{"protocolSection":{"identificationModule":{"nctId":"NCT04889157","orgStudyIdInfo":{"id":"C3421028"},"organization":{"fullName":"Pfizer","class":"INDUSTRY"},"briefTitle":"A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PF-06882961 in Chinese Adults With Type 2 Diabetes Mellitus","officialTitle":"AN 8-WEEK, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED PHASE 1 STUDY TO EVALUATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND TOLERABILITY OF PF-06882961 IN CHINESE ADULTS WITH TYPE 2 DIABETES MELLITUS"},"statusModule":{"statusVerifiedDate":"2024-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-07-07","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-02-17","type":"ACTUAL"},"completionDateStruct":{"date":"2022-02-17","type":"ACTUAL"},"studyFirstSubmitDate":"2021-05-12","studyFirstSubmitQcDate":"2021-05-12","studyFirstPostDateStruct":{"date":"2021-05-17","type":"ACTUAL"},"resultsFirstSubmitDate":"2023-01-17","resultsFirstSubmitQcDate":"2024-06-18","resultsFirstPostDateStruct":{"date":"2024-10-01","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-06-18","lastUpdatePostDateStruct":{"date":"2024-10-01","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Pfizer","class":"INDUSTRY"}},"oversightModule":{"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"This is a Phase 1, randomized, double-blind (sponsor open), placebo controlled study in adult Chinese participants with T2DM who are receiving metformin as background antihyperglycemic medication."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":20,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"PF-06882961","type":"EXPERIMENTAL","description":"Participants will be titrated up to 6 weeks of the 8-week dosing duration to reach desired dose level 120 mg","interventionNames":["Drug: PF-06882961"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"PF-06882961","description":"Participants will be administered active doses, taking 3 tablets twice daily (BID) for 8 weeks except Day 1 (QD)","armGroupLabels":["PF-06882961"]},{"type":"DRUG","name":"Placebo","description":"3 matching placebo tablets taken twice daily (BID) except Day 1 (QD)","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC24) of PF-06882961 10 mg Single Dose on Day 1","description":"AUC24 is the area under the plasma concentration-time profile from time zero to the time 24 hours. The planned analysis was not considered reliable by the sponsor.","timeFrame":"Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1"},{"measure":"Maximum Observed Concentration (Cmax) of PF-06882961 10 mg Single Dose on Day 1","description":"Cmax is the maximum observed plasma concentration over 24 hours. The planned analysis was not considered reliable by the sponsor.","timeFrame":"Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1"},{"measure":"AUC24 of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961","description":"AUC24 was measured on Day 21, 35, and 56 for dose 40 mg BID, 80 mg BID, and 120 mg BID, respectively. The planned analysis was not considered reliable by the sponsor.","timeFrame":"Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 21 (40 mg BID), 35 (80 mg BID), and 56 (120 mg BID)"},{"measure":"Maximum Observed Concentration, Steady State (Cmax,ss) of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961","description":"Cmax,ss was measured on Day 21, 35, and 56 for dose 40 mg BID, 80 mg BID, and 120 mg BID, respectively. The planned analysis was not considered reliable by the sponsor.","timeFrame":"Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 21 (40 mg BID), 35 (80 mg BID), and 56 (120 mg BID)"}],"secondaryOutcomes":[{"measure":"Number of Participants With Clinically Significant Change From Baseline in Vital Signs","description":"Supine blood pressure and pulse rate were measured with the participant's arm supported at the level of the heart and recorded to the nearest mmHg after approximately 5 minutes of rest and maximum absolute values and maximum changes from baseline from time-matched baseline were evaluated at the investigator's discretion.","timeFrame":"Baseline up to 14 days after last dose (Day 70)"},{"measure":"Number of Participants With Abnormal Electrocardiogram (ECG)","description":"Standard 12-lead ECGs utilizing limb leads were collected using an ECG machine that automatically calculated the heart rate and measures PR, QT, and QT interval corrected for heart rate (QTc) and QRS complex.","timeFrame":"Baseline up to 14 days after last dose (Day 70)"},{"measure":"Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)","description":"An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event was defined as any untoward medical occurrence that,at any dose:resulted in death;was life-threatening;required inpatient hospitalization or prolongation of existing hospitalization;resulted in persistent disability/incapacity; was a congenital anomaly/birth defect;or other serious situations such as important medical events. