Trial to Learn About the Study Medicine (PF-07081532) and... | NCT05579977 | Trialant
NCT05579977
Sponsor
Pfizer
Status
Terminated
Last Update Posted
Aug 1, 2024Actual
Enrollment
902Actual
Phase
Phase 2
Conditions
Diabetes Mellitus
Obesity
Interventions
PF-07081532
Placebo
Rybelsus
Countries
United States
Bulgaria
Canada
Czechia
Hungary
Japan
Poland
Puerto Rico
Protocol Section
Identification Module
NCT ID
NCT05579977
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C3991004
Secondary IDs
ID
Type
Description
Link
2022-002834-15
EudraCT Number
Brief Title
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
Official Title
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
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Jul 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
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.
Expanded Access Info
No
Start Date
Oct 27, 2022Actual
Primary Completion Date
Jul 14, 2023Actual
Completion Date
Sep 22, 2023Actual
First Submitted Date
Oct 11, 2022
First Submission Date that Met QC Criteria
Oct 11, 2022
First Posted Date
Oct 14, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Jul 9, 2024
Results First Submitted that Met QC Criteria
Jul 9, 2024
Results First Posted Date
Aug 1, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 9, 2024
Last Update Posted Date
Aug 1, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
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.
Those 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.
Detailed Description
Not provided
Conditions Module
Conditions
Diabetes Mellitus
Obesity
Keywords
Diabetes Mellitus
Obesity
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
902Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
PF-07081532 20 mg T2DM
Experimental
PF-07081532 20 mg daily in T2DM
Drug: PF-07081532
PF-07081532 40 mg T2DM
Experimental
PF-07081532 40 mg daily in T2DM
Drug: PF-07081532
PF-07081532 80 mg T2DM
Experimental
PF-07081532 80 mg daily in T2DM
Drug: PF-07081532
PF-07081532 160 mg T2DM
Experimental
PF-07081532 160 mg daily in T2DM
Drug: PF-07081532
PF-07081532 260 mg T2DM
Experimental
PF-07081532 260 mg daily in T2DM
Drug: PF-07081532
Placebo T2DM
Placebo Comparator
Placebo daily in T2DM
Other: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-07081532
Drug
Oral glucagon-like peptide-1 receptor agonist
PF-07081532 140 mg Obesity
PF-07081532 160 mg T2DM
PF-07081532 20 mg T2DM
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Placebo-adjusted, Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)
Baseline (result closest prior to dosing on Day 1), Week 32
Placebo-adjusted, Percent Change From Baseline in Body Weight at Week 32: Cohort 2 (Obesity)
Body weight was measured using a calibrated weighing scale.
Baseline (result closest prior to dosing on Day 1), week 32
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Achieved HbA1C <7% at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)
Baseline (result closest prior to dosing on Day 1), Week 32
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)
Other Outcomes
Measure
Description
Time Frame
Placebo-adjusted, Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)
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.
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
T2DM
T2DM inadequately controlled with metformin
BMI ≥23.0 kg/m2 (≥20.0 kg/m2 in Japan)
HbA1C of 7% to 10% (53-86 mmol/mol)
FPG ≤270 mg/dL (15 mmol/L)
Obesity
BMI ≥30.0 kg/m2
HbA1C ≤6.4% (47 mmol/mol)
FPG ≤126 mg/dL (7 mmol/L)
Exclusion Criteria:
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)
Use of pharmacological agents with approved indication for weight loss
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;
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
Clinically significant cardiovascular conditions
Uncontrolled blood pressure
Personal or within first-degree relative family history of MTC or MEN2
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
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
Kokkorakis M, Chakhtoura M, Rhayem C, Al Rifai J, Ghezzawi M, Valenzuela-Vallejo L, Mantzoros CS. Emerging pharmacotherapies for obesity: A systematic review. Pharmacol Rev. 2025 Jan;77(1):100002. doi: 10.1124/pharmrev.123.001045. Epub 2024 Nov 22.
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.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
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.
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.
Recruitment Details
This study had 2 cohorts: Cohort 1 included participants with type 2 diabetes mellitus (T2DM) on a background therapy of metformin. Cohort 2 included participants with obesity but without T2DM.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo (T2DM)
Participants randomized to receive a single dose of PF-07081532-matching placebo once daily (QD) orally.
FG001
PF-07081532 20mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally.
Baseline (result closest prior to dosing on Day 1), Week 32
Percent Change From Baseline in Body Weight at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)
Body weight was measured using a calibrated weighing scale.
Baseline (result closest prior to dosing on Day 1), Week 32
Placebo-adjusted, Change From Baseline in HbA1C in the Rybelsus Arm at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)
This outcome measure was planned to be analyzed only for rybelsus arm and placebo arm as pre-specified in the protocol.
Baseline (result closest prior to dosing on Day 1), Week 32
Percentage of Participants Achieving >=5%, >=10%, and >=15% Body Weight Loss at Week 32 Relative to Baseline: Cohort 2 (Obesity)
Baseline (result closest prior to dosing on Day 1), Week 32
Absolute Change From Baseline in Waist Circumference at Week 32: Cohort 2 (Obesity)
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).
Baseline (result closest prior to dosing on Day 1), Week 32
Absolute Change From Baseline in Waist-to-hip Ratio at Week 32: Cohort 2 (Obesity)
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).
Baseline (result closest prior to dosing on Day 1), Week 32
Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 32: Cohort 2 (Obesity)
HOMA-IR was calculated as: fasting plasma insulin ([FPI]*(FPG)/405 and measured in terms of mg/dL* (milliunits per liter).
Baseline (result closest prior to dosing on Day 1), Week 32
Change From Baseline in Homeostatic Model Assessment for Insulin Sensitivity (HOMA-S) at Week 32: Cohort 2 (Obesity)
HOMA-S was calculated as (22.5/[FPI] * FPG) *100 and measured in terms of percentage sensitivity.
Baseline (result closest prior to dosing on Day 1), Week 32
Number of Participants With Treatment Emergent Adverse Events (TEAEs): Cohort 1 (Type 2 Diabetes Mellitus)
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.
From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
Number of Participants With Treatment Emergent Adverse Events (TEAEs): Cohort 2 (Obesity)
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.
From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
Number of Participants With Serious Adverse Events (SAEs): Cohort 1 (Type 2 Diabetes Mellitus)
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.
From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
Number of Participants With Serious Adverse Events (SAEs): Cohort 2 (Obesity)
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.
