"},{"groupId":"OG001","value":"-0.030","spread":"0.006"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.034","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.051","ciUpperLimit":"-0.018"}]},{"type":"SECONDARY","title":"Change From Baseline to Week 18 in Sleep RQ","description":"Sleep RQ is defined as the ratio of VCO2 to VO2 during sleep time points. Change from baseline to Week 18 in sleep RQ is presented. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","populationDescription":"All randomized participants who received at least one dose of study drug and who had evaluable data for sleep RQ.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"ratio","timeFrame":"Baseline, Week 18","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo QW by SC injection."},{"id":"OG001","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide QW by SC injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"21"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.001","spread":"0.006"},{"groupId":"OG001","value":"-0,028","spread":"0.006"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0031","statisticalMethod":"ANCOVA","paramType":"LS Mean difference","paramValue":"-0.028","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.045","ciUpperLimit":"-0.010"}]},{"type":"SECONDARY","title":"Change From Baseline to Week 18 in Duration of Periods With RQ<0.80","description":"RQ\\<0.80 is defined as the cut point for high lipid oxidation of RQ; lipid oxidation will be calculated and corrected for protein oxidation; the total number of minutes with RQ \\<0.80, termed \"lipid oxidation duration,\" during each 23-hour measurement period will be recorded; protein oxidation will be determined from urine nitrogen that will be collected during 2 periods for each calorimeter day. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","populationDescription":"All randomized participants who received at least one dose of study drug and who had evaluable data for duration of periods with RQ\\<0.80.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"minute","timeFrame":"Baseline, Week 18","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo QW by SC injection."},{"id":"OG001","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide QW by SC injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"21"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.55","spread":"43.97"},{"groupId":"OG001","value":"254.44","spread":"47.14"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0004","statisticalMethod":"ANCOVA","paramType":"LS Mean difference","paramValue":"251.89","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"119.09","ciUpperLimit":"384.69"}]},{"type":"SECONDARY","title":"Change From Baseline to Week 18 in Fat, Protein, and Carbohydrate Oxidation","description":"Change from Baseline to Week 18 in Fat, Protein, and Carbohydrate Oxidation is presented.\n\n* Protein Oxidation = 6.25\\*\\[urinary nitrogen\\]\n* Fat Oxidation = 1.689\\*\\[total oxygen consumption (VO2)\\] - 1.689\\*\\[total carbon dioxide production (VCO2)\\] - 0.324\\*\\[protein oxidation\\]\n* Carbohydrate Oxidation = 4.113\\*\\[VCO2\\] - 2.907\\*\\[VO2\\] - 0.375\\*\\[protein oxidation\\].\n\nAdjusted oxidation is calculated using the formula, Adjusted oxidation rate (g/day) = oxidation rate (g/day) / 24-hour Energy Expenditure) x 1000 (kcal/day).\n\nLS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","populationDescription":"All randomized participants who received at least one dose of study drug and who had evaluable data for fat, protein, and carbohydrate oxidation.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"gram/day","timeFrame":"Baseline, Week 18","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo QW by SC injection."},{"id":"OG001","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide QW by SC injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"21"}]}],"classes":[{"title":"Adjusted protein oxidation","categories":[{"measurements":[{"groupId":"OG000","value":"-0.14","spread":"1.23"},{"groupId":"OG001","value":"-7.00","spread":"1.32"}]}]},{"title":"Adjusted fat oxidation","categories":[{"measurements":[{"groupId":"OG000","value":"-1.64","spread":"2.15"},{"groupId":"OG001","value":"12.83","spread":"2.30"}]}]},{"title":"Adjusted carbohydrate oxidation","categories":[{"measurements":[{"groupId":"OG000","value":"4.23","spread":"4.24"},{"groupId":"OG001","value":"-22.42","spread":"4.54"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"For Adjusted protein oxidation","nonInferiorityType":"SUPERIORITY","pValue":"0.0005","statisticalMethod":"ANCOVA","paramType":"LS Mean difference","paramValue":"-6.87","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-10.51","ciUpperLimit":"-3.22"},{"groupIds":["OG000","OG001"],"groupDescription":"For Adjusted fat oxidation","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"LS Mean difference","paramValue":"14.48","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"8.02","ciUpperLimit":"20.93"},{"groupIds":["OG000","OG001"],"groupDescription":"Adjusted carbohydrate oxidation","nonInferiorityType":"SUPERIORITY","pValue":"0.0001","statisticalMethod":"ANCOVA","paramType":"LS Mean difference","paramValue":"-26.64","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-39.46","ciUpperLimit":"-13.83"}]},{"type":"SECONDARY","title":"Change From Baseline to Week 18 in Body Weight (BW)","description":"Change from baseline in BW through Week 18 in participants were presented. LS mean was determined by mixed measures repeated model (MMRM) model with Baseline, Treatment, Time, Treatment\\*Time, Participant and Random Error as variables.","populationDescription":"All randomized participants who received at least one dose of study drug and who had evaluable data for body weight.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilogram (kg)","timeFrame":"Baseline, Week 18","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo QW by SC injection."},{"id":"OG001","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide QW by SC injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-8.26","spread":"0.90"},{"groupId":"OG001","value":"-16.73","spread":"0.92"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference","paramValue":"-8.47","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-11.04","ciUpperLimit":"-5.90"}]},{"type":"SECONDARY","title":"Change From Baseline to Week 18 in Body Fat-Free Mass","description":"Change from baseline to Week 18 in body fat free mass is presented. Body fat free mass was measured using dual energy X-ray absorptiometry (DXA) measurements. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","populationDescription":"All randomized participants who received at least one dose of study drug and who had evaluable data for body fat-free mass.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kg","timeFrame":"Baseline, Week 18","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo QW by SC injection."},{"id":"OG001","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide QW by SC injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.64","spread":"0.36"},{"groupId":"OG001","value":"-5.73","spread":"0.36"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference","paramValue":"-4.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.12","ciUpperLimit":"-3.05"}]},{"type":"SECONDARY","title":"Change From Baseline to Week 18 in Body Fat Mass","description":"Change from baseline to Week 18 in body fat mass is presented. Body fat mass was measured using DXA measurements. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","populationDescription":"All randomized participants who received at least one dose of study drug and who had evaluable data for body fat mass.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kg","timeFrame":"Baseline, Week 18","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo QW by SC injection."},{"id":"OG001","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide QW by SC injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.75","spread":"0.65"},{"groupId":"OG001","value":"-11.83","spread":"0.65"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"LS Mean difference","paramValue":"-5.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.93","ciUpperLimit":"-3.22"}]},{"type":"SECONDARY","title":"Change From Baseline to Week 18 in Percentage of Body Fat Mass","description":"The total body fat mass was measured in kilograms (kg) using DXA scanning. Change from baseline to week 18 in percentage of body fat mass is reported. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","populationDescription":"All randomized participants who received at least one dose of study drug and who had evaluable data for percentage of body fat mass.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage","timeFrame":"Baseline, Week 18","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo QW by SC injection."},{"id":"OG001","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide QW by SC injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.12","spread":"0.36"},{"groupId":"OG001","value":"-4.26","spread":"0.36"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0304","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-1.14","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.16","ciUpperLimit":"-0.11"}]},{"type":"SECONDARY","title":"Change From Baseline to Week 18 in Lipid Metabolism Parameters","description":"Change in Lipid Metabolism Parameters from baseline (week 0) to week 18 is evaluated. Triglyceride, Very low density lipoprotein (VLDL), High density lipoprotein (HDL) cholesterol and free fatty acids values were reported. Results below presents Area under the Curve (AUC) during standardized mixed-meal tolerance test (sMMTT). LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","populationDescription":"All randomized participants who received at least one dose of study drug and who had evaluable data for lipid metabolism parameters.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimole hour per liter (mmol.h/L)","timeFrame":"Baseline, Week 18","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo QW by SC injection."},{"id":"OG001","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide QW by SC injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"23"}]}],"classes":[{"title":"Triglyceride","categories":[{"measurements":[{"groupId":"OG000","value":"-0.69","spread":"0.27"},{"groupId":"OG001","value":"-2.52","spread":"0.27"}]}]},{"title":"VLDL cholesterol","categories":[{"measurements":[{"groupId":"OG000","value":"-0.32","spread":"0.12"},{"groupId":"OG001","value":"-1.16","spread":"0.12"}]}]},{"title":"HDL cholesterol","categories":[{"measurements":[{"groupId":"OG000","value":"0.20","spread":"0.18"},{"groupId":"OG001","value":"-0.33","spread":"0.18"}]}]},{"title":"Free fatty acid","categories":[{"measurements":[{"groupId":"OG000","value":"-0.09","spread":"0.08"},{"groupId":"OG001","value":"0.35","spread":"0.08"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"For Triglyceride","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"LS Mean difference","paramValue":"-1.83","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.60","ciUpperLimit":"-1.06"},{"groupIds":["OG000","OG001"],"groupDescription":"For VLDL","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"LS Mean difference","paramValue":"-0.84","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.19","ciUpperLimit":"-0.48"},{"groupIds":["OG000","OG001"],"groupDescription":"For HDL","nonInferiorityType":"SUPERIORITY","pValue":"0.0436","statisticalMethod":"ANCOVA","paramType":"LS Mean difference","paramValue":"-0.53","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.05","ciUpperLimit":"-0.02"},{"groupIds":["OG000","OG001"],"groupDescription":"For Free fatty acid","nonInferiorityType":"SUPERIORITY","pValue":"0.0002","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"0.45","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.23","ciUpperLimit":"0.66"}]},{"type":"SECONDARY","title":"Change From Baseline to Week 18 in Fasting Insulin Resistance","description":"Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) is a test that uses a simultaneous fasting blood glucose test and fasting insulin test to accurately estimate the degree of insulin resistance (IR) and β-cell function (the cells of the pancreas that produce insulin).\n\nHOMA-IR= \\[Fasting glucose (mmol/L) x (fasting insulin (picomoles per liter {pmol/L})/6)\\] / 22.5. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","populationDescription":"All randomized participants who received at least one dose of study drug and who had evaluable HOMA-IR data.