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.","timeFrame":"Baseline up to 35 days after last dose (Day 91)"},{"measure":"Number of Participants With Laboratory Abnormalities","description":"Laboratory tests (including hematological, clinical chemistry, urinalysis tests) were reported and abnormality was determined at the investigator's discretion.","timeFrame":"Baseline up to 14 days after last dose (Day 70)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Patients with T2DM who are taking metformin monotherapy as their only antihyperglycemic treatment\n* HbA1c greater than or equal to 7% and less than or equal to 10.5%\n* Total body weight \\>50 kg (110 lb) with BMI of 22.5 to 45.4 kg/m\\^2\n\nExclusion Criteria:\n\n* Any condition possibly affecting drug absorption\n* Diagnosis of Type 1 diabetes mellitus or secondary forms of diabetes\n* History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of Screening\n* Any malignancy not considered cured\n* Personal or family history of MTC or MEN2, or participants with suspected MTC\n* Acute pancreatitis or history of chronic pancreatitis\n* Acute gallbladder disease\n* Known history of HIV, hepatitis B, hepatitis C or syphilis, or positive testing of them\n* Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)\n* Clinically relevant ECG abnormalities\n* Positive urine drug test\n* Clinical relevant laboratory tests abnormalities","healthyVolunteers":false,"sex":"ALL","minimumAge":"20 Years","maximumAge":"60 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Pfizer CT.gov Call Center","affiliation":"Pfizer","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Peking University Third Hospital","city":"Beijing","zip":"100089","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}}]},"referencesModule":{"seeAlsoLinks":[{"label":"To obtain contact information for a study center near you, click here.","url":"https://pmiform.com/clinical-trial-info-request?StudyID=C3421028"}]},"ipdSharingStatementModule":{"ipdSharing":"NO","description":"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Placebo","description":"Participants received placebo BID (except QD in the morning on Day 1) from Days 1-56."},{"id":"FG001","title":"PF-06882961 BID","description":"Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56."}],"periods":[{"title":"BLINDED TREATMENT","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"15"}]},{"type":"Discontinued","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"15"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"Follow-Up","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"15"}]},{"type":"Received Treatment","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"15"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"15"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All enrolled participants who were randomized and received at least one dose of study treatment.","groups":[{"id":"BG000","title":"Placebo","description":"Participants received placebo BID (except QD in the morning on Day 1) from Days 1-56."},{"id":"BG001","title":"PF-06882961 BID","description":"Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"20"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"title":"Mean (SD)","categories":[{"measurements":[{"groupId":"BG000","value":"50","spread":"4.64"},{"groupId":"BG001","value":"49.5","spread":"7.22"},{"groupId":"BG002","value":"49.6","spread":"6.56"}]}]}]},{"title":"Age, Customized","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"20-44 Years","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"5"}]}]},{"title":"45-60 Years","categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"15"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"9"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"11"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"Asian","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"20"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"Not Hispanic or Latino","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"20"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC24) of PF-06882961 10 mg Single Dose on Day 1","description":"AUC24 is the area under the plasma concentration-time profile from time zero to the time 24 hours. The planned analysis was not considered reliable by the sponsor.","populationDescription":"All participants randomized and treated with PF-06882961 who had at least 1 plasma concentration value collected.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram*hour per milliter (ng*hr/mL)","timeFrame":"Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1","groups":[{"id":"OG000","title":"PF-06882961 10 mg Single Dose","description":"Participants received single dose of PF-06882961 on Day 1."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"287.4","spread":"52"}]}]}]},{"type":"PRIMARY","title":"Maximum Observed Concentration (Cmax) of PF-06882961 10 mg Single Dose on Day 1","description":"Cmax is the maximum observed plasma concentration over 24 hours. The planned analysis was not considered reliable by the sponsor.","populationDescription":"All participants randomized and treated with PF-06882961 who had at least 1 plasma concentration value collected.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram per milliter (ng/mL)","timeFrame":"Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1","groups":[{"id":"OG000","title":"PF-06882961 BID","description":"Participants received single dose of PF-06882961 on Day 1."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"37.37","spread":"39"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Clinically Significant Change From Baseline in Vital Signs","description":"Supine blood pressure and pulse rate were measured with the participant's arm supported at the level of the heart and recorded to the nearest mmHg after approximately 5 minutes of rest and maximum absolute values and maximum changes from baseline from time-matched baseline were evaluated at the investigator's discretion.","populationDescription":"All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"timeFrame":"Baseline up to 14 days after last dose (Day 70)","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo BID (except QD in the morning on Day 1) from Days 1-56."