{"protocolSection":{"identificationModule":{"nctId":"NCT05579977","orgStudyIdInfo":{"id":"C3991004"},"secondaryIdInfos":[{"id":"2022-002834-15","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"Pfizer","class":"INDUSTRY"},"briefTitle":"Trial to Learn About the Study Medicine (PF-07081532) and Rybelsus in People With Type 2 Diabetes and Separately PF-07081532 in People With Obesity","officialTitle":"A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, DOSE RANGING, DOSE FINDING, PARALLEL GROUP STUDY TO ASSESS EFFICACY AND SAFETY OF PF-07081532, AND OPEN LABEL ORAL SEMAGLUTIDE, IN ADULTS WITH TYPE 2 DIABETES MELLITUS (T2DM) INADEQUATELY CONTROLLED ON METFORMIN, AND SEPARATELY PF-07081532 COMPARED TO MATCHING PLACEBO IN ADULTS WITH OBESITY BUT WITHOUT T2DM"},"statusModule":{"statusVerifiedDate":"2024-07","overallStatus":"TERMINATED","whyStopped":"The decision to terminate clinical development of PF-07081532 is based on pharmacokinetic data from Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as a Phase 2 study.","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-10-27","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-07-14","type":"ACTUAL"},"completionDateStruct":{"date":"2023-09-22","type":"ACTUAL"},"studyFirstSubmitDate":"2022-10-11","studyFirstSubmitQcDate":"2022-10-11","studyFirstPostDateStruct":{"date":"2022-10-14","type":"ACTUAL"},"resultsFirstSubmitDate":"2024-07-09","resultsFirstSubmitQcDate":"2024-07-09","resultsFirstPostDateStruct":{"date":"2024-08-01","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-07-09","lastUpdatePostDateStruct":{"date":"2024-08-01","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Pfizer","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The purpose of this study is to find out if PF-07081532 (\"the active study drug\"), is safe and helps treat people with obesity without diabetes to lose weight, and people with diabetes to keep their blood sugar in good control. Individuals diagnosed with diabetes that are on metformin or individuals with obesity without diabetes will be included in the study.\n\nThose participating in the diabetes part of the study, will receive either active study drug, placebo, or an approved treatment called Rybelsus. Those in the obesity part of the study, will receive either active study drug or placebo. The study will last for about 36 weeks except for the first 25% of the participants that enter in which case the study will last for approximately 48 weeks. during this time there will be visits every 4 weeks with phone calls in between."},"conditionsModule":{"conditions":["Diabetes Mellitus","Obesity"],"keywords":["Diabetes Mellitus","Obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":902,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"PF-07081532 20 mg T2DM","type":"EXPERIMENTAL","description":"PF-07081532 20 mg daily in T2DM","interventionNames":["Drug: PF-07081532"]},{"label":"PF-07081532 40 mg T2DM","type":"EXPERIMENTAL","description":"PF-07081532 40 mg daily in T2DM","interventionNames":["Drug: PF-07081532"]},{"label":"PF-07081532 80 mg T2DM","type":"EXPERIMENTAL","description":"PF-07081532 80 mg daily in T2DM","interventionNames":["Drug: PF-07081532"]},{"label":"PF-07081532 160 mg T2DM","type":"EXPERIMENTAL","description":"PF-07081532 160 mg daily in T2DM","interventionNames":["Drug: PF-07081532"]},{"label":"PF-07081532 260 mg T2DM","type":"EXPERIMENTAL","description":"PF-07081532 260 mg daily in T2DM","interventionNames":["Drug: PF-07081532"]},{"label":"Placebo T2DM","type":"PLACEBO_COMPARATOR","description":"Placebo daily in T2DM","interventionNames":["Other: Placebo"]},{"label":"PF-07081532 80 mg Obesity","type":"EXPERIMENTAL","description":"PF-07081532 80 mg daily in Obesity","interventionNames":["Drug: PF-07081532"]},{"label":"PF-07081532 140 mg Obesity","type":"EXPERIMENTAL","description":"PF-07081532 140 mg daily in Obesity","interventionNames":["Drug: PF-07081532"]},{"label":"PF-07081532 200 mg Obesity (Option 1)","type":"EXPERIMENTAL","description":"PF-07081532 200 mg daily in Obesity","interventionNames":["Drug: PF-07081532"]},{"label":"PF-07081532 200 mg Obesity (Option 2)","type":"EXPERIMENTAL","description":"PF-07081532 200 mg daily in Obesity","interventionNames":["Drug: PF-07081532"]},{"label":"PF-07081532 260 mg Obesity","type":"EXPERIMENTAL","description":"PF-07081532 260 mg daily in Obesity","interventionNames":["Drug: PF-07081532"]},{"label":"Rybelsus 14 mg T2DM","type":"ACTIVE_COMPARATOR","description":"Semaglutide 14 mg daily in T2DM","interventionNames":["Drug: Rybelsus"]},{"label":"Placebo Obesity","type":"PLACEBO_COMPARATOR","description":"Placebo in Obesity","interventionNames":["Other: Placebo"]}],"interventions":[{"type":"DRUG","name":"PF-07081532","description":"Oral glucagon-like peptide-1 receptor agonist","armGroupLabels":["PF-07081532 140 mg Obesity","PF-07081532 160 mg T2DM","PF-07081532 20 mg T2DM","PF-07081532 200 mg Obesity (Option 1)","PF-07081532 200 mg Obesity (Option 2)","PF-07081532 260 mg Obesity","PF-07081532 260 mg T2DM","PF-07081532 40 mg T2DM","PF-07081532 80 mg Obesity","PF-07081532 80 mg T2DM"]},{"type":"OTHER","name":"Placebo","description":"No drug","armGroupLabels":["Placebo Obesity","Placebo T2DM"]},{"type":"DRUG","name":"Rybelsus","description":"Oral Semaglutide","armGroupLabels":["Rybelsus 14 mg T2DM"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Placebo-adjusted, Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)","timeFrame":"Baseline (result closest prior to dosing on Day 1), Week 32"},{"measure":"Placebo-adjusted, Percent Change From Baseline in Body Weight at Week 32: Cohort 2 (Obesity)","description":"Body weight was measured using a calibrated weighing scale.","timeFrame":"Baseline (result closest prior to dosing on Day 1), week 32"}],"secondaryOutcomes":[{"measure":"Percentage of Participants Who Achieved HbA1C <7% at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)","timeFrame":"Baseline (result closest prior to dosing on Day 1), Week 32"},{"measure":"Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)","timeFrame":"Baseline (result closest prior to dosing on Day 1), Week 32"},{"measure":"Percent Change From Baseline in Body Weight at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)","description":"Body weight was measured using a calibrated weighing scale.","timeFrame":"Baseline (result closest prior to dosing on Day 1), Week 32"},{"measure":"Placebo-adjusted, Change From Baseline in HbA1C in the Rybelsus Arm at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)","description":"This outcome measure was planned to be analyzed only for rybelsus arm and placebo arm as pre-specified in the protocol.","timeFrame":"Baseline (result closest prior to dosing on Day 1), Week 32"},{"measure":"Percentage of Participants Achieving >=5%, >=10%, and >=15% Body Weight Loss at Week 32 Relative to Baseline: Cohort 2 (Obesity)","timeFrame":"Baseline (result closest prior to dosing on Day 1), Week 32"},{"measure":"Absolute Change From Baseline in Waist Circumference at Week 32: Cohort 2 (Obesity)","description":"Waist circumference was measured at midpoint, between lower margin of last palpable rib and top of iliac crest (approximately 1 inch \\[2.54 centimeter {cm}\\] above the navel). It was measured by using an anthropometric tape (stretch-resistant).","timeFrame":"Baseline (result closest prior to dosing on Day 1), Week 32"},{"measure":"Absolute Change From Baseline in Waist-to-hip Ratio at Week 32: Cohort 2 (Obesity)","description":"The hip circumference was defined as the circumference around the widest portion of the buttocks. Waist circumference was measured at midpoint, between lower margin of last palpable rib and top of iliac crest (approximately 1 inch \\[2.54 cm\\] above the navel). The measurements were performed using an anthropometric tape (stretch-resistant).","timeFrame":"Baseline (result closest prior to dosing on Day 1), Week 32"},{"measure":"Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 32: Cohort 2 (Obesity)","description":"HOMA-IR was calculated as: fasting plasma insulin (\\[FPI\\]\\*(FPG)/405 and measured in terms of mg/dL\\* (milliunits per liter).","timeFrame":"Baseline (result closest prior to dosing on Day 1), Week 32"},{"measure":"Change From Baseline in Homeostatic Model Assessment for Insulin Sensitivity (HOMA-S) at Week 32: Cohort 2 (Obesity)","description":"HOMA-S was calculated as (22.5/\\[FPI\\] \\* FPG) \\*100 and measured in terms of percentage sensitivity.","timeFrame":"Baseline (result closest prior to dosing on Day 1), Week 32"},{"measure":"Number of Participants With Treatment Emergent Adverse Events (TEAEs): Cohort 1 (Type 2 Diabetes Mellitus)","description":"An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any AEs that occurred on or after the first dose of treatment but before the last dose plus lag time.","timeFrame":"From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)"},{"measure":"Number of Participants With Treatment Emergent Adverse Events (TEAEs): Cohort 2 (Obesity)","description":"An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any AEs that occurred on or after the first dose of treatment but before the last dose plus lag time.","timeFrame":"From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)"},{"measure":"Number of Participants With Serious Adverse Events (SAEs): Cohort 1 (Type 2 Diabetes Mellitus)","description":"SAE defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic; other important medical events.","timeFrame":"From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)"},{"measure":"Number of Participants With Serious Adverse Events (SAEs): Cohort 2 (Obesity)","description":"SAE defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic; other important medical events.","timeFrame":"From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)"},{"measure":"Number of Participants Reporting Adverse Events Leading to Permanent Discontinuation From Study Treatment and Study: Cohort 1 (Type 2 Diabetes Mellitus)","description":"\\\\ An AE was any untoward medical occurrence in a participants or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs leading to permanent discontinuation from study were those with an AE record indicating the AE caused permanent discontinuation from the study. AEs leading to permanent discontinuation from study treatment were those AEs with an AE record indicating that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study.","timeFrame":"From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)"},{"measure":"Number of Participants Reporting Adverse Events Leading to Permanent Discontinuation From Study Treatment and Study: Cohort 2 (Obesity)","description":"An AE was any untoward medical occurrence in a participants or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs leading to permanent discontinuation from study were those with an AE record indicating the AE caused permanent discontinuation from the study. AEs leading to permanent discontinuation from study treatment were those AEs with an AE record indicating that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study.","timeFrame":"From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)"},{"measure":"Number of Participants With Hypoglycemic Adverse Events (HAE) According to Titration Dose: Cohort 1 (Type 2 Diabetes Mellitus)","description":"Glucose values were monitored using glucometer. Hypoglycemia =plasma/blood glucose value of \\<70 mg/dL (3.9 millimoles per liter \\[mmol/L\\]). Severe HAE: Participant was unable to treat him/herself due to neurological impairment (not age) and required assistance of another person, at least one neurological symptom of memory loss, confusion, uncontrolled behavior etc. Either documented blood glucose\\<=54 mg/dL (2.7 mmol/L). Documented symptomatic: An event during which symptoms of HAE were accompanied with plasma/blood glucose \\<70 mg/dL and prompt resolution with food intake, SC glucagon, or IV glucose. Probable symptomatic HAE: An event during which symptoms of an HAE were not accompanied by a plasma glucose determination but was presumably caused by a plasma