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"index","timeFrame":"Baseline, Week 18 during standardized mixed meal tolerance test","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo QW by SC injection."},{"id":"OG001","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide QW by SC injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"19"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.37","spread":"0.12"},{"groupId":"OG001","value":"-0.34","spread":"0.14"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.8762","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"0.03","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.34","ciUpperLimit":"0.40"}]},{"type":"SECONDARY","title":"Change From Baseline to Week 18 in Postprandial Insulin Sensitivity","description":"Insulin sensitivity was measured from insulin and glucose levels obtained following standard meal challenge using a modification of the Matsuda index. This was calculated based on data obtained from a 75 g oral glucose tolerance test, as follows: 10,000 divided by the square root of {(fasting glucose X fasting insulin) (total area under the glucose response curve (AUC) 0-4hr)) X total insulin AUC(0-4hr )}. A Matsuda index of \\<2.5 indicates whole body insulin resistance. A lower Matsuda Index indicates the worst disease state. An increase in the Matsuda Index indicates an improvement in insulin sensitivity (best). A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening. Stumvoll and oral glucose insulin sensitivity indexes were also used for measuring the insulin Sensitivity. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable data for matsuda index.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"index","timeFrame":"Baseline, Week 18","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo QW by SC injection."},{"id":"OG001","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide QW by SC injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"23"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.43","spread":"0.94"},{"groupId":"OG001","value":"4.92","spread":"0.94"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0126","statisticalMethod":"ANCOVA","paramType":"LS Mean difference","paramValue":"3.49","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.79","ciUpperLimit":"6.19"}]},{"type":"SECONDARY","title":"Change From Baseline to Week 18 in Postmeal Total Glucose AUC During sMMTT","description":"Total AUC from time zero to 4 hours after start of the meal \\[AUC0-4 hours\\]) during sMMTT was evaluated. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable data for postmeal total glucose AUC during sMMTT.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimolar.hour per liter (mmol.h/L)","timeFrame":"Baseline, Week 18","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo QW by SC injection."},{"id":"OG001","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide QW by SC injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"23"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.73","spread":"0.38"},{"groupId":"OG001","value":"-3.00","spread":"0.38"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0222","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-1.26","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.34","ciUpperLimit":"-0.19"}]},{"type":"SECONDARY","title":"Change From Baseline to Week 18 in Hemoglobin A1c (HbA1c)","description":"HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean was determined by ANCOVA model with Baseline, Treatment, Time, Treatment\\*Time, Participant and Random Error as variables.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable data for HbA1c.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of glycosylated hemoglobin","timeFrame":"Baseline, Week 18","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo QW by SC injection."},{"id":"OG001","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide QW by SC injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.04","spread":"0.04"},{"groupId":"OG001","value":"-0.40","spread":"0.04"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"LS Mean difference","paramValue":"-0.36","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.48","ciUpperLimit":"-0.23"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Baseline Through End of Safety Follow-up (Up to 22 Weeks)","description":"All randomized participants who received at least one dose of study drug, regardless of whether they completed all protocol requirements. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.","eventGroups":[{"id":"EG000","title":"Placebo","description":"Participants received placebo once weekly by SC injection.","deathsNumAffected":0,"deathsNumAtRisk":28,"seriousNumAffected":0,"seriousNumAtRisk":28,"otherNumAffected":19,"otherNumAtRisk":28},{"id":"EG001","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide once weekly by subcutaneous injection.","deathsNumAffected":0,"deathsNumAtRisk":27,"seriousNumAffected":1,"seriousNumAtRisk":27,"otherNumAffected":22,"otherNumAtRisk":27}],"seriousEvents":[{"term":"Pancreatitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":28},{"groupId":"EG001","numEvents":31,"numAffected":10,"numAtRisk":27}]},{"term":"Pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":28},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":27}]},{"term":"Corona virus infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":28},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":27}]},{"term":"Sinusitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 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22.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":28},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":27}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"GT60","restrictiveAgreement":true},"pointOfContact":{"title":"Chief Medical Officer","organization":"Eli Lilly and Company","email":"ClinicalTrials.gov@lilly.com","phone":"800-545-5979"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2021-08-02","uploadDate":"2023-05-24T13:05","filename":"Prot_000.pdf","size":5428558},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis 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Proteins"},{"id":"D011506","term":"Proteins"},{"id":"D000602","term":"Amino Acids, Peptides, and Proteins"},{"id":"D011964","term":"Receptors, Gastrointestinal Hormone"},{"id":"D018000","term":"Receptors, Peptide"}]}},"hasResults":true}