From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
Number of Participants Reporting Adverse Events Leading to Permanent Discontinuation From Study Treatment and Study: Cohort 1 (Type 2 Diabetes Mellitus)
\ 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.
From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
Number of Participants Reporting Adverse Events Leading to Permanent Discontinuation From Study Treatment and Study: Cohort 2 (Obesity)
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.
From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
Number of Participants With Hypoglycemic Adverse Events (HAE) According to Titration Dose: Cohort 1 (Type 2 Diabetes Mellitus)
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.
Up to week 28
Number of Participants With Hypoglycemic Adverse Events According to Titration Dose: Cohort 2 (Obesity)
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.
Up to week 28
Number of Participants With Vital Sign Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)
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.
Up to week 28
Number of Participants With Vital Sign Abnormalities: Cohort 2 (Obesity)
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.
Up to week 28
Number of Participants With Clinical Laboratory Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)
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.
Up to week 28
Number of Participants With Clinical Laboratory Abnormalities: Cohort 2 (Obesity)
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.
Up to week 28
Number of Participants With ECG Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)
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.
Up to week 28
Number of Participants With ECG Abnormalities: Cohort 2 (Obesity)
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.
Up to week 28
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS) Category: Cohort 2 (Obesity) Only
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
Baseline (result closest prior to dosing on Day 1), anytime post-baseline (Up to Week 28)
Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16
Placebo-adjusted, Percent Change From Baseline in Body Weight at Week 20: Cohort 2 (Obesity)
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.
Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 20
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)
Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16
Percent Change From Baseline in Body Weight at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)
Body weight was measured using a calibrated weighing scale.
Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16
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)
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.
Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16
Absolute Change From Baseline in Waist Circumference at Week 12 and 24: Cohort 2 (Obesity)
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).
Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], Week 12, 24
Absolute Change From Baseline in Waist-to-hip Ratio at Week 12 and Week 24: Cohort 2 (Obesity)
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).
Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], week 12, 24
Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 16: Cohort 2 (Obesity)
HOMA-IR was calculated as: ([FPI]*(FPG)/405 in terms of Mg/dL* (milliunits per liter).
Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16
Change From Baseline in Homeostatic Model Assessment for Insulin Sensitivity (HOMA-S) at Week 16: Cohort 2 (Obesity)
HOMA-S was calculated as (22.5/[FPI]*FPG)) *100 and measured in terms of. percentage sensitivity.
Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16
Anaheim
California
92801
United States
San Fernando Valley Health Institute
Canoga Park
California
91304
United States
Catalina Research Institute, LLC
Montclair
California
91763
United States
Empire Clinical Research
Pomona
California
91767
United States
University Clinical Investigators, Inc.
Tustin
California
92780
United States
Diablo Clinical Research, Inc.
Walnut Creek
California
94598
United States
Innovative Research of West Florida
Clearwater
Florida
33756
United States
Jacksonville Center for Clinical Research
Jacksonville
Florida
32216
United States
Adult Medicine of Lake County
Mt. Dora
Florida
32757
United States
Endocrine Research Solutions, Inc.
Roswell
Georgia
30076
United States
Cedar Crosse Research Center
Chicago
Illinois
60607
United States
Evanston Premier Healthcare Research LLC
Skokie
Illinois
60077
United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines
Iowa
50265
United States
Anderson Medical Research
Ft. Washington
Maryland
20744
United States
StudyMetrix Research
City of Saint Peters
Missouri
63303
United States
Mercury Street Medical Group, PLLC
Butte
Montana
59701
United States
Hassman Research Institute
Berlin
New Jersey
08009
United States
Premier Research
Trenton
New Jersey
08611
United States
Medication Management
Greensboro
North Carolina
27405
United States
Meridian Clinical Research, LLC
Cincinnati
Ohio
45219
United States
Alliance for Multispecialty Research, LLC
Norman
Oklahoma
73069
United States
Heritage Valley Multispecialty Group, Inc
Beaver
Pennsylvania
15009
United States
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
Pittsburgh
Pennsylvania
15236
United States
Preferred Primary Care Physicians
Uniontown
Pennsylvania
15401
United States
Velocity Clinical Research, Providence
East Greenwich
Rhode Island
02818
United States
HealthStar Physicians, P.C.
Morristown
Tennessee
37813
United States
Healthstar Physicians
Morristown
Tennessee
37813
United States
Elligo Clinical Research Center
Austin
Texas
78738
United States
Velocity Clinical Research, Dallas
Dallas
Texas
75230
United States
UT Southwestern Medical Center
Dallas
Texas
75390
United States
Medical Colleagues of Texas, LLP
Katy
Texas
77450
United States
Tapia Internal Medicine Clinic
Paris
Texas
75462
United States
Northeast Clinical Research of San Antonio
San Antonio
Texas
78233
United States
Consano Clinical Research, LLC
Shavano Park
Texas
78231
United States
Sugar Lakes Family Practice
Sugar Land
Texas
77479
United States
Chrysalis Clinical Research
St. George
Utah
84790
United States
Southwest Internal Medicine
St. George
Utah
84790
United States
Manassas Clinical Research Center
Manassas
Virginia
20110
United States
Medical Centre "Asklepiy"
Dupnitsa
Kyustendil
2600
Bulgaria
MHAT Botevgrad
Botevgrad
Sofia
2140
Bulgaria
Diagnostic Consultative Center Aleksandrovska
Sofia
Sofia (stolitsa)
1431
Bulgaria
Medical Center Zdrave 1
Kozloduy
Vratsa
3320
Bulgaria
"Prevencia - 2000 - Medical Center for Prehospital Medical Care" OOD
Stara Zagora
6000
Bulgaria
Dr. M.B. Jones Inc.
Victoria
British Columbia
V8V 4A1
Canada
G A Research Associates
Moncton
New Brunswick
E1G 1A7
Canada
Aggarwal and Associates Limited
Brampton
Ontario
L6T 0G1
Canada
Dawson Clinical Research
Guelph
Ontario
N1H 1B1
Canada
Milestone Research Inc.
London
Ontario
N5W 6A2
Canada
Bluewater Clinical Research Group Inc.
Sarnia
Ontario
N7T 4X3
Canada
LMC Clinical Research Inc. (Bayview)
Toronto
Ontario
M4G 3E8
Canada
Manna Research Mirabel
Mirabel
Quebec
J7J 2K8
Canada
Diex Recherche Victoriavile Inc.