glucose concentration \\<70 mg/dL and prompt resolution with food intake, SC glucagon, or IV glucose. Asymptomatic: An event not accompanied by typical symptoms of an HAE, but a plasma/blood glucose value of \\<70 mg/dL was reported.","timeFrame":"Up to week 28"},{"measure":"Number of Participants With Hypoglycemic Adverse Events According to Titration Dose: Cohort 2 (Obesity)","description":"Glucose values were monitored using glucometer. Hypoglycemia =plasma/blood glucose value of \\<70 mg/dL (3.9 mmol/L). Severe HAE: Participant was unable to treat him/herself due to neurological impairment (not age) and required assistance of another person, at least one neurological symptom of memory loss, confusion, uncontrolled behavior etc. Either documented blood glucose\\<=54 mg/dL (2.7 mmol/L). Documented symptomatic: An event during which symptoms of HAE were accompanied with plasma/blood glucose \\<70 mg/dL u and prompt resolution with food intake, SC glucagon, or IV glucose. Probable symptomatic HAE: An event during which symptoms of an HAE were not accompanied by a plasma glucose determination but was presumably caused by a plasma glucose concentration \\<70 mg/dL and prompt resolution with food intake, SC glucagon, or IV glucose. Asymptomatic: An event not accompanied by typical symptoms of an HAE, but a plasma/blood glucose value of \\<70 mg/dL was reported.","timeFrame":"Up to week 28"},{"measure":"Number of Participants With Vital Sign Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)","description":"Vital signs included blood pressure and pulse rate and were measured with the participants in a seated position after at least 5 minutes of rest for the participant. Criteria for abnormalities included: Systolic Blood Pressure (millimeter of mercury \\[mmHg\\]): value more than (\\>) 200 and value less than (\\<) 90; Diastolic blood pressure: value \\> 100 and \\< 40; Pulse rate: (beats per minute \\[BPM\\]): value \\< 40 and \\> 110.","timeFrame":"Up to week 28"},{"measure":"Number of Participants With Vital Sign Abnormalities: Cohort 2 (Obesity)","description":"Vital signs included blood pressure and pulse rate and were measured with the participants in a seated position after at least 5 minutes of rest for the participant. Criteria for abnormalities included: Systolic blood pressure (mmHg): value \\> 200 and value \\< 90; Diastolic blood pressure: value \\> 100 and \\< 40; Pulse rate: (BPM): value \\< 40 and \\> 110.","timeFrame":"Up to week 28"},{"measure":"Number of Participants With Clinical Laboratory Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)","description":"Hematology: platelets (10\\^9/L)\\< 0.5\\*lower limit of normal (LLN); leukocytes\\< 0.6\\*LLN and \\>1.5\\*upper limit of normal (ULN); lymphocytes and neutrophils \\<0.8\\*LLN and \\>1.2\\*ULN; basophils, eosinophils, monocytes:\\>1.2\\*ULN; prothrombin time (sec) \\>1.1\\*ULN; prothrombin international normalized ratio \\>1.1\\*ULN; clinical chemistry: bilirubin (mg/dL), indirect bilirubin:\\>1.5\\*ULN; aspartate and alanine aminotransferase, gamma glutamyl transferase (U/L):\\>3.0\\*ULN; urea nitrogen and creatinine (mg/dL)\\>1.3\\* ULN;HDL cholesterol (mg/dL)\\<0.8\\*LLN; LDL (mg/dL)\\>1.2\\*ULN, Triglycerides (mg/dL):\\>1.3\\*ULN; Potassium (milliequivalents per liter) \\< 0.9\\*LLN and \\> 1.1\\* ULN; calcium (mg/dL)\\< 0.9\\*LLN, Thyroxine (nanograms/dL\\<0.8\\*LLN and \\>1.2\\*ULN, HbA1C (%)\\>1.3\\*ULN; Amylase, Lipase (U/L) and Glucose -Fasting (mg/dL)\\>1.5\\*ULN; urinalysis: pH\\> 8; urine glucose, ketones, protein, hemoglobin, nitrite and leukocyte esterase\\>=1. Number of participants with abnormalities in any of the laboratory parameters is reported.","timeFrame":"Up to week 28"},{"measure":"Number of Participants With Clinical Laboratory Abnormalities: Cohort 2 (Obesity)","description":"Hematology: platelets (10\\^9/L)\\< 0.5\\* LLN; leukocytes\\< 0.6\\*LLN and \\>1.5\\*ULN; lymphocytes and neutrophils \\<0.8\\*LLN and \\>1.2\\*ULN; basophils, eosinophils, monocytes:\\>1.2\\*ULN; prothrombin time (sec) \\>1.1\\*ULN; prothrombin international normalized ratio \\>1.1\\*ULN; clinical chemistry: bilirubin (mg/dL), indirect bilirubin:\\>1.5\\*ULN; aspartate and alanine aminotransferase, gamma glutamyl transferase (U/L):\\>3.0\\*ULN; urea nitrogen and creatinine (mg/dL)\\>1.3\\* ULN;HDL cholesterol (mg/dL)\\<0.8\\*LLN; LDL (mg/dL)\\>1.2\\*ULN, Triglycerides (mg/dL):\\>1.3\\*ULN; Potassium (milliequivalents per liter) \\< 0.9\\*LLN and \\> 1.1\\* ULN; calcium (mg/dL)\\< 0.9\\*LLN, Thyroxine (nanograms/dL\\<0.8\\*LLN and \\>1.2\\*ULN, HbA1C (%)\\>1.3\\*ULN; Amylase, Lipase (U/L) and Glucose -Fasting (mg/dL)\\>1.5\\*ULN; urinalysis: pH\\> 8; urine glucose, ketones, protein, hemoglobin, nitrite and leukocyte esterase\\>=1. Number of participants with abnormalities in any of the laboratory parameters is reported.","timeFrame":"Up to week 28"},{"measure":"Number of Participants With ECG Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)","description":"Standard 12-lead ECGs were performed after the participant had rested quietly for more than 10 minutes in a supine position utilizing an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QT interval corrected using Fridericia's formula (QTcF), and QRS complex. ECG abnormalities were categorized as: PR interval (milliseconds \\[msec\\]), Value \\>= 300; percent change (%Chg) greater than equal (\\>=) 25/50%. QRS duration (msec): Value \\>= 140 and %Chg \\>= 50%. QT interval (msec): Value \\> 500; QTCF interval (msec): 450 \\< Value \\<= 480, 480 \\< Value \\<= 500, Value \\> 500; 30 \\<= Change (Chg) \\<= 60; Chg \\> 60.","timeFrame":"Up to week 28"},{"measure":"Number of Participants With ECG Abnormalities: Cohort 2 (Obesity)","description":"Standard 12-lead ECGs were performed after the participant had rested quietly for more than 10 minutes in a supine position utilizing an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF, and QRS complex. ECG abnormalities were categorized as: PR interval msec, Value \\>= 300; percentage change (%Chg) \\>= 25/50%. QRS duration (msec): Value \\>= 140 and %Chg \\>= 50%. QT interval (msec): Value \\> 500; QTCF interval (msec): 450 \\< Value \\<= 480, 480 \\< Value \\<= 500, Value \\> 500; 30 \\<= Change (Chg) \\<= 60; Chg \\> 60.","timeFrame":"Up to week 28"},{"measure":"Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS) Category: Cohort 2 (Obesity) Only","description":"C-SSRS is an interview-based rating scale to assess suicidal ideation and suicidal behavior and had a binary response (yes/no). C-SSRS data was mapped to C-CASA per Guidance for Industry: Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials. A participant was said to have suicidal behavior in case of any of following events: 1) completed suicide; 2) suicide attempt; or 3) preparatory acts toward imminent suicidal behavior. A participant showed suicidal ideation if they responded 'yes' to any of the 5 questions, 'Wish to be dead; Non-Specific Active Suicidal Thoughts Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent. The participant was said to exhibit Self-injurious behavior, no suicidal intent if they responded as Yes to 'Has participant engaged in Non-suicidal Self-Injurious Behavior","timeFrame":"Baseline (result closest prior to dosing on Day 1), anytime post-baseline (Up to Week 28)"}],"otherOutcomes":[{"measure":"Placebo-adjusted, Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)","description":"Analysis was performed using mixed model repeated measures (MMRM) model including treatment, gender strata and time as fixed effects, baseline\\*time interaction, time\\*treatment interaction, and baseline as a covariate with time fitted as a repeated effect and participant as a random effect.","timeFrame":"Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16"},{"measure":"Placebo-adjusted, Percent Change From Baseline in Body Weight at Week 20: Cohort 2 (Obesity)","description":"Body weight was measured using a calibrated weighing scale. Analysis was performed using MMRM model including treatment, gender strata and time as fixed effects, baseline\\*time interaction, time\\*treatment interaction, and baseline as a covariate with time fitted as a repeated effect and participant as a random effect.","timeFrame":"Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 20"},{"measure":"Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)","timeFrame":"Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16"},{"measure":"Percent Change From Baseline in Body Weight at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)","description":"Body weight was measured using a calibrated weighing scale.","timeFrame":"Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16"},{"measure":"Placebo-adjusted, Change From Baseline in Percentage of HbA1C in the Rybelsus Arm Versus Placebo Arm at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)","description":"Analysis was performed using MMRM model including treatment, gender strata and time as fixed effects, baseline\\*time interaction, time\\*treatment interaction, and baseline as a covariate with time fitted as a repeated effect and participant as a random effect. This outcome measure was planned to be analyzed only for rybelsus arm and placebo arm as pre-specified in the protocol.","timeFrame":"Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16"},{"measure":"Absolute Change From Baseline in Waist Circumference at Week 12 and 24: Cohort 2 (Obesity)","description":"Waist circumference was measured at midpoint, between lower margin of last palpable rib and top of iliac crest (approximately 1 inch \\[2.54 cm\\] above the navel). It was measured by using an anthropometric tape (stretch-resistant).","timeFrame":"Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], Week 12, 24"},{"measure":"Absolute Change From Baseline in Waist-to-hip Ratio at Week 12 and Week 24: Cohort 2 (Obesity)","description":"The hip circumference was defined as the circumference around the widest portion of the buttocks. Waist circumference was measured at midpoint, between lower margin of last palpable rib and top of iliac crest (approximately 1 inch \\[2.54 cm\\] above the navel). The measurements were performed using an anthropometric tape (stretch-resistant).","timeFrame":"Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], week 12, 24"},{"measure":"Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 16: Cohort 2 (Obesity)","description":"HOMA-IR was calculated as: (\\[FPI\\]\\*(FPG)/405 in terms of Mg/dL\\* (milliunits per liter).","timeFrame":"Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16"},{"measure":"Change From Baseline in Homeostatic Model Assessment for Insulin Sensitivity (HOMA-S) at Week 16: Cohort 2 (Obesity)","description":"HOMA-S was calculated as (22.5/\\[FPI\\]\\*FPG)) \\*100 and measured in terms of. percentage sensitivity.","timeFrame":"Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\nT2DM\n\n* T2DM inadequately controlled with metformin\n* BMI ≥23.0 kg/m2 (≥20.0 kg/m2 in Japan)\n* HbA1C of 7% to 10% (53-86 mmol/mol)\n* FPG ≤270 mg/dL (15 mmol/L)\n\nObesity\n\n* BMI ≥30.0 kg/m2\n* HbA1C ≤6.4% (47 mmol/mol)\n* FPG ≤126 mg/dL (7 mmol/L)\n\nExclusion Criteria:\n\n* Any of the following: Active/current, symptomatic gallbladder disease; History of pancreatitis in the prior 2-months;History of Type 1 Diabetes Mellitus, or secondary forms of diabetes; Any condition affecting drug absorption; Medical history of active liver disease (other than non-alcoholic hepatic steatosis)\n* Use of pharmacological agents with approved indication for weight loss\n* T2DM:Use of any agent (other than metformin)for the explicit purpose of glycemic control;History of diabetic ketoacidosis;Proliferative retinopathy or maculopathy requiring acute treatment;\n* Obesity: Previous or planned weight reduction surgery; Major depressive disorder or other severe psychiatric disorders; Any lifetime history of a suicide attempt; PHQ-9 score ≥15; Response of \"yes\" to Question 4 or 5, or on any suicidal behavioral question on the C-SSRS\n* Clinically significant cardiovascular