},{"id":"OG001","title":"PF-06882961 BID","description":"Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"15"}]}],"classes":[{"title":"Supine systolic blood pressure (mmHg) change >=30 mm Hg increase","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"}]}]},{"title":"Supine systolic blood pressure (mmHg) change >=30 mm Hg decrease","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]}]},{"title":"Supine diastolic blood pressure (mmHg) change >=20 mm Hg increase","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"6"}]}]},{"title":"Supine diastolic blood pressure (mmHg) change >=20 mm Hg decrease","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]},{"title":"Supine pulse rate (beats per minute [bpm]) value >120 bpm","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Abnormal Electrocardiogram (ECG)","description":"Standard 12-lead ECGs utilizing limb leads were collected using an ECG machine that automatically calculated the heart rate and measures PR, QT, and QT interval corrected for heart rate (QTc) and QRS complex.","populationDescription":"All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"timeFrame":"Baseline up to 14 days after last dose (Day 70)","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo BID (except QD in the morning on Day 1) from Days 1-56."},{"id":"OG001","title":"PF-06882961 BID","description":"Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"15"}]}],"classes":[{"title":"PR interval not otherwise specified (msec) %change >=50%","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]},{"title":"QTcF not otherwise specified (msec) 450 < Value <=480","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)","description":"An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event was defined as any untoward medical occurrence that,at any dose:resulted in death;was life-threatening;required inpatient hospitalization or prolongation of existing hospitalization;resulted in persistent disability/incapacity; was a congenital anomaly/birth defect;or other serious situations such as important medical events. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.","populationDescription":"All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"timeFrame":"Baseline up to 35 days after last dose (Day 91)","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo BID (except QD in the morning on Day 1) from Days 1-56."},{"id":"OG001","title":"PF-06882961 BID","description":"Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"15"}]}],"classes":[{"title":"Participants with non-serious AEs","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"14"}]}]},{"title":"Participants with serious adverse events","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Laboratory Abnormalities","description":"Laboratory tests (including hematological, clinical chemistry, urinalysis tests) were reported and abnormality was determined at the investigator's discretion.","populationDescription":"All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"timeFrame":"Baseline up to 14 days after last dose (Day 70)","groups":[{"id":"OG000","title":"Placebo","description":"Participants received placebo BID (except QD in the morning on Day 1) from Days 1-56."},{"id":"OG001","title":"PF-06882961 BID","description":"Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"15"}]}],"classes":[{"title":"Hematology - Neutrophils (10^3/mm3) >1.2xupper limit of norma (ULN)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]},{"title":"Hematology - Basophils (10^3/mm3) >1.2xULN","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]},{"title":"Chemistry - Urate (mg/dL) >1.2xULN","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"4"}]}]},{"title":"Chemistry - high-density lipoprotein cholesterol (mg/dL) <0.8xlower limit of normal (LLN)","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}]},{"title":"Chemistry - Triglycerides (mg/dL) >1.3xULN","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"}]}]},{"title":"Chemistry - Thyrotropin (uIU/mL) <0.8xLLN","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]},{"title":"Chemistry - Bile Acid (umol/L) >1.0xULN","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]},{"title":"Urinalysis - Urine Glucose ≥1","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"}]}]},{"title":"Urinalysis - Urine Ketones (Scalar) ≥1","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]}]},{"title":"Urinalysis - Urine Protein ≥1","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]},{"title":"Urinalysis - Urine Hemoglobin (Scalar) ≥1","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"}]}]},{"title":"Urinalysis - Urine Urobilinogen ≥1","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]}]},{"title":"Urinalysis - Urine Nitrite (Scalar) ≥1","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]},{"title":"Urinalysis - Urine Leukocyte Esterase (Scalar) ≥1","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]}]}]},{"type":"PRIMARY","title":"AUC24 of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961","description":"AUC24 was measured on Day 21, 35, and 56 for dose 40 mg BID, 80 mg BID, and 120 mg BID, respectively. 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