Victoriaville
Quebec
G6P 6P6
Canada
Diex Recherche Quebec Inc.
Québec
G1V 4T3
Canada
Centre de Recherche Saint-Louis
Québec
G1W 4R4
Canada
EDUMED s.r.o.
Broumov
Kralovehradecky KRAY
550 01
Czechia
Kardiologicka a Angiologicka Ambulance
Ostrava
Ostrava Město
700 30
Czechia
MUDr. Alena Vachova
České Budějovice
South Bohemian Region
37011
Czechia
Clinical Trials Service s.r.o.
Uherské Hradiště
Zlín
686 01
Czechia
Agentura Science Pro
Olomouc
779 00
Czechia
Private Practice - Dr. Tomáš Brychta
Olomouc
779 00
Czechia
EUC Klinika Praha
Prague
150 00
Czechia
Clinical Trials Service s.r.o.
Uherské Hradiště
Czechia
Belinus Orvosi és Számitástechnikai Bt
Debrecen
Hajdú-Bihar
4025
Hungary
Borbánya Praxis
Nyíregyháza, Borbánya
Szabolcs-Szatmár-Bereg
4405
Hungary
CLINFAN Szolgáltató Kft
Szekszárd
Tolna County
7100
Hungary
DRC Gyógyszervizsgáló Központ
Balatonfüred
Veszprém megye
8230
Hungary
ClinDiab Kft.
Budapest
1089
Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen
04032
Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen
4032
Hungary
Nakakinen clinic
Naka
Ibaraki
311-0113
Japan
Yokohama Minoru Clinic
Yokohama
Kanagawa
232-0064
Japan
Shiraiwa Medical Clinic
Kashihara
Osaka
582-0005
Japan
Medical Corporation Heishinkai OCROM Clinic
Suita-shi
Osaka
565-0853
Japan
Seiwa Clinic
Adachi-ku
Tokyo
120-0011
Japan
Seiwa Clinic
Adachi-ku
Tokyo
123-0845
Japan
Tokyo-Eki Center-building Clinic
Chuo-ku
Tokyo
103-0027
Japan
Medical Corporation Chiseikai Tokyo Center Clinic
Chuo-ku
Tokyo
103-0028
Japan
Fukuwa Clinic
Chuo-ku
Tokyo
104-0031
Japan
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku
Tokyo
160-0008
Japan
Yokohama Minoru Clinic
Yokohama
232-0064
Japan
Oświęcimskie Centrum Badań Klinicznych
Oświęcim
Lesser Poland Voivodeship
32-600
Poland
KO-MED Centra Kliniczne Pulawy
Puławy
Lublin Voivodeship
24-100
Poland
Zdrowie Osteo-Medic
Bialystok
Podlaskie Voivodeship
15-351
Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk
Pomeranian Voivodeship
80-546
Poland
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally.
FG003
PF-07081532 80mg (T2DM)
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.
FG004
PF-07081532 160mg (T2DM)
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.
FG005
PF-07081532 260mg (T2DM)
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.
FG006
Rybelsus 14mg (T2DM)
Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.
FG007
Placebo (Obesity)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
FG008
PF-07081532 80mg (Obesity)
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.
FG009
PF-07081532 140mg (Obesity)
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.
FG010
PF-07081532 200mg (Obesity,5 Steps)
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.
FG011
PF-07081532 200mg (Obesity,4 Steps)
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.
FG012
PF-07081532 260mg (Obesity)
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.
FG00075 subjects
FG00173 subjects
FG00272 subjects
FG00373 subjects
FG00473 subjects
FG00574 subjects
FG00673 subjects
FG00764 subjects
FG00866 subjects
FG00964 subjects
FG01065 subjects
FG01166 subjects
FG01264 subjects
Received Treatment
FG00075 subjects
FG00173 subjects
FG00272 subjects
FG00373 subjects
FG00472 subjects
FG00574 subjects
FG00673 subjects
FG00764 subjects
FG00866 subjects
FG00964 subjects
FG01065 subjects
FG01166 subjects
FG01264 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
NOT COMPLETED
FG00075 subjects
FG00173 subjects
FG00272 subjects
FG00373 subjects
FG00473 subjects
FG00574 subjects
FG00673 subjects
FG00764 subjects
FG00866 subjects
FG00964 subjects
FG01065 subjects
FG01166 subjects
FG01264 subjects
Type
Comment
Reasons
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0041 subjects
FG0052 subjects
FG0061 subjects
FG0072 subjects
FG0082 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0123 subjects
Treatment with restricted medication needed
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Study terminated by sponsor
FG00070 subjects
FG00170 subjects
FG00261 subjects
FG00359 subjects
FG004
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0013 subjects
FG00211 subjects
FG00310 subjects
FG004
Randomized not treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Follow up
Type
Comment
Milestone Data
STARTED
FG00075 subjectsEligible participants who withdrew from treatment could enter the follow-up phase. 1 participant with withdrawal reason as Death in treatment phase was also counted in follow-up as exact date of last dose was unknown.
FG00173 subjectsEligible participants who withdrew from treatment could enter the follow-up phase.
FG00272 subjectsEligible participants who withdrew from treatment could enter the follow-up phase.
FG00373 subjectsEligible participants who withdrew from treatment could enter the follow-up phase.
FG00472 subjectsEligible participants who withdrew from treatment could enter the follow-up phase.
FG00574 subjectsEligible participants who withdrew from treatment could enter the follow-up phase.
FG00673 subjectsEligible participants who withdrew from treatment could enter the follow-up phase.
FG00764 subjectsEligible participants who withdrew from treatment could enter the follow-up phase.
FG00866 subjectsEligible participants who withdrew from treatment could enter the follow-up phase.
FG00964 subjectsEligible participants who withdrew from treatment could enter the follow-up phase.
FG01065 subjectsEligible participants who withdrew from treatment could enter the follow-up phase.
FG01166 subjectsEligible participants who withdrew from treatment could enter the follow-up phase.
FG01264 subjectsEligible participants who withdrew from treatment could enter the follow-up phase.
COMPLETED
FG00072 subjects
FG00173 subjects
FG00272 subjects
FG00372 subjects
FG004
NOT COMPLETED
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG003
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo (T2DM)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
BG001
PF-07081532 20mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally.
BG002
PF-07081532 40mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally.
BG003
PF-07081532 80mg (T2DM)
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.