conditions\n* Uncontrolled blood pressure\n* Personal or within first-degree relative family history of MTC or MEN2\n* Other medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study\n* Any of the following central lab results: Fasting C-peptide \\<0.8 ng/mL; ALT or AST ≥2.5x ULN; Direct bilirubin \\>ULN or T Bili \\>1.5x ULN except when participants have a history of Gilbert syndrome ; TSH \\>1.5x ULN or \\<LLN; Serum calcitonin \\>ULN; Serum amylase or serum lipase \\>ULN; eGFR \\<45 ml/min/1.73 ; Active Hepatitis B, or Hepatitis C; A positive urine drug test for illicit drugs","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Pfizer CT.gov Call Center","affiliation":"Pfizer","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Trinity Clinical Research","city":"Centreville","state":"Alabama","zip":"35042","country":"United States","geoPoint":{"lat":32.9462,"lon":-87.11669}},{"facility":"Anaheim Clinical Trials, LLC","city":"Anaheim","state":"California","zip":"92801","country":"United States","geoPoint":{"lat":33.83529,"lon":-117.9145}},{"facility":"San Fernando Valley Health Institute","city":"Canoga Park","state":"California","zip":"91304","country":"United States","geoPoint":{"lat":34.20112,"lon":-118.59814}},{"facility":"Catalina Research Institute, LLC","city":"Montclair","state":"California","zip":"91763","country":"United States","geoPoint":{"lat":34.07751,"lon":-117.68978}},{"facility":"Empire Clinical Research","city":"Pomona","state":"California","zip":"91767","country":"United States","geoPoint":{"lat":34.05529,"lon":-117.75228}},{"facility":"University Clinical Investigators, Inc.","city":"Tustin","state":"California","zip":"92780","country":"United States","geoPoint":{"lat":33.74585,"lon":-117.82617}},{"facility":"Diablo Clinical Research, Inc.","city":"Walnut Creek","state":"California","zip":"94598","country":"United States","geoPoint":{"lat":37.90631,"lon":-122.06496}},{"facility":"Innovative Research of West Florida","city":"Clearwater","state":"Florida","zip":"33756","country":"United States","geoPoint":{"lat":27.96585,"lon":-82.8001}},{"facility":"Jacksonville Center for Clinical Research","city":"Jacksonville","state":"Florida","zip":"32216","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Adult Medicine of Lake County","city":"Mt. 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Emerging pharmacotherapies for obesity: A systematic review. Pharmacol Rev. 2025 Jan;77(1):100002. doi: 10.1124/pharmrev.123.001045. Epub 2024 Nov 22."},{"pmid":"39415344","type":"DERIVED","citation":"Amin NB, Frederich R, Tsamandouras N, Haggag AZ, Schuster T, Zmuda W, Palmer A, Vasas S, Buckley G, Smith TR, DuBrava SJ, Zhu Q, Johnson M. Evaluation of an oral small-molecule glucagon-like peptide-1 receptor agonist, lotiglipron, for type 2 diabetes and obesity: A dose-ranging, phase 2, randomized, placebo-controlled study. Diabetes Obes Metab. 2025 Jan;27(1):215-227. doi: 10.1111/dom.16005. Epub 2024 Oct 16."}],"seeAlsoLinks":[{"label":"To obtain contact information for a study center near you, click here.","url":"https://pmiform.com/clinical-trial-info-request?StudyID=C3991004"}]},"ipdSharingStatementModule":{"ipdSharing":"YES","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.","url":"https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"A total of 902 participants were randomized in this study of which 1 participant did not receive treatment. The study was terminated based on pharmacokinetic data from Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as this Phase 2 study.","recruitmentDetails":"This study had 2 cohorts: Cohort 1 included participants with type 2 diabetes mellitus (T2DM) on a background therapy of metformin. 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followed by PF-07081532 200 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved HbA1C <7% at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)","populationDescription":"Data was not collected for this outcome measure as the study was terminated prior to any participant reaching Week 32.","reportingStatus":"POSTED","timeFrame":"Baseline (result closest prior to dosing on Day 1), Week 32","groups":[{"id":"OG000","title":"Placebo (T2DM)","description":"Participants randomized to receive a 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mg QD orally."},{"id":"OG006","title":"Rybelsus 14mg (T2DM)","description":"Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"}]}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)","populationDescription":"Data was not collected for this outcome measure as the study was terminated prior to any participant reaching Week 32.","reportingStatus":"POSTED","timeFrame":"Baseline (result closest prior to dosing on Day 1), Week 32","groups":[{"id":"OG000","title":"Placebo (T2DM)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 20mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally."},{"id":"OG002","title":"PF-07081532 40mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally."},{"id":"OG003","title":"PF-07081532 80mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG004","title":"PF-07081532 160mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD 40 mg QD, 60 mg QD, 80 mg QD and 120 mg QD orally for 4 weeks, followed by PF-07081532 160 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD, 80 mg QD, 140 mg QD and 200 mg QD orally for 4 weeks, followed by PF-07081532 260 mg QD orally."},{"id":"OG006","title":"Rybelsus 14mg (T2DM)","description":"Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"}]}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Body Weight at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)","description":"Body weight was measured using a calibrated weighing scale.","populationDescription":"Data was not collected for this outcome measure as the study was terminated prior to any participant reaching Week 32.","reportingStatus":"POSTED","timeFrame":"Baseline (result closest prior to dosing on Day 1), Week 32","groups":[{"id":"OG000","title":"Placebo (T2DM)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 20mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally."},{"id":"OG002","title":"PF-07081532 40mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally."},{"id":"OG003","title":"PF-07081532 80mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG004","title":"PF-07081532 160mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD 40 mg QD, 60 mg QD, 80 mg QD and 120 mg QD orally for 4 weeks, followed by PF-07081532 160 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD, 80 mg QD, 140 mg QD and 200 mg QD orally for 4 weeks, followed by PF-07081532 260 mg QD orally."},{"id":"OG006","title":"Rybelsus 14mg (T2DM)","description":"Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"}]}]},{"type":"SECONDARY","title":"Placebo-adjusted, Change From Baseline in HbA1C in the Rybelsus Arm at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)","description":"This outcome measure was planned to be analyzed only for rybelsus arm and placebo arm as pre-specified in the protocol.","populationDescription":"Data was not collected for this outcome measure as the study was terminated prior to any participant reaching Week 32.","reportingStatus":"POSTED","timeFrame":"Baseline (result closest prior to dosing on Day 1), Week 32","groups":[{"id":"OG000","title":"Placebo (T2DM)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"Rybelsus 14mg (T2DM)","description":"Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving >=5%, >=10%, and >=15% Body Weight Loss at Week 32 Relative to Baseline: Cohort 2 (Obesity)","populationDescription":"Data was not collected for this outcome measure as the study was terminated prior to any participant reaching Week 32.","reportingStatus":"POSTED","timeFrame":"Baseline (result closest prior to dosing on Day 1), Week 32","groups":[{"id":"OG000","title":"Placebo (Obesity)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 80mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG002","title":"PF-07081532 140mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD,120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally."},{"id":"OG003","title":"PF-07081532 200mg (Obesity,5 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD,160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG004","title":"PF-07081532 200mg (Obesity,4 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]},{"type":"SECONDARY","title":"Absolute Change From Baseline in Waist Circumference at Week 32: Cohort 2 (Obesity)","description":"Waist circumference was measured at midpoint, between lower margin of last palpable rib and top of iliac crest (approximately 1 inch \\[2.54 centimeter {cm}\\] above the navel). It was measured by using an anthropometric tape (stretch-resistant).","populationDescription":"Data was not collected for this outcome measure as the study was terminated prior to any participant reaching Week 32.","reportingStatus":"POSTED","timeFrame":"Baseline (result closest prior to dosing on Day 1), Week 32","groups":[{"id":"OG000","title":"Placebo (Obesity)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 80mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG002","title":"PF-07081532 140mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD,120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally."},{"id":"OG003","title":"PF-07081532 200mg (Obesity,5 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD,160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG004","title":"PF-07081532 200mg (Obesity,4 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]},{"type":"SECONDARY","title":"Absolute Change From Baseline in Waist-to-hip Ratio at Week 32: Cohort 2 (Obesity)","description":"The hip circumference was defined as the circumference around the widest portion of the buttocks. Waist circumference was measured at midpoint, between lower margin of last palpable rib and top of iliac crest (approximately 1 inch \\[2.54 cm\\] above the navel). The measurements were performed using an anthropometric tape (stretch-resistant).","populationDescription":"Data was not collected for this outcome measure as the study was terminated prior to any participant reaching Week 32.","reportingStatus":"POSTED","timeFrame":"Baseline (result closest prior to dosing on Day 1), Week 32","groups":[{"id":"OG000","title":"Placebo (Obesity)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 80mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG002","title":"PF-07081532 140mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD,120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally."},{"id":"OG003","title":"PF-07081532 200mg (Obesity,5 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD,160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG004","title":"PF-07081532 200mg (Obesity,4 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]},{"type":"SECONDARY","title":"Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 32: Cohort 2 (Obesity)","description":"HOMA-IR was calculated as: fasting plasma insulin (\\[FPI\\]\\*(FPG)/405 and measured in terms of mg/dL\\* (milliunits per liter).","populationDescription":"Data was not collected for this outcome measure as the study was terminated prior to any participant reaching Week 32.","reportingStatus":"POSTED","timeFrame":"Baseline (result closest prior to dosing on Day 1), Week 32","groups":[{"id":"OG000","title":"Placebo (Obesity)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 80mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG002","title":"PF-07081532 140mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD,120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally."},{"id":"OG003","title":"PF-07081532 200mg (Obesity,5 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD,160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG004","title":"PF-07081532 200mg (Obesity,4 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]},{"type":"SECONDARY","title":"Change From Baseline in Homeostatic Model Assessment for Insulin Sensitivity (HOMA-S) at Week 32: Cohort 2 (Obesity)","description":"HOMA-S was calculated as (22.5/\\[FPI\\] \\* FPG) \\*100 and measured in terms of percentage sensitivity.","populationDescription":"Data was not collected for this outcome measure as the study was terminated prior to any participant reaching Week 32.","reportingStatus":"POSTED","timeFrame":"Baseline (result closest prior to dosing on Day 1), Week 32","groups":[{"id":"OG000","title":"Placebo (Obesity)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 80mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG002","title":"PF-07081532 140mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD,120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally."},{"id":"OG003","title":"PF-07081532 200mg (Obesity,5 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD,160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG004","title":"PF-07081532 200mg (Obesity,4 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]},{"type":"SECONDARY","title":"Number of Participants With Treatment Emergent Adverse Events (TEAEs): Cohort 1 (Type 2 Diabetes Mellitus)","description":"An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any AEs that occurred on or after the first dose of treatment but before the last dose plus lag time.","populationDescription":"Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)","groups":[{"id":"OG000","title":"Placebo (T2DM)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 20mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally."},{"id":"OG002","title":"PF-07081532 40mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally."},{"id":"OG003","title":"PF-07081532 80mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG004","title":"PF-07081532 160mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD 40 mg QD, 60 mg QD, 80 mg QD and 120 mg QD orally for 4 weeks, followed by PF-07081532 160 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD, 80 mg QD, 140 mg QD and 200 mg QD orally for 4 weeks, followed by PF-07081532 260 mg QD orally."},{"id":"OG006","title":"Rybelsus 14mg (T2DM)","description":"Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"73"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"73"},{"groupId":"OG004","value":"72"},{"groupId":"OG005","value":"74"},{"groupId":"OG006","value":"73"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"50"},{"groupId":"OG003","value":"44"},{"groupId":"OG004","value":"45"},{"groupId":"OG005","value":"56"},{"groupId":"OG006","value":"36"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Treatment Emergent Adverse Events (TEAEs): Cohort 2 (Obesity)","description":"An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any AEs that occurred on or after the first dose of treatment but before the last dose plus lag time.","populationDescription":"Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)","groups":[{"id":"OG000","title":"Placebo (Obesity)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 80mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG002","title":"PF-07081532 140mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD,120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally."},{"id":"OG003","title":"PF-07081532 200mg (Obesity,5 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD,160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG004","title":"PF-07081532 200mg (Obesity,4 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"66"},{"groupId":"OG002","value":"64"},{"groupId":"OG003","value":"65"},{"groupId":"OG004","value":"66"},{"groupId":"OG005","value":"64"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"54"},{"groupId":"OG002","value":"50"},{"groupId":"OG003","value":"56"},{"groupId":"OG004","value":"60"},{"groupId":"OG005","value":"53"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Serious Adverse Events (SAEs): Cohort 1 (Type 2 Diabetes Mellitus)","description":"SAE defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic; other important medical events.","populationDescription":"Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)","groups":[{"id":"OG000","title":"Placebo (T2DM)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 20mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally."},{"id":"OG002","title":"PF-07081532 40mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally."},{"id":"OG003","title":"PF-07081532 80mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG004","title":"PF-07081532 160mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD 40 mg QD, 60 mg QD, 80 mg QD and 120 mg QD orally for 4 weeks, followed by PF-07081532 160 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD, 80 mg QD, 140 mg QD and 200 mg QD orally for 4 weeks, followed by PF-07081532 260 mg QD orally."},{"id":"OG006","title":"Rybelsus 14mg (T2DM)","description":"Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"73"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"73"},{"groupId":"OG004","value":"72"},{"groupId":"OG005","value":"74"},{"groupId":"OG006","value":"73"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"1"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Serious Adverse Events (SAEs): Cohort 2 (Obesity)","description":"SAE defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic; other important medical events.","populationDescription":"Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)","groups":[{"id":"OG000","title":"Placebo (Obesity)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 80mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG002","title":"PF-07081532 140mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD,120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally."},{"id":"OG003","title":"PF-07081532 200mg (Obesity,5 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD,160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG004","title":"PF-07081532 200mg (Obesity,4 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"66"},{"groupId":"OG002","value":"64"},{"groupId":"OG003","value":"65"},{"groupId":"OG004","value":"66"},{"groupId":"OG005","value":"64"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"2"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Reporting Adverse Events Leading to Permanent Discontinuation From Study Treatment and Study: Cohort 1 (Type 2 Diabetes Mellitus)","description":"\\\\ An AE was any untoward medical occurrence in a participants or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs leading to permanent discontinuation from study were those with an AE record indicating the AE caused permanent discontinuation from the study. AEs leading to permanent discontinuation from study treatment were those AEs with an AE record indicating that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study.","populationDescription":"Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)","groups":[{"id":"OG000","title":"Placebo (T2DM)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 20mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally."},{"id":"OG002","title":"PF-07081532 40mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally."},{"id":"OG003","title":"PF-07081532 80mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG004","title":"PF-07081532 160mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD 40 mg QD, 60 mg QD, 80 mg QD and 120 mg QD orally for 4 weeks, followed by PF-07081532 160 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD, 80 mg QD, 140 mg QD and 200 mg QD orally for 4 weeks, followed by PF-07081532 260 mg QD orally."},{"id":"OG006","title":"Rybelsus 14mg (T2DM)","description":"Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"73"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"73"},{"groupId":"OG004","value":"72"},{"groupId":"OG005","value":"74"},{"groupId":"OG006","value":"73"}]}],"classes":[{"title":"Discontinuations from study due to TEAEs","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"}]}]},{"title":"Permanent discontinuations from any study intervention due to TEAEs","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"5"},{"groupId":"OG005","value":"17"},{"groupId":"OG006","value":"5"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Reporting Adverse Events Leading to Permanent Discontinuation From Study Treatment and Study: Cohort 2 (Obesity)","description":"An AE was any untoward medical occurrence in a participants or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs leading to permanent discontinuation from study were those with an AE record indicating the AE caused permanent discontinuation from the study. AEs leading to permanent discontinuation from study treatment were those AEs with an AE record indicating that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study.","populationDescription":"Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)","groups":[{"id":"OG000","title":"Placebo (Obesity)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 80mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG002","title":"PF-07081532 140mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD,120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally."},{"id":"OG003","title":"PF-07081532 200mg (Obesity,5 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD,160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG004","title":"PF-07081532 200mg (Obesity,4 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"66"},{"groupId":"OG002","value":"64"},{"groupId":"OG003","value":"65"},{"groupId":"OG004","value":"66"},{"groupId":"OG005","value":"64"}]}],"classes":[{"title":"Discontinuations from study due to TEAEs","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"}]}]},{"title":"Permanent discontinuations from any study intervention due to TEAEs","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"19"},{"groupId":"OG003","value":"15"},{"groupId":"OG004","value":"24"},{"groupId":"OG005","value":"22"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Hypoglycemic Adverse Events (HAE) According to Titration Dose: Cohort 1 (Type 2 Diabetes Mellitus)","description":"Glucose values were monitored using glucometer. Hypoglycemia =plasma/blood glucose value of \\<70 mg/dL (3.9 millimoles per liter \\[mmol/L\\]). Severe HAE: Participant was unable to treat him/herself due to neurological impairment (not age) and required assistance of another person, at least one neurological symptom of memory loss, confusion, uncontrolled behavior etc. Either documented blood glucose\\<=54 mg/dL (2.7 mmol/L). Documented symptomatic: An event during which symptoms of HAE were accompanied with plasma/blood glucose \\<70 mg/dL and prompt resolution with food intake, SC glucagon, or IV glucose. Probable symptomatic HAE: An event during which symptoms of an HAE were not accompanied by a plasma glucose determination but was presumably caused by a plasma glucose concentration \\<70 mg/dL and prompt resolution with food intake, SC glucagon, or IV glucose. Asymptomatic: An event not accompanied by typical symptoms of an HAE, but a plasma/blood glucose value of \\<70 mg/dL was reported.","populationDescription":"Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies total number of participants with at least one dose of the given titration dose level after pooling of data across each titration dose.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Up to week 28","groups":[{"id":"OG000","title":"Placebo (T2DM","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 20mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally."},{"id":"OG002","title":"PF-07081532 40 mg (T2DM)","description":"Participants with T2DM inadequately controlled with metformin who received PF-07081532 40 mg QD orally were included."},{"id":"OG003","title":"PF-07081532 60mg (T2DM)","description":"Participants with T2DM inadequately controlled with metformin who received PF-07081532 60 mg QD orally were included."},{"id":"OG004","title":"PF-07081532 80 mg (T2DM)","description":"Participants with T2DM inadequately controlled with metformin who received PF-07081532 80 mg QD orally were included."},{"id":"OG005","title":"PF-07081532 120 mg (T2DM)","description":"Participants with T2DM inadequately controlled with metformin who received PF-07081532 120 mg QD orally were included."},{"id":"OG006","title":"PF-07081532 140mg (T2DM)","description":"Participants with T2DM inadequately controlled with metformin who received PF-07081532 140 mg QD orally were included."},{"id":"OG007","title":"PF-07081532 160mg (T2DM)","description":"Participants with T2DM inadequately controlled with metformin who received PF-07081532 160 mg QD orally were included."},{"id":"OG008","title":"PF-07081532 200mg (T2DM)","description":"Participants with T2DM inadequately controlled with metformin who received PF-07081532 200 mg QD orally were included."},{"id":"OG009","title":"PF-07081532 260 mg (T2DM)","description":"Participants with T2DM inadequately controlled with metformin who received PF-07081532 260 mg QD orally were included."},{"id":"OG010","title":"Rybelsus 3mg (T2DM)","description":"Participants with T2DM inadequately controlled with metformin who received Rybelsus 3 mg QD orally were included."},{"id":"OG011","title":"Rybelsus 7mg (T2DM)","description":"Participants with T2DM inadequately controlled with metformin who received Rybelsus 7 mg QD orally were included."},{"id":"OG012","title":"Rybelsus 14mg (T2DM)","description":"Participants with T2DM inadequately controlled with metformin who received Rybelsus 14 mg QD orally were included."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"364"},{"groupId":"OG002","value":"281"},{"groupId":"OG003","value":"136"},{"groupId":"OG004","value":"193"},{"groupId":"OG005","value":"25"},{"groupId":"OG006","value":"58"},{"groupId":"OG007","value":"7"},{"groupId":"OG008","value":"20"},{"groupId":"OG009","value":"6"},{"groupId":"OG010","value":"73"},{"groupId":"OG011","value":"72"},{"groupId":"OG012","value":"70"}]}],"classes":[{"title":"Severe Hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"0"}]}]},{"title":"Documented Symptomatic Hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"2"},{"groupId":"OG011","value":"2"},{"groupId":"OG012","value":"1"}]}]},{"title":"Asymptomatic Hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"1"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"1"},{"groupId":"OG012","value":"2"}]}]},{"title":"Probable Symptomatic Hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"1"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Hypoglycemic Adverse Events According to Titration Dose: Cohort 2 (Obesity)","description":"Glucose values were monitored using glucometer. Hypoglycemia =plasma/blood glucose value of \\<70 mg/dL (3.9 mmol/L). Severe HAE: Participant was unable to treat him/herself due to neurological impairment (not age) and required assistance of another person, at least one neurological symptom of memory loss, confusion, uncontrolled behavior etc. Either documented blood glucose\\<=54 mg/dL (2.7 mmol/L). Documented symptomatic: An event during which symptoms of HAE were accompanied with plasma/blood glucose \\<70 mg/dL u and prompt resolution with food intake, SC glucagon, or IV glucose. Probable symptomatic HAE: An event during which symptoms of an HAE were not accompanied by a plasma glucose determination but was presumably caused by a plasma glucose concentration \\<70 mg/dL and prompt resolution with food intake, SC glucagon, or IV glucose. Asymptomatic: An event not accompanied by typical symptoms of an HAE, but a plasma/blood glucose value of \\<70 mg/dL was reported.","populationDescription":"Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies total number of participants with at least one dose of the given titration dose level after pooling of data across each titration dose.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Up to week 28","groups":[{"id":"OG000","title":"Placebo (Obesity)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 20mg (Obesity)","description":"Participants with obesity who received PF-07081532 20 mg QD orally were included."},{"id":"OG002","title":"PF-07081532 40 mg (Obesity)","description":"Participants with obesity who received PF-07081532 40 mg QD orally were included."},{"id":"OG003","title":"PF-07081532 60 mg (Obesity)","description":"Participants with obesity who received PF-07081532 60 mg QD orally were included."},{"id":"OG004","title":"PF-07081532 80mg (Obesity)","description":"Participants with obesity who received PF-07081532 80 mg QD orally were included."},{"id":"OG005","title":"PF-07081532 100 mg (Obesity)","description":"Participants with obesity who received PF-07081532 100 mg QD orally were included."},{"id":"OG006","title":"PF-07081532 120 mg (Obesity)","description":"Participants with obesity who received PF-07081532 120 mg QD orally were included."},{"id":"OG007","title":"PF-07081532 140mg (Obesity)","description":"Participants with obesity who received PF-07081532 140 mg QD orally were included."},{"id":"OG008","title":"PF-07081532 160 mg (Obesity)","description":"Participants with obesity who received PF-07081532 160 mg QD orally were included."},{"id":"OG009","title":"PF-07081532 200 mg (Obesity)","description":"Participants with obesity who received PF-07081532 200 mg QD orally were included."},{"id":"OG010","title":"PF-07081532 260 mg (Obesity)","description":"Participants with obesity who received PF-07081532 260 mg QD orally were included."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"325"},{"groupId":"OG002","value":"310"},{"groupId":"OG003","value":"170"},{"groupId":"OG004","value":"220"},{"groupId":"OG005","value":"56"},{"groupId":"OG006","value":"43"},{"groupId":"OG007","value":"140"},{"groupId":"OG008","value":"47"},{"groupId":"OG009","value":"121"},{"groupId":"OG010","value":"28"}]}],"classes":[{"title":"Severe Hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"}]}]},{"title":"Documented Symptomatic Hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"}]}]},{"title":"Asymptomatic Hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"}]}]},{"title":"Probable Symptomatic Hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"1"},{"groupId":"OG010","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Vital Sign Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)","description":"Vital signs included blood pressure and pulse rate and were measured with the participants in a seated position after at least 5 minutes of rest for the participant. Criteria for abnormalities included: Systolic Blood Pressure (millimeter of mercury \\[mmHg\\]): value more than (\\>) 200 and value less than (\\<) 90; Diastolic blood pressure: value \\> 100 and \\< 40; Pulse rate: (beats per minute \\[BPM\\]): value \\< 40 and \\> 110.","populationDescription":"Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Up to week 28","groups":[{"id":"OG000","title":"Placebo (T2DM)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 20mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally."},{"id":"OG002","title":"PF-07081532 40mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally."},{"id":"OG003","title":"PF-07081532 80mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG004","title":"PF-07081532 160mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD 40 mg QD, 60 mg QD, 80 mg QD and 120 mg QD orally for 4 weeks, followed by PF-07081532 160 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD, 80 mg QD, 140 mg QD and 200 mg QD orally for 4 weeks, followed by PF-07081532 260 mg QD orally."},{"id":"OG006","title":"Rybelsus 14 mg (T2DM)","description":"Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"73"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"73"},{"groupId":"OG004","value":"72"},{"groupId":"OG005","value":"74"},{"groupId":"OG006","value":"73"}]}],"classes":[{"title":"Systolic Blood Pressure (mmHg) Value <90 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"}]}]},{"title":"Systolic Blood Pressure (mmHg) Value >200 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"}]}]},{"title":"Diastolic Blood Pressure (mmHg) Value <40 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"}]}]},{"title":"Diastolic Blood Pressure (mmHg) Value >100 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"2"}]}]},{"title":"Pulse Rate (bpm) Value <40 bpm","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"}]}]},{"title":"Pulse Rate (bpm) Value >110 bpm","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Vital Sign Abnormalities: Cohort 2 (Obesity)","description":"Vital signs included blood pressure and pulse rate and were measured with the participants in a seated position after at least 5 minutes of rest for the participant. Criteria for abnormalities included: Systolic blood pressure (mmHg): value \\> 200 and value \\< 90; Diastolic blood pressure: value \\> 100 and \\< 40; Pulse rate: (BPM): value \\< 40 and \\> 110.","populationDescription":"Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Up to week 28","groups":[{"id":"OG000","title":"Placebo (Obesity)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 80mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG002","title":"PF-07081532 140mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD,120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally."},{"id":"OG003","title":"PF-07081532 200mg (Obesity,5 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD,160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG004","title":"PF-07081532 200mg (Obesity,4 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"66"},{"groupId":"OG002","value":"64"},{"groupId":"OG003","value":"65"},{"groupId":"OG004","value":"66"},{"groupId":"OG005","value":"64"}]}],"classes":[{"title":"Systolic Blood Pressure (mmHg) Value <90 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"}]}]},{"title":"Systolic Blood Pressure (mmHg) Value >200 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]},{"title":"Diastolic Blood Pressure (mmHg) Value <40 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]},{"title":"Diastolic Blood Pressure (mmHg) Value >100 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"3"}]}]},{"title":"Pulse Rate (bpm) Value <40 bpm","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]},{"title":"Pulse Rate (bpm) Value >110 bpm","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Clinical Laboratory Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)","description":"Hematology: platelets (10\\^9/L)\\< 0.5\\*lower limit of normal (LLN); leukocytes\\< 0.6\\*LLN and \\>1.5\\*upper limit of normal (ULN); lymphocytes and neutrophils \\<0.8\\*LLN and \\>1.2\\*ULN; basophils, eosinophils, monocytes:\\>1.2\\*ULN; prothrombin time (sec) \\>1.1\\*ULN; prothrombin international normalized ratio \\>1.1\\*ULN; clinical chemistry: bilirubin (mg/dL), indirect bilirubin:\\>1.5\\*ULN; aspartate and alanine aminotransferase, gamma glutamyl transferase (U/L):\\>3.0\\*ULN; urea nitrogen and creatinine (mg/dL)\\>1.3\\* ULN;HDL cholesterol (mg/dL)\\<0.8\\*LLN; LDL (mg/dL)\\>1.2\\*ULN, Triglycerides (mg/dL):\\>1.3\\*ULN; Potassium (milliequivalents per liter) \\< 0.9\\*LLN and \\> 1.1\\* ULN; calcium (mg/dL)\\< 0.9\\*LLN, Thyroxine (nanograms/dL\\<0.8\\*LLN and \\>1.2\\*ULN, HbA1C (%)\\>1.3\\*ULN; Amylase, Lipase (U/L) and Glucose -Fasting (mg/dL)\\>1.5\\*ULN; urinalysis: pH\\> 8; urine glucose, ketones, protein, hemoglobin, nitrite and leukocyte esterase\\>=1. Number of participants with abnormalities in any of the laboratory parameters is reported.","populationDescription":"Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Up to week 28","groups":[{"id":"OG000","title":"Placebo (T2DM)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 20mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally."},{"id":"OG002","title":"PF-07081532 40mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally."},{"id":"OG003","title":"PF-07081532 80mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG004","title":"PF-07081532 160mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD 40 mg QD, 60 mg QD, 80 mg QD and 120 mg QD orally for 4 weeks, followed by PF-07081532 160 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD, 80 mg QD, 140 mg QD and 200 mg QD orally for 4 weeks, followed by PF-07081532 260 mg QD orally."