BG004
PF-07081532 160mg (T2DM)
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.
BG005
PF-07081532 260mg (T2DM)
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.
BG006
Rybelsus 14mg (T2DM)
Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.
BG007
Placebo (Obesity)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
BG008
PF-07081532 80mg (Obesity)
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.
BG009
PF-07081532 140mg (Obesity)
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.
BG010
PF-07081532 200mg (Obesity,5 Steps)
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.
BG011
PF-07081532 200mg (Obesity,4 Steps)
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.
BG012
PF-07081532 260mg (Obesity)
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.
BG013
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00075
BG00173
BG00272
BG00373
BG00472
BG00574
BG00673
BG00764
BG00866
BG00964
BG01065
BG01166
BG01264
BG013901
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Less than (<) 18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00042
BG00130
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00014
BG00113
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Placebo-adjusted, Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)
Data was not collected for this outcome measure as the study was terminated prior to any participant reaching Week 32.
Posted
Baseline (result closest prior to dosing on Day 1), Week 32
ID
Title
Description
OG000
Placebo (T2DM)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 20mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally.
OG002
PF-07081532 40mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally.
OG003
PF-07081532 80mg (T2DM)
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.
OG004
PF-07081532 160mg (T2DM)
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.
OG005
PF-07081532 260mg (T2DM)
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.
OG006
Rybelsus 14mg (T2DM)
Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Primary
Placebo-adjusted, Percent Change From Baseline in Body Weight at Week 32: Cohort 2 (Obesity)
Body weight was measured using a calibrated weighing scale.
Data was not collected for this outcome measure as the study was terminated prior to any participant reaching Week 32.
Posted
Baseline (result closest prior to dosing on Day 1), week 32
ID
Title
Description
OG000
Placebo (Obesity)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 80mg (Obesity)
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.
OG002
PF-07081532 140mg (Obesity)
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.
OG003
PF-07081532 200mg (Obesity,5 Steps)
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.
Secondary
Percentage of Participants Who Achieved HbA1C <7% at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)
Data was not collected for this outcome measure as the study was terminated prior to any participant reaching Week 32.
Posted
Baseline (result closest prior to dosing on Day 1), Week 32
ID
Title
Description
OG000
Placebo (T2DM)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 20mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally.
OG002
PF-07081532 40mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally.
OG003
PF-07081532 80mg (T2DM)
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.
OG004
PF-07081532 160mg (T2DM)
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)
Data was not collected for this outcome measure as the study was terminated prior to any participant reaching Week 32.
Posted
Baseline (result closest prior to dosing on Day 1), Week 32
ID
Title
Description
OG000
Placebo (T2DM)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 20mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally.
OG002
PF-07081532 40mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally.
OG003
PF-07081532 80mg (T2DM)
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.
OG004
PF-07081532 160mg (T2DM)
Secondary
Percent Change From Baseline in Body Weight at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)
Body weight was measured using a calibrated weighing scale.
Data was not collected for this outcome measure as the study was terminated prior to any participant reaching Week 32.
Posted
Baseline (result closest prior to dosing on Day 1), Week 32
ID
Title
Description
OG000
Placebo (T2DM)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 20mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally.
OG002
PF-07081532 40mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally.
OG003
PF-07081532 80mg (T2DM)
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.
Secondary
Placebo-adjusted, Change From Baseline in HbA1C in the Rybelsus Arm at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)
This outcome measure was planned to be analyzed only for rybelsus arm and placebo arm as pre-specified in the protocol.
Data was not collected for this outcome measure as the study was terminated prior to any participant reaching Week 32.
Posted
Baseline (result closest prior to dosing on Day 1), Week 32
ID
Title
Description
OG000
Placebo (T2DM)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
Rybelsus 14mg (T2DM)
Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants Achieving >=5%, >=10%, and >=15% Body Weight Loss at Week 32 Relative to Baseline: Cohort 2 (Obesity)
Data was not collected for this outcome measure as the study was terminated prior to any participant reaching Week 32.
Posted
Baseline (result closest prior to dosing on Day 1), Week 32
ID
Title
Description
OG000
Placebo (Obesity)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 80mg (Obesity)
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.
OG002
PF-07081532 140mg (Obesity)
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.
OG003
PF-07081532 200mg (Obesity,5 Steps)
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.
Secondary
Absolute Change From Baseline in Waist Circumference at Week 32: Cohort 2 (Obesity)
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).
Data was not collected for this outcome measure as the study was terminated prior to any participant reaching Week 32.
Posted
Baseline (result closest prior to dosing on Day 1), Week 32
ID
Title
Description
OG000
Placebo (Obesity)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 80mg (Obesity)
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.
OG002
PF-07081532 140mg (Obesity)
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.
OG003
PF-07081532 200mg (Obesity,5 Steps)
Secondary
Absolute Change From Baseline in Waist-to-hip Ratio at Week 32: Cohort 2 (Obesity)
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).
Data was not collected for this outcome measure as the study was terminated prior to any participant reaching Week 32.
Posted
Baseline (result closest prior to dosing on Day 1), Week 32
ID
Title
Description
OG000
Placebo (Obesity)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 80mg (Obesity)
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.
OG002
PF-07081532 140mg (Obesity)
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.
Secondary
Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 32: Cohort 2 (Obesity)
HOMA-IR was calculated as: fasting plasma insulin ([FPI]*(FPG)/405 and measured in terms of mg/dL* (milliunits per liter).
Data was not collected for this outcome measure as the study was terminated prior to any participant reaching Week 32.
Posted
Baseline (result closest prior to dosing on Day 1), Week 32
ID
Title
Description
OG000
Placebo (Obesity)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 80mg (Obesity)
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.
OG002
PF-07081532 140mg (Obesity)
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.
OG003
PF-07081532 200mg (Obesity,5 Steps)
Secondary
Change From Baseline in Homeostatic Model Assessment for Insulin Sensitivity (HOMA-S) at Week 32: Cohort 2 (Obesity)
HOMA-S was calculated as (22.5/[FPI] * FPG) *100 and measured in terms of percentage sensitivity.
Data was not collected for this outcome measure as the study was terminated prior to any participant reaching Week 32.
Posted
Baseline (result closest prior to dosing on Day 1), Week 32
ID
Title
Description
OG000
Placebo (Obesity)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 80mg (Obesity)
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.
OG002
PF-07081532 140mg (Obesity)
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.
OG003
PF-07081532 200mg (Obesity,5 Steps)
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs): Cohort 1 (Type 2 Diabetes Mellitus)
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.
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.
Posted
Count of Participants
Participants
From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
ID
Title
Description
OG000
Placebo (T2DM)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 20mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally.
OG002
PF-07081532 40mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally.
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs): Cohort 2 (Obesity)
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.
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.
Posted
Count of Participants
Participants
From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
ID
Title
Description
OG000
Placebo (Obesity)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 80mg (Obesity)
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.
OG002
PF-07081532 140mg (Obesity)
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.
Secondary
Number of Participants With Serious Adverse Events (SAEs): Cohort 1 (Type 2 Diabetes Mellitus)
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.
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.
Posted
Count of Participants
Participants
From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
ID
Title
Description
OG000
Placebo (T2DM)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 20mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally.
OG002
PF-07081532 40mg (T2DM)
Secondary
Number of Participants With Serious Adverse Events (SAEs): Cohort 2 (Obesity)
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.
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.
Posted
Count of Participants
Participants
From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
ID
Title
Description
OG000
Placebo (Obesity)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 80mg (Obesity)
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.
OG002
Secondary
Number of Participants Reporting Adverse Events Leading to Permanent Discontinuation From Study Treatment and Study: Cohort 1 (Type 2 Diabetes Mellitus)
\ 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.
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.
Posted
Count of Participants
Participants
From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
ID
Title
Description
OG000
Placebo (T2DM)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 20mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally.
Secondary
Number of Participants Reporting Adverse Events Leading to Permanent Discontinuation From Study Treatment and Study: Cohort 2 (Obesity)
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.
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.
Posted
Count of Participants
Participants
From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
ID
Title
Description
OG000
Placebo (Obesity)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 80mg (Obesity)
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.
Secondary
Number of Participants With Hypoglycemic Adverse Events (HAE) According to Titration Dose: Cohort 1 (Type 2 Diabetes Mellitus)
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.
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.
Posted
Count of Participants
Participants
Up to week 28
ID
Title
Description
OG000
Placebo (T2DM
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
Secondary
Number of Participants With Hypoglycemic Adverse Events According to Titration Dose: Cohort 2 (Obesity)
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.
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.
Posted
Count of Participants
Participants
Up to week 28
ID
Title
Description
OG000
Placebo (Obesity)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
Secondary
Number of Participants With Vital Sign Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)
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.
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.
Posted
Count of Participants
Participants
Up to week 28
ID
Title
Description
OG000
Placebo (T2DM)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 20mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally.
OG002
PF-07081532 40mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally.
Secondary
Number of Participants With Vital Sign Abnormalities: Cohort 2 (Obesity)
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.
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.
Posted
Count of Participants
Participants
Up to week 28
ID
Title
Description
OG000
Placebo (Obesity)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 80mg (Obesity)
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.
OG002
PF-07081532 140mg (Obesity)
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.
Secondary
Number of Participants With Clinical Laboratory Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)
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.
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.
Posted
Count of Participants
Participants
Up to week 28
ID
Title
Description
OG000
Placebo (T2DM)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 20mg (T2DM)
Secondary
Number of Participants With Clinical Laboratory Abnormalities: Cohort 2 (Obesity)
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.
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.
Posted
Count of Participants
Participants
Up to week 28
ID
Title
Description
OG000
Placebo (Obesity)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 80mg (Obesity)
Secondary
Number of Participants With ECG Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)
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.
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.
Posted
Count of Participants
Participants
Up to week 28
ID
Title
Description
OG000
Placebo (T2DM)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 20mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally.
OG002
PF-07081532 40mg (T2DM)
Secondary
Number of Participants With ECG Abnormalities: Cohort 2 (Obesity)
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.
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.
Posted
Count of Participants
Participants
Up to week 28
ID
Title
Description
OG000
Placebo (Obesity)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 80mg (Obesity)
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.
OG002
PF-07081532 140mg (Obesity)
Secondary
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS) Category: Cohort 2 (Obesity) Only
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
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.
Posted
Count of Participants
Participants
Baseline (result closest prior to dosing on Day 1), anytime post-baseline (Up to Week 28)
ID
Title
Description
OG000
Placebo (Obesity)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
Other Pre-specified
Placebo-adjusted, Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)
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.
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.
Posted
Least Squares Mean
Standard Error
Percentage of HbA1c
Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16
ID
Title
Description
OG000
Placebo (T2DM)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 20mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally.
OG002
PF-07081532 40mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally.
Other Pre-specified
Placebo-adjusted, Percent Change From Baseline in Body Weight at Week 20: Cohort 2 (Obesity)
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.
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.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 20
ID
Title
Description
OG000
Placebo (Obesity)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 80mg (Obesity)
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.
OG002
PF-07081532 140mg (Obesity)
Other Pre-specified
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)
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.
Posted
Mean
Standard Deviation
Milligrams per deciliter
Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16
ID
Title
Description
OG000
Placebo (T2DM)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 20mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally.
OG002
PF-07081532 40mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally.
OG003
PF-07081532 80mg (T2DM)
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.
Other Pre-specified
Percent Change From Baseline in Body Weight at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)
Body weight was measured using a calibrated weighing scale.
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.
Posted
Mean
Standard Deviation
Percent change
Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16
ID
Title
Description
OG000
Placebo (T2DM)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 20mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally.
OG002
PF-07081532 40mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally.
OG003
PF-07081532 80mg (T2DM)
Other Pre-specified
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)
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.
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.
Posted
Least Squares Mean
Standard Error
Percentage of HbA1C
Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16
ID
Title
Description
OG000
Rybelsus 14mg (T2DM)
Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.
OG001
Placebo (T2DM)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
Units
Counts
Other Pre-specified
Absolute Change From Baseline in Waist Circumference at Week 12 and 24: Cohort 2 (Obesity)
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).
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.
Posted
Mean
Standard Deviation
Centimeter
Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], Week 12, 24
ID
Title
Description
OG000
Placebo (Obesity)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 80mg (Obesity)
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.
OG002
PF-07081532 140mg (Obesity)
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.
Other Pre-specified
Absolute Change From Baseline in Waist-to-hip Ratio at Week 12 and Week 24: Cohort 2 (Obesity)
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).
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.
Posted
Mean
Standard Deviation
Ratio
Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], week 12, 24
ID
Title
Description
OG000
Placebo (Obesity)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 80mg (Obesity)
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.