},{"id":"OG006","title":"Rybelsus 14mg (T2DM)","description":"Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"73"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"72"},{"groupId":"OG004","value":"71"},{"groupId":"OG005","value":"73"},{"groupId":"OG006","value":"73"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"57"},{"groupId":"OG003","value":"57"},{"groupId":"OG004","value":"61"},{"groupId":"OG005","value":"59"},{"groupId":"OG006","value":"64"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Clinical Laboratory Abnormalities: Cohort 2 (Obesity)","description":"Hematology: platelets (10\\^9/L)\\< 0.5\\* LLN; leukocytes\\< 0.6\\*LLN and \\>1.5\\*ULN; lymphocytes and neutrophils \\<0.8\\*LLN and \\>1.2\\*ULN; basophils, eosinophils, monocytes:\\>1.2\\*ULN; prothrombin time (sec) \\>1.1\\*ULN; prothrombin international normalized ratio \\>1.1\\*ULN; clinical chemistry: bilirubin (mg/dL), indirect bilirubin:\\>1.5\\*ULN; aspartate and alanine aminotransferase, gamma glutamyl transferase (U/L):\\>3.0\\*ULN; urea nitrogen and creatinine (mg/dL)\\>1.3\\* ULN;HDL cholesterol (mg/dL)\\<0.8\\*LLN; LDL (mg/dL)\\>1.2\\*ULN, Triglycerides (mg/dL):\\>1.3\\*ULN; Potassium (milliequivalents per liter) \\< 0.9\\*LLN and \\> 1.1\\* ULN; calcium (mg/dL)\\< 0.9\\*LLN, Thyroxine (nanograms/dL\\<0.8\\*LLN and \\>1.2\\*ULN, HbA1C (%)\\>1.3\\*ULN; Amylase, Lipase (U/L) and Glucose -Fasting (mg/dL)\\>1.5\\*ULN; urinalysis: pH\\> 8; urine glucose, ketones, protein, hemoglobin, nitrite and leukocyte esterase\\>=1. Number of participants with abnormalities in any of the laboratory parameters is reported.","populationDescription":"Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Up to week 28","groups":[{"id":"OG000","title":"Placebo (Obesity)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 80mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG002","title":"PF-07081532 140mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD,120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally."},{"id":"OG003","title":"PF-07081532 200mg (Obesity,5 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD,160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG004","title":"PF-07081532 200mg (Obesity,4 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"63"},{"groupId":"OG003","value":"63"},{"groupId":"OG004","value":"66"},{"groupId":"OG005","value":"64"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"31"},{"groupId":"OG002","value":"40"},{"groupId":"OG003","value":"40"},{"groupId":"OG004","value":"48"},{"groupId":"OG005","value":"36"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With ECG Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)","description":"Standard 12-lead ECGs were performed after the participant had rested quietly for more than 10 minutes in a supine position utilizing an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QT interval corrected using Fridericia's formula (QTcF), and QRS complex. ECG abnormalities were categorized as: PR interval (milliseconds \\[msec\\]), Value \\>= 300; percent change (%Chg) greater than equal (\\>=) 25/50%. QRS duration (msec): Value \\>= 140 and %Chg \\>= 50%. QT interval (msec): Value \\> 500; QTCF interval (msec): 450 \\< Value \\<= 480, 480 \\< Value \\<= 500, Value \\> 500; 30 \\<= Change (Chg) \\<= 60; Chg \\> 60.","populationDescription":"Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Up to week 28","groups":[{"id":"OG000","title":"Placebo (T2DM)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 20mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally."},{"id":"OG002","title":"PF-07081532 40mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally."},{"id":"OG003","title":"PF-07081532 80mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG004","title":"PF-07081532 160mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD 40 mg QD, 60 mg QD, 80 mg QD and 120 mg QD orally for 4 weeks, followed by PF-07081532 160 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD, 80 mg QD, 140 mg QD and 200 mg QD orally for 4 weeks, followed by PF-07081532 260 mg QD orally."},{"id":"OG006","title":"Rybelsus 14mg (T2DM)","description":"Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"73"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"73"},{"groupId":"OG004","value":"72"},{"groupId":"OG005","value":"74"},{"groupId":"OG006","value":"73"}]}],"classes":[{"title":"PR Interval, (MSEC) value >=300","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"}]}]},{"title":"PR Interval, (MSEC) %Chg >= 25/50%","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"}]}]},{"title":"QRS duration, (MSEC) value >=140","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"3"}]}]},{"title":"QRS duration, (MSEC) %Chg >=50%","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"}]}]},{"title":"QT interval, single beat (MSEC) value > 500","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"}]}]},{"title":"QTCF interval, single beat (MSEC) 450 < Value <=480","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"5"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"5"}]}]},{"title":"QTCF interval, single beat (MSEC) 480 < Value <=500","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"1"}]}]},{"title":"QTCF interval, single beat (MSEC) Value > 500","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"}]}]},{"title":"QTCF interval, single beat (MSEC) 30 <= Chg <= 60","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"10"},{"groupId":"OG006","value":"8"}]}]},{"title":"QTCF interval, single beat (MSEC) Chg > 60","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With ECG Abnormalities: Cohort 2 (Obesity)","description":"Standard 12-lead ECGs were performed after the participant had rested quietly for more than 10 minutes in a supine position utilizing an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF, and QRS complex. ECG abnormalities were categorized as: PR interval msec, Value \\>= 300; percentage change (%Chg) \\>= 25/50%. QRS duration (msec): Value \\>= 140 and %Chg \\>= 50%. QT interval (msec): Value \\> 500; QTCF interval (msec): 450 \\< Value \\<= 480, 480 \\< Value \\<= 500, Value \\> 500; 30 \\<= Change (Chg) \\<= 60; Chg \\> 60.","populationDescription":"Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Up to week 28","groups":[{"id":"OG000","title":"Placebo (Obesity)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 80mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG002","title":"PF-07081532 140mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD,120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally."},{"id":"OG003","title":"PF-07081532 200mg (Obesity,5 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD,160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG004","title":"PF-07081532 200mg (Obesity,4 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"66"},{"groupId":"OG002","value":"64"},{"groupId":"OG003","value":"65"},{"groupId":"OG004","value":"66"},{"groupId":"OG005","value":"64"}]}],"classes":[{"title":"PR Interval, (MSEC) value >=300","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"}]}]},{"title":"PR Interval, (MSEC) %Chg >= 25/50%","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"}]}]},{"title":"QRS duration, (MSEC) value >=140","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]},{"title":"QRS duration, (MSEC) %Chg >=50%","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]},{"title":"QT interval, single beat (MSEC) value > 500","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]},{"title":"QTCF interval, single beat (MSEC) 450 < Value <=480","categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"7"}]}]},{"title":"QTCF interval, single beat (MSEC) 480 < Value <=500","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]},{"title":"QTCF interval, single beat (MSEC) Value > 500","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]},{"title":"QTCF interval, single beat (MSEC) 30 <= Chg <= 60","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"3"}]}]},{"title":"QTCF interval, single beat (MSEC) Chg > 60","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS) Category: Cohort 2 (Obesity) Only","description":"C-SSRS is an interview-based rating scale to assess suicidal ideation and suicidal behavior and had a binary response (yes/no). C-SSRS data was mapped to C-CASA per Guidance for Industry: Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials. A participant was said to have suicidal behavior in case of any of following events: 1) completed suicide; 2) suicide attempt; or 3) preparatory acts toward imminent suicidal behavior. A participant showed suicidal ideation if they responded 'yes' to any of the 5 questions, 'Wish to be dead; Non-Specific Active Suicidal Thoughts Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent. The participant was said to exhibit Self-injurious behavior, no suicidal intent if they responded as Yes to 'Has participant engaged in Non-suicidal Self-Injurious Behavior","populationDescription":"Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. This outcome measure was planned to be assessed in Cohort 2 only.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline (result closest prior to dosing on Day 1), anytime post-baseline (Up to Week 28)","groups":[{"id":"OG000","title":"Placebo (Obesity)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 80mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG002","title":"PF-07081532 140mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD,120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally."},{"id":"OG003","title":"PF-07081532 200mg (Obesity,5 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD,160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG004","title":"PF-07081532 200mg (Obesity,4 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"66"},{"groupId":"OG002","value":"64"},{"groupId":"OG003","value":"65"},{"groupId":"OG004","value":"66"},{"groupId":"OG005","value":"64"}]}],"classes":[{"title":"Baseline: <1> Completed suicide","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]},{"title":"Baseline: <2> Suicide attempt","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]},{"title":"Baseline: <3> Preparatory acts towards imminent suicidal behavior","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]},{"title":"Baseline: <4> Suicidal ideation","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"}]}]},{"title":"Baseline: <7> Self-injurious behavior, no suicidal intent","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]},{"title":"Post-Baseline: <1> Completed suicide","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]},{"title":"Post-Baseline: <2> Suicide attempt","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]},{"title":"Post-Baseline: <3> Preparatory acts towards imminent suicidal behavior","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]},{"title":"Post-Baseline: <4> Suicidal ideation","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"}]}]},{"title":"Post-Baseline: <7> Self-injurious behavior, no suicidal intent","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Placebo-adjusted, Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)","description":"Analysis was performed using mixed model repeated measures (MMRM) model including treatment, gender strata and time as fixed effects, baseline\\*time interaction, time\\*treatment interaction, and baseline as a covariate with time fitted as a repeated effect and participant as a random effect.","populationDescription":"Evaluable set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to randomized intervention. Here, \"Overall Number of Participants Analyzed\" refers to participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16","groups":[{"id":"OG000","title":"Placebo (T2DM)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 20mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally."},{"id":"OG002","title":"PF-07081532 40mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally."},{"id":"OG003","title":"PF-07081532 80mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG004","title":"PF-07081532 160mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD 40 mg QD, 60 mg QD, 80 mg QD and 120 mg QD orally for 4 weeks, followed by PF-07081532 160 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD, 80 mg QD, 140 mg QD and 200 mg QD orally for 4 weeks, followed by PF-07081532 260 mg QD orally."},{"id":"OG006","title":"Rybelsus 14mg (T2DM)","description":"Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"21"},{"groupId":"OG003","value":"22"},{"groupId":"OG004","value":"25"},{"groupId":"OG005","value":"21"},{"groupId":"OG006","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.07","spread":"0.109"},{"groupId":"OG001","value":"-1.03","spread":"0.106"},{"groupId":"OG002","value":"-1.37","spread":"0.112"},{"groupId":"OG003","value":"-1.44","spread":"0.111"},{"groupId":"OG004","value":"-1.34","spread":"0.110"},{"groupId":"OG005","value":"-1.36","spread":"0.114"},{"groupId":"OG006","value":"-0.94","spread":"0.109"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"<.0001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-0.95","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.20","ciUpperLimit":"-0.70"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"OTHER","pValue":"<.0001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-1.30","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.55","ciUpperLimit":"-1.04"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"OTHER","pValue":"<.0001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-1.37","ciPctValue":"90","ciLowerLimit":"-1.62","ciUpperLimit":"-1.11"},{"groupIds":["OG000","OG004"],"nonInferiorityType":"OTHER","pValue":"<.0001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-1.26","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.52","ciUpperLimit":"-1.01"},{"groupIds":["OG000","OG005"],"nonInferiorityType":"OTHER","pValue":"<.0001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-1.29","ciPctValue":"90","ciLowerLimit":"-1.55","ciUpperLimit":"-1.03"},{"groupIds":["OG000","OG006"],"nonInferiorityType":"OTHER","pValue":"<.0001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-0.86","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.12","ciUpperLimit":"-0.61"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Placebo-adjusted, Percent Change From Baseline in Body Weight at Week 20: Cohort 2 (Obesity)","description":"Body weight was measured using a calibrated weighing scale. Analysis was performed using MMRM model including treatment, gender strata and time as fixed effects, baseline\\*time interaction, time\\*treatment interaction, and baseline as a covariate with time fitted as a repeated effect and participant as a random effect.","populationDescription":"Evaluable set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to randomized intervention. Here, \"Overall Number of Participants Analyzed\" refers to participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percent change","timeFrame":"Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 20","groups":[{"id":"OG000","title":"Placebo (Obesity)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 80mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG002","title":"PF-07081532 140mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD,120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally."},{"id":"OG003","title":"PF-07081532 200mg (Obesity,5 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD,160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG004","title":"PF-07081532 200mg (Obesity,4 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"44"},{"groupId":"OG002","value":"37"},{"groupId":"OG003","value":"38"},{"groupId":"OG004","value":"31"},{"groupId":"OG005","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.84","spread":"0.612"},{"groupId":"OG001","value":"-4.28","spread":"0.623"},{"groupId":"OG002","value":"-6.21","spread":"0.654"},{"groupId":"OG003","value":"-7.47","spread":"0.628"},{"groupId":"OG004","value":"-6.88","spread":"0.638"},{"groupId":"OG005","value":"-7.26","spread":"0.664"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.0055","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-2.44","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.88","ciUpperLimit":"-1.00"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"OTHER","pValue":"<.0001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-4.37","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.84","ciUpperLimit":"-2.89"},{"groupIds":["OG000","OG003"],"nonInferiorityType":"OTHER","pValue":"<.0001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-5.63","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.07","ciUpperLimit":"-4.18"},{"groupIds":["OG000","OG004"],"nonInferiorityType":"OTHER","pValue":"<.0001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-5.04","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.50","ciUpperLimit":"-3.58"},{"groupIds":["OG000","OG005"],"nonInferiorityType":"OTHER","pValue":"<.0001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-5.42","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.91","ciUpperLimit":"-3.93"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)","populationDescription":"Evaluable set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to randomized intervention. Here, \"Number of Participants Analyzed\" refers to participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Milligrams per deciliter","timeFrame":"Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16","groups":[{"id":"OG000","title":"Placebo (T2DM)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 20mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally."},{"id":"OG002","title":"PF-07081532 40mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally."},{"id":"OG003","title":"PF-07081532 80mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG004","title":"PF-07081532 160mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD 40 mg QD, 60 mg QD, 80 mg QD and 120 mg QD orally for 4 weeks, followed by PF-07081532 160 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD, 80 mg QD, 140 mg QD and 200 mg QD orally for 4 weeks, followed by PF-07081532 260 mg QD orally."},{"id":"OG006","title":"Rybelsus 14mg (T2DM)","description":"Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"21"},{"groupId":"OG003","value":"22"},{"groupId":"OG004","value":"25"},{"groupId":"OG005","value":"21"},{"groupId":"OG006","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"160.70","spread":"39.595"},{"groupId":"OG001","value":"135.59","spread":"31.746"},{"groupId":"OG002","value":"127.00","spread":"35.928"},{"groupId":"OG003","value":"132.19","spread":"31.541"},{"groupId":"OG004","value":"127.65","spread":"28.839"},{"groupId":"OG005","value":"125.07","spread":"46.924"},{"groupId":"OG006","value":"130.06","spread":"28.120"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Percent Change From Baseline in Body Weight at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)","description":"Body weight was measured using a calibrated weighing scale.","populationDescription":"Evaluable set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to randomized intervention. Here, \"Number of Participants Analyzed\" refers to participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percent change","timeFrame":"Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16","groups":[{"id":"OG000","title":"Placebo (T2DM)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 20mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally."},{"id":"OG002","title":"PF-07081532 40mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally."},{"id":"OG003","title":"PF-07081532 80mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG004","title":"PF-07081532 160mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD 40 mg QD, 60 mg QD, 80 mg QD and 120 mg QD orally for 4 weeks, followed by PF-07081532 160 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD, 80 mg QD, 140 mg QD and 200 mg QD orally for 4 weeks, followed by PF-07081532 260 mg QD orally."},{"id":"OG006","title":"Rybelsus 14mg (T2DM)","description":"Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"32"},{"groupId":"OG002","value":"30"},{"groupId":"OG003","value":"28"},{"groupId":"OG004","value":"28"},{"groupId":"OG005","value":"30"},{"groupId":"OG006","value":"27"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"93.164","spread":"22.0659"},{"groupId":"OG001","value":"86.251","spread":"17.3464"},{"groupId":"OG002","value":"91.556","spread":"23.4071"},{"groupId":"OG003","value":"92.979","spread":"24.5045"},{"groupId":"OG004","value":"85.564","spread":"17.9582"},{"groupId":"OG005","value":"87.658","spread":"21.6950"},{"groupId":"OG006","value":"91.799","spread":"20.4605"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Placebo-adjusted, Change From Baseline in Percentage of HbA1C in the Rybelsus Arm Versus Placebo Arm at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)","description":"Analysis was performed using MMRM model including treatment, gender strata and time as fixed effects, baseline\\*time interaction, time\\*treatment interaction, and baseline as a covariate with time fitted as a repeated effect and participant as a random effect. This outcome measure was planned to be analyzed only for rybelsus arm and placebo arm as pre-specified in the protocol.","populationDescription":"Evaluable set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to randomized intervention.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage of HbA1C","timeFrame":"Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16","groups":[{"id":"OG000","title":"Rybelsus 14mg (T2DM)","description":"Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD."},{"id":"OG001","title":"Placebo (T2DM)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.94","spread":"0.109"},{"groupId":"OG001","value":"-0.07","spread":"0.109"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"<.0001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-0.86","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.12","ciUpperLimit":"-0.61"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Absolute Change From Baseline in Waist Circumference at Week 12 and 24: Cohort 2 (Obesity)","description":"Waist circumference was measured at midpoint, between lower margin of last palpable rib and top of iliac crest (approximately 1 inch \\[2.54 cm\\] above the navel). It was measured by using an anthropometric tape (stretch-resistant).","populationDescription":"Evaluable set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to randomized intervention. Here \"Number Analyzed\" refers to the number of participants evaluable for the specified rows.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Centimeter","timeFrame":"Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], Week 12, 24","groups":[{"id":"OG000","title":"Placebo (Obesity)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 80mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG002","title":"PF-07081532 140mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD,120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally."},{"id":"OG003","title":"PF-07081532 200mg (Obesity,5 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD,160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG004","title":"PF-07081532 200mg (Obesity,4 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"49"},{"groupId":"OG003","value":"56"},{"groupId":"OG004","value":"53"},{"groupId":"OG005","value":"50"}]}],"classes":[{"title":"Week 12","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"49"},{"groupId":"OG003","value":"56"},{"groupId":"OG004","value":"53"},{"groupId":"OG005","value":"50"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.702","spread":"4.1726"},{"groupId":"OG001","value":"-2.574","spread":"5.0872"},{"groupId":"OG002","value":"-3.017","spread":"5.9117"},{"groupId":"OG003","value":"-3.559","spread":"6.5122"},{"groupId":"OG004","value":"-2.191","spread":"5.2942"},{"groupId":"OG005","value":"-1.079","spread":"4.6710"}]}]},{"title":"Week 24","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"7"},{"groupId":"OG005","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-4.233","spread":"5.3953"},{"groupId":"OG001","value":"-5.147","spread":"4.1807"},{"groupId":"OG002","value":"-6.314","spread":"10.2170"},{"groupId":"OG003","value":"-2.722","spread":"7.6706"},{"groupId":"OG004","value":"-10.297","spread":"7.7652"},{"groupId":"OG005","value":"-6.450","spread":"4.2123"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Absolute Change From Baseline in Waist-to-hip Ratio at Week 12 and Week 24: Cohort 2 (Obesity)","description":"The hip circumference was defined as the circumference around the widest portion of the buttocks. Waist circumference was measured at midpoint, between lower margin of last palpable rib and top of iliac crest (approximately 1 inch \\[2.54 cm\\] above the navel). The measurements were performed using an anthropometric tape (stretch-resistant).","populationDescription":"Evaluable set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to randomized intervention. Here \"Number Analyzed\" refers to the number of participants evaluable for the specified rows.