OG002
PF-07081532 140mg (Obesity)
Other Pre-specified
Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 16: Cohort 2 (Obesity)
HOMA-IR was calculated as: ([FPI]*(FPG)/405 in terms of Mg/dL* (milliunits per liter).
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.
Posted
Mean
Standard Deviation
Milliunits per liter
Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16
ID
Title
Description
OG000
Placebo (Obesity)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 80mg (Obesity)
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.
OG002
PF-07081532 140mg (Obesity)
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.
Other Pre-specified
Change From Baseline in Homeostatic Model Assessment for Insulin Sensitivity (HOMA-S) at Week 16: Cohort 2 (Obesity)
HOMA-S was calculated as (22.5/[FPI]*FPG)) *100 and measured in terms of. percentage sensitivity.
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.
Posted
Mean
Standard Deviation
Percentage sensitivity
Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16
ID
Title
Description
OG000
Placebo (Obesity)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
OG001
PF-07081532 80mg (Obesity)
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.
OG002
PF-07081532 140mg (Obesity)
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.
Time Frame
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.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo (T2DM)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
1
75
1
75
23
75
EG001
PF-07081532 20mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally.
0
73
0
73
31
73
EG002
PF-07081532 40mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally.
0
72
3
72
46
72
EG003
PF-07081532 80mg (T2DM)
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.
0
73
3
73
37
73
EG004
PF-07081532 160mg (T2DM)
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.
0
72
1
72
41
72
EG005
PF-07081532 260mg (T2DM)
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.
0
74
2
74
51
74
EG006
Rybelsus 14mg (T2DM)
Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.
0
73
1
73
32
73
EG007
Placebo (Obesity)
Participants randomized to receive a single dose of PF-07081532-matching placebo QD orally.
0
64
1
64
42
64
EG008
PF-07081532 80mg (Obesity)
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.
0
66
2
66
50
66
EG009
PF-07081532 140mg (Obesity)
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.
0
64
2
64
48
64
EG010
PF-07081532 200mg (Obesity,5 Steps)
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.
0
65
1
65
55
65
EG011
PF-07081532 200mg (Obesity,4 Steps)
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.
0
66
2
66
59
66
EG012
PF-07081532 260mg (Obesity)
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.
0
64
2
64
53
64
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG0030 affected73 at risk
EG0040 affected72 at risk
EG0050 affected74 at risk
EG0060 affected73 at risk
EG0070 affected64 at risk
EG0080 affected66 at risk
EG0091 affected64 at risk
EG0100 affected65 at risk
EG0110 affected66 at risk
EG0120 affected64 at risk
Atrial fibrillation
Cardiac disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Sepsis
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0021 affected72 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0021 affected72 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0021 affected72 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Liver function test abnormal
Investigations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Carcinoid tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Syncope
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Allergic respiratory symptom
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Liver function test increased
Investigations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal distension
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0011 affected73 at risk
EG0025 affected72 at risk
EG0032 affected73 at risk
EG0042 affected72 at risk
EG0051 affected74 at risk
EG0061 affected73 at risk
EG0074 affected64 at risk
EG0082 affected66 at risk
EG0093 affected64 at risk
EG0101 affected65 at risk
EG0113 affected66 at risk
EG0124 affected64 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0025 affected72 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0013 affected73 at risk
EG0025 affected72 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected75 at risk
EG0012 affected73 at risk
EG0027 affected72 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected75 at risk
EG0018 affected73 at risk
EG0029 affected72 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected75 at risk
EG0013 affected73 at risk
EG0022 affected72 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0022 affected72 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0003 affected75 at risk
EG00111 affected73 at risk
EG00217 affected72 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected75 at risk
EG0011 affected73 at risk
EG0026 affected72 at risk
EG003
Fatigue
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0024 affected72 at risk
EG003
COVID-19
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0012 affected73 at risk
EG0020 affected72 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0001 affected75 at risk
EG0010 affected73 at risk
EG0023 affected72 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0001 affected75 at risk
EG0011 affected73 at risk
EG0024 affected72 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected75 at risk
EG0011 affected73 at risk
EG0025 affected72 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected75 at risk
EG0012 affected73 at risk
EG0021 affected72 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0002 affected75 at risk
EG0010 affected73 at risk
EG0021 affected72 at risk
EG003
Headache
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0012 affected73 at risk
EG0025 affected72 at risk
EG003
Hypertension
Vascular disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0021 affected72 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected75 at risk
EG0010 affected73 at risk
EG0021 affected72 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0023 affected72 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0001 affected75 at risk
EG0011 affected73 at risk
EG0020 affected72 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0002 affected75 at risk
EG0011 affected73 at risk
EG0021 affected72 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0021 affected72 at risk
EG003
Lipase increased
Investigations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0013 affected73 at risk
EG0024 affected72 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v26.0
Non-systematic Assessment
EG0006 affected75 at risk
EG0011 affected73 at risk
EG0021 affected72 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Gastrititis
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0021 affected72 at risk
EG003
Asthenia
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Chest discomfort
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Early satiety
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Pain
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Cystitis
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Ear infection
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0002 affected75 at risk
EG0011 affected73 at risk
EG0020 affected72 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Palpitations
Cardiac disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Viral infection
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Amylase increased
Investigations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0022 affected72 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0021 affected72 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Liver function test increased
Investigations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0021 affected72 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0012 affected73 at risk
EG0020 affected72 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0012 affected73 at risk
EG0020 affected72 at risk
EG003
Head discomfort
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0022 affected72 at risk
EG003
Migraine
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0023 affected72 at risk
EG003
Microalbuminuria
Renal and urinary disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0012 affected73 at risk
EG0020 affected72 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0012 affected73 at risk
EG0020 affected72 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0021 affected72 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0002 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Flushing
Vascular disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Hypotension
Vascular disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0021 affected72 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0012 affected73 at risk
EG0020 affected72 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA v26.0
Non-systematic Assessment
EG0000 affected75 at risk
EG0010 affected73 at risk
EG0020 affected72 at risk
EG003
1 participant in placebo (T2DM) arm with withdrawal reason as Death in treatment phase was also counted in follow-up with the reason for discontinuation as death since exact date of last dose was unknown.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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.
OG005
PF-07081532 260mg (Obesity)
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.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
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.
OG005
PF-07081532 260mg (T2DM)
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.
OG006
Rybelsus 14mg (T2DM)
Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
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.