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Ratio","timeFrame":"Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], week 12, 24","groups":[{"id":"OG000","title":"Placebo (Obesity)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 80mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG002","title":"PF-07081532 140mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD,120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally."},{"id":"OG003","title":"PF-07081532 200mg (Obesity,5 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD,160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG004","title":"PF-07081532 200mg (Obesity,4 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"49"},{"groupId":"OG003","value":"56"},{"groupId":"OG004","value":"53"},{"groupId":"OG005","value":"50"}]}],"classes":[{"title":"Week 12","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"49"},{"groupId":"OG003","value":"56"},{"groupId":"OG004","value":"53"},{"groupId":"OG005","value":"50"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.013","spread":"0.0374"},{"groupId":"OG001","value":"-0.002","spread":"0.0459"},{"groupId":"OG002","value":"-0.006","spread":"0.0578"},{"groupId":"OG003","value":"-0.010","spread":"0.0683"},{"groupId":"OG004","value":"-0.002","spread":"0.0423"},{"groupId":"OG005","value":"0.015","spread":"0.0557"}]}]},{"title":"Week 24","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"7"},{"groupId":"OG005","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.023","spread":"0.0419"},{"groupId":"OG001","value":"-0.017","spread":"0.0250"},{"groupId":"OG002","value":"-0.032","spread":"0.0588"},{"groupId":"OG003","value":"0.018","spread":"0.0563"},{"groupId":"OG004","value":"-0.009","spread":"0.0498"},{"groupId":"OG005","value":"-0.037","spread":"0.0574"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 16: Cohort 2 (Obesity)","description":"HOMA-IR was calculated as: (\\[FPI\\]\\*(FPG)/405 in terms of Mg/dL\\* (milliunits per liter).","populationDescription":"Evaluable set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to randomized intervention. Here, \"Number of Participants Analyzed\" refers to participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Milliunits per liter","timeFrame":"Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16","groups":[{"id":"OG000","title":"Placebo (Obesity)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 80mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG002","title":"PF-07081532 140mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD,120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally."},{"id":"OG003","title":"PF-07081532 200mg (Obesity,5 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD,160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG004","title":"PF-07081532 200mg (Obesity,4 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"48"},{"groupId":"OG002","value":"42"},{"groupId":"OG003","value":"46"},{"groupId":"OG004","value":"42"},{"groupId":"OG005","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.630","spread":"2.1753"},{"groupId":"OG001","value":"0.185","spread":"2.0579"},{"groupId":"OG002","value":"-0.121","spread":"4.7540"},{"groupId":"OG003","value":"0.984","spread":"3.9090"},{"groupId":"OG004","value":"-1.172","spread":"2.7360"},{"groupId":"OG005","value":"-0.210","spread":"1.1373"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Change From Baseline in Homeostatic Model Assessment for Insulin Sensitivity (HOMA-S) at Week 16: Cohort 2 (Obesity)","description":"HOMA-S was calculated as (22.5/\\[FPI\\]\\*FPG)) \\*100 and measured in terms of. percentage sensitivity.","populationDescription":"Evaluable set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to randomized intervention. Here, \"Number of Participants Analyzed\" refers to participants evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage sensitivity","timeFrame":"Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16","groups":[{"id":"OG000","title":"Placebo (Obesity)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally."},{"id":"OG001","title":"PF-07081532 80mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally."},{"id":"OG002","title":"PF-07081532 140mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD,120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally."},{"id":"OG003","title":"PF-07081532 200mg (Obesity,5 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD,160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG004","title":"PF-07081532 200mg (Obesity,4 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally."},{"id":"OG005","title":"PF-07081532 260mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"48"},{"groupId":"OG002","value":"42"},{"groupId":"OG003","value":"46"},{"groupId":"OG004","value":"42"},{"groupId":"OG005","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.419","spread":"51.8526"},{"groupId":"OG001","value":"1.594","spread":"24.1848"},{"groupId":"OG002","value":"7.807","spread":"26.5041"},{"groupId":"OG003","value":"-7.085","spread":"21.6406"},{"groupId":"OG004","value":"3.497","spread":"68.2570"},{"groupId":"OG005","value":"-2.045","spread":"28.8973"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"2","timeFrame":"Part1 and 2: From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)","description":"Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.","eventGroups":[{"id":"EG000","title":"Placebo (T2DM)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.","deathsNumAffected":1,"deathsNumAtRisk":75,"seriousNumAffected":1,"seriousNumAtRisk":75,"otherNumAffected":23,"otherNumAtRisk":75},{"id":"EG001","title":"PF-07081532 20mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally.","deathsNumAffected":0,"deathsNumAtRisk":73,"seriousNumAffected":0,"seriousNumAtRisk":73,"otherNumAffected":31,"otherNumAtRisk":73},{"id":"EG002","title":"PF-07081532 40mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally.","deathsNumAffected":0,"deathsNumAtRisk":72,"seriousNumAffected":3,"seriousNumAtRisk":72,"otherNumAffected":46,"otherNumAtRisk":72},{"id":"EG003","title":"PF-07081532 80mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally.","deathsNumAffected":0,"deathsNumAtRisk":73,"seriousNumAffected":3,"seriousNumAtRisk":73,"otherNumAffected":37,"otherNumAtRisk":73},{"id":"EG004","title":"PF-07081532 160mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD 40 mg QD, 60 mg QD, 80 mg QD and 120 mg QD orally for 4 weeks, followed by PF-07081532 160 mg QD orally.","deathsNumAffected":0,"deathsNumAtRisk":72,"seriousNumAffected":1,"seriousNumAtRisk":72,"otherNumAffected":41,"otherNumAtRisk":72},{"id":"EG005","title":"PF-07081532 260mg (T2DM)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD, 80 mg QD, 140 mg QD and 200 mg QD orally for 4 weeks, followed by PF-07081532 260 mg QD orally.","deathsNumAffected":0,"deathsNumAtRisk":74,"seriousNumAffected":2,"seriousNumAtRisk":74,"otherNumAffected":51,"otherNumAtRisk":74},{"id":"EG006","title":"Rybelsus 14mg (T2DM)","description":"Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.","deathsNumAffected":0,"deathsNumAtRisk":73,"seriousNumAffected":1,"seriousNumAtRisk":73,"otherNumAffected":32,"otherNumAtRisk":73},{"id":"EG007","title":"Placebo (Obesity)","description":"Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.","deathsNumAffected":0,"deathsNumAtRisk":64,"seriousNumAffected":1,"seriousNumAtRisk":64,"otherNumAffected":42,"otherNumAtRisk":64},{"id":"EG008","title":"PF-07081532 80mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally.","deathsNumAffected":0,"deathsNumAtRisk":66,"seriousNumAffected":2,"seriousNumAtRisk":66,"otherNumAffected":50,"otherNumAtRisk":66},{"id":"EG009","title":"PF-07081532 140mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD,120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally.","deathsNumAffected":0,"deathsNumAtRisk":64,"seriousNumAffected":2,"seriousNumAtRisk":64,"otherNumAffected":48,"otherNumAtRisk":64},{"id":"EG010","title":"PF-07081532 200mg (Obesity,5 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD,160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally.","deathsNumAffected":0,"deathsNumAtRisk":65,"seriousNumAffected":1,"seriousNumAtRisk":65,"otherNumAffected":55,"otherNumAtRisk":65},{"id":"EG011","title":"PF-07081532 200mg (Obesity,4 Steps)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally.","deathsNumAffected":0,"deathsNumAtRisk":66,"seriousNumAffected":2,"seriousNumAtRisk":66,"otherNumAffected":59,"otherNumAtRisk":66},{"id":"EG012","title":"PF-07081532 260mg (Obesity)","description":"Participants randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally.","deathsNumAffected":0,"deathsNumAtRisk":64,"seriousNumAffected":2,"seriousNumAtRisk":64,"otherNumAffected":53,"otherNumAtRisk":64}],"seriousEvents":[{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v26.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":75},{"groupId":"EG001","numAffected":0,"numAtRisk":73},{"groupId":"EG002","numAffected":0,"numAtRisk":72},{"groupId":"EG003","numAffected":0,"numAtRisk":73},{"groupId":"EG004","numAffected":0,"numAtRisk":72},{"groupId":"EG005","numAffected":0,"numAtRisk":74},{"groupId":"EG006","numAffected":0,"numAtRisk":73},{"groupId":"EG007","numAffected":0,"numAtRisk":64},{"groupId":"EG008","numAffected":0,"numAtRisk":66},{"groupId":"EG009","numAffected":1,"numAtRisk":64},{"groupId":"EG010","numAffected":0,"numAtRisk":65},{"groupId":"EG011","numAffected":0,"numAtRisk":66},{"groupId":"EG012","numAffected":0,"numAtRisk":64}]},{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v26.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":75},{"groupId":"EG001","numAffected":0,"numAtRisk":73},{"groupId":"EG002","numAffected":0,"numAtRisk":72},{"groupId":"EG003","numAffected":0,"numAtRisk":73},{"groupId":"EG004","numAffected":0,"numAtRisk":72},{"groupId":"EG005","numAffected":0,"numAtRisk":74},{"groupId":"EG006","numAffected":0,"numAtRisk":73},{"groupId":"EG007","numAffected":1,"numAtRisk":64},{"groupId":"EG008","numAffected":0,"numAtRisk":66},{"groupId":"EG009","numAffected":0,"numAtRisk":64},{"groupId":"EG010","numAffected":0,"numAtRisk":65},{"groupId":"EG011","numAffected":0,"numAtRisk":66},{"groupId":"EG012","numAffected":0,"numAtRisk":64}]},{"term":"Hypertransaminasaemia","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA v26.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":75},{"groupId":"EG001","numAffected":0,"numAtRisk":73},{"groupId":"EG002","numAffected":0,"numAtRisk":72},{"groupId":"EG003","numAffected":0,"numAtRisk":73},{"groupId":"EG004","numAffected":1,"numAtRisk":72},{"groupId":"EG005","numAffected":0,"numAtRisk":74},{"groupId":"EG006","numAffected":0,"numAtRisk":73},{"groupId":"EG007","numAffected":0,"numAtRisk":64},{"groupId":"EG008","numAffected":1,"numAtRisk":66},{"groupId":"EG009","numAffected":0,"numAtRisk":64},{"groupId":"EG010","numAffected":0,"numAtRisk":65},{"groupId":"EG011","numAffected":1,"numAtRisk":66},{"groupId":"EG012","numAffected":0,"numAtRisk":64}]},{"term":"COVID-19 pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 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