OG005
PF-07081532 260mg (T2DM)
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.
OG006
Rybelsus 14mg (T2DM)
Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG004
PF-07081532 160mg (T2DM)
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.
OG005
PF-07081532 260mg (T2DM)
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.
OG006
Rybelsus 14mg (T2DM)
Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
0
OG0010
OG004
PF-07081532 200mg (Obesity,4 Steps)
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.
OG005
PF-07081532 260mg (Obesity)
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.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
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.
OG004
PF-07081532 200mg (Obesity,4 Steps)
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.
OG005
PF-07081532 260mg (Obesity)
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.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG003
PF-07081532 200mg (Obesity,5 Steps)
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.
OG004
PF-07081532 200mg (Obesity,4 Steps)
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.
OG005
PF-07081532 260mg (Obesity)
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.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
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.
OG004
PF-07081532 200mg (Obesity,4 Steps)
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.
OG005
PF-07081532 260mg (Obesity)
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.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
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.
OG004
PF-07081532 200mg (Obesity,4 Steps)
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.
OG005
PF-07081532 260mg (Obesity)
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.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG003
PF-07081532 80mg (T2DM)
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.
OG004
PF-07081532 160mg (T2DM)
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.
OG005
PF-07081532 260mg (T2DM)
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.
OG006
Rybelsus 14mg (T2DM)
Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.
Units
Counts
Participants
OG00075
OG00173
OG00272
OG00373
OG00472
OG00574
OG00673
Title
Denominators
Categories
Title
Measurements
OG00035
OG00137
OG00250
OG00344
OG00445
OG00556
OG00636
OG003
PF-07081532 200mg (Obesity,5 Steps)
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.
OG004
PF-07081532 200mg (Obesity,4 Steps)
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.
OG005
PF-07081532 260mg (Obesity)
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.
Units
Counts
Participants
OG00064
OG00166
OG00264
OG00365
OG00466
OG00564
Title
Denominators
Categories
Title
Measurements
OG00044
OG00154
OG00250
OG00356
OG00460
OG00553
Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally.
OG003
PF-07081532 80mg (T2DM)
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.
OG004
PF-07081532 160mg (T2DM)
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.
OG005
PF-07081532 260mg (T2DM)
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.
OG006
Rybelsus 14mg (T2DM)
Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.
Units
Counts
Participants
OG00075
OG00173
OG00272
OG00373
OG00472
OG00574
OG00673
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0023
OG0033
OG0041
OG0052
OG0061
PF-07081532 140mg (Obesity)
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.
OG003
PF-07081532 200mg (Obesity,5 Steps)
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.
OG004
PF-07081532 200mg (Obesity,4 Steps)
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.
OG005
PF-07081532 260mg (Obesity)
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.
Units
Counts
Participants
OG00064
OG00166
OG00264
OG00365
OG00466
OG00564
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
OG0022
OG0031
OG0042
OG0052
OG002
PF-07081532 40mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally.
OG003
PF-07081532 80mg (T2DM)
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.
OG004
PF-07081532 160mg (T2DM)
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.
OG005
PF-07081532 260mg (T2DM)
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.
OG006
Rybelsus 14mg (T2DM)
Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.
Units
Counts
Participants
OG00075
OG00173
OG00272
OG00373
OG00472
OG00574
OG00673
Title
Denominators
Categories
Discontinuations from study due to TEAEs
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Permanent discontinuations from any study intervention due to TEAEs
Title
Measurements
OG0000
OG0013
OG00211
OG003
OG002
PF-07081532 140mg (Obesity)
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.
OG003
PF-07081532 200mg (Obesity,5 Steps)
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.
OG004
PF-07081532 200mg (Obesity,4 Steps)
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.
OG005
PF-07081532 260mg (Obesity)
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.
Units
Counts
Participants
OG00064
OG00166
OG00264
OG00365
OG00466
OG00564
Title
Denominators
Categories
Discontinuations from study due to TEAEs
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0051
Permanent discontinuations from any study intervention due to TEAEs
Title
Measurements
OG0005
OG00112
OG00219
OG003
OG001
PF-07081532 20mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally.
OG002
PF-07081532 40 mg (T2DM)
Participants with T2DM inadequately controlled with metformin who received PF-07081532 40 mg QD orally were included.
OG003
PF-07081532 60mg (T2DM)
Participants with T2DM inadequately controlled with metformin who received PF-07081532 60 mg QD orally were included.
OG004
PF-07081532 80 mg (T2DM)
Participants with T2DM inadequately controlled with metformin who received PF-07081532 80 mg QD orally were included.
OG005
PF-07081532 120 mg (T2DM)
Participants with T2DM inadequately controlled with metformin who received PF-07081532 120 mg QD orally were included.
OG006
PF-07081532 140mg (T2DM)
Participants with T2DM inadequately controlled with metformin who received PF-07081532 140 mg QD orally were included.
OG007
PF-07081532 160mg (T2DM)
Participants with T2DM inadequately controlled with metformin who received PF-07081532 160 mg QD orally were included.
OG008
PF-07081532 200mg (T2DM)
Participants with T2DM inadequately controlled with metformin who received PF-07081532 200 mg QD orally were included.
OG009
PF-07081532 260 mg (T2DM)
Participants with T2DM inadequately controlled with metformin who received PF-07081532 260 mg QD orally were included.
OG010
Rybelsus 3mg (T2DM)
Participants with T2DM inadequately controlled with metformin who received Rybelsus 3 mg QD orally were included.
OG011
Rybelsus 7mg (T2DM)
Participants with T2DM inadequately controlled with metformin who received Rybelsus 7 mg QD orally were included.
OG012
Rybelsus 14mg (T2DM)
Participants with T2DM inadequately controlled with metformin who received Rybelsus 14 mg QD orally were included.
Units
Counts
Participants
OG00075
OG001364
OG002281
OG003136
OG004193
OG00525
OG00658
OG0077
OG00820
OG0096
OG01073
OG01172
OG01270
Title
Denominators
Categories
Severe Hypoglycemia
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
Documented Symptomatic Hypoglycemia
Title
Measurements
OG0000
OG0010
OG0022
OG003
Asymptomatic Hypoglycemia
Title
Measurements
OG0001
OG0010
OG0021
OG003
Probable Symptomatic Hypoglycemia
Title
Measurements
OG0000
OG0011
OG0020
OG003
OG001
PF-07081532 20mg (Obesity)
Participants with obesity who received PF-07081532 20 mg QD orally were included.
OG002
PF-07081532 40 mg (Obesity)
Participants with obesity who received PF-07081532 40 mg QD orally were included.
OG003
PF-07081532 60 mg (Obesity)
Participants with obesity who received PF-07081532 60 mg QD orally were included.
OG004
PF-07081532 80mg (Obesity)
Participants with obesity who received PF-07081532 80 mg QD orally were included.
OG005
PF-07081532 100 mg (Obesity)
Participants with obesity who received PF-07081532 100 mg QD orally were included.
OG006
PF-07081532 120 mg (Obesity)
Participants with obesity who received PF-07081532 120 mg QD orally were included.
OG007
PF-07081532 140mg (Obesity)
Participants with obesity who received PF-07081532 140 mg QD orally were included.
OG008
PF-07081532 160 mg (Obesity)
Participants with obesity who received PF-07081532 160 mg QD orally were included.
OG009
PF-07081532 200 mg (Obesity)
Participants with obesity who received PF-07081532 200 mg QD orally were included.
OG010
PF-07081532 260 mg (Obesity)
Participants with obesity who received PF-07081532 260 mg QD orally were included.
Units
Counts
Participants
OG00064
OG001325
OG002310
OG003170
OG004220
OG00556
OG00643
OG007140
OG00847
OG009121
OG01028
Title
Denominators
Categories
Severe Hypoglycemia
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
Documented Symptomatic Hypoglycemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Asymptomatic Hypoglycemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Probable Symptomatic Hypoglycemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
PF-07081532 80mg (T2DM)
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.
OG004
PF-07081532 160mg (T2DM)
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.
OG005
PF-07081532 260mg (T2DM)
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.
OG006
Rybelsus 14 mg (T2DM)
Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.
Units
Counts
Participants
OG00075
OG00173
OG00272
OG00373
OG00472
OG00574
OG00673
Title
Denominators
Categories
Systolic Blood Pressure (mmHg) Value <90 mmHg
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0041
OG0050
OG0060
Systolic Blood Pressure (mmHg) Value >200 mmHg
Title
Measurements
OG0000
OG0010
OG0020
OG003
Diastolic Blood Pressure (mmHg) Value <40 mmHg
Title
Measurements
OG0000
OG0010
OG0020
OG003
Diastolic Blood Pressure (mmHg) Value >100 mmHg
Title
Measurements
OG0000
OG0014
OG0022
OG003
Pulse Rate (bpm) Value <40 bpm
Title
Measurements
OG0000
OG0010
OG0020
OG003
Pulse Rate (bpm) Value >110 bpm
Title
Measurements
OG0000
OG0011
OG0021
OG003
OG003
PF-07081532 200mg (Obesity,5 Steps)
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.
OG004
PF-07081532 200mg (Obesity,4 Steps)
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.
OG005
PF-07081532 260mg (Obesity)
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.
Units
Counts
Participants
OG00064
OG00166
OG00264
OG00365
OG00466
OG00564
Title
Denominators
Categories
Systolic Blood Pressure (mmHg) Value <90 mmHg
Title
Measurements
OG0000
OG0013
OG0020
OG0032
OG0040
OG0051
Systolic Blood Pressure (mmHg) Value >200 mmHg
Title
Measurements
OG0000
OG0010
OG0020
OG003
Diastolic Blood Pressure (mmHg) Value <40 mmHg
Title
Measurements
OG0000
OG0010
OG0020
OG003
Diastolic Blood Pressure (mmHg) Value >100 mmHg
Title
Measurements
OG0004
OG0014
OG0024
OG003
Pulse Rate (bpm) Value <40 bpm
Title
Measurements
OG0000
OG0010
OG0020
OG003
Pulse Rate (bpm) Value >110 bpm
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants randomized to receive PF-07081532 20 mg QD orally.
OG002
PF-07081532 40mg (T2DM)
Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally.
OG003
PF-07081532 80mg (T2DM)
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.
OG004
PF-07081532 160mg (T2DM)
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.
OG005
PF-07081532 260mg (T2DM)
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.
OG006
Rybelsus 14mg (T2DM)
Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.
Units
Counts
Participants
OG00075
OG00173
OG00272
OG00372
OG00471
OG00573
OG00673
Title
Denominators
Categories
Title
Measurements
OG00067
OG00164
OG00257
OG00357
OG00461
OG00559
OG00664
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.
OG002
PF-07081532 140mg (Obesity)
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.
OG003
PF-07081532 200mg (Obesity,5 Steps)
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.
OG004
PF-07081532 200mg (Obesity,4 Steps)
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.
OG005
PF-07081532 260mg (Obesity)
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.
Units
Counts
Participants
OG00064
OG00163
OG00263
OG00363
OG00466
OG00564
Title
Denominators
Categories
Title
Measurements
OG00036
OG00131
OG00240
OG00340
OG00448
OG00536
Participants randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally.
OG003
PF-07081532 80mg (T2DM)
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.
OG004
PF-07081532 160mg (T2DM)
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.
OG005
PF-07081532 260mg (T2DM)
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.
OG006
Rybelsus 14mg (T2DM)
Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.
Units
Counts
Participants
OG00075
OG00173
OG00272
OG00373
OG00472
OG00574
OG00673
Title
Denominators
Categories
PR Interval, (MSEC) value >=300
Title
Measurements
OG0001
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
PR Interval, (MSEC) %Chg >= 25/50%
Title
Measurements
OG0000
OG0010
OG0020
OG003
QRS duration, (MSEC) value >=140
Title
Measurements
OG0001
OG0010
OG0020
OG003
QRS duration, (MSEC) %Chg >=50%
Title
Measurements
OG0000
OG0010
OG0020
OG003
QT interval, single beat (MSEC) value > 500
Title
Measurements
OG0000
OG0010
OG0020
OG003
QTCF interval, single beat (MSEC) 450 < Value <=480
Title
Measurements
OG0005
OG0017
OG0023
OG003
QTCF interval, single beat (MSEC) 480 < Value <=500
Title
Measurements
OG0000
OG0010
OG0020
OG003
QTCF interval, single beat (MSEC) Value > 500
Title
Measurements
OG0000
OG0010
OG0020
OG003
QTCF interval, single beat (MSEC) 30 <= Chg <= 60
Title
Measurements
OG0003
OG0017
OG0025
OG003
QTCF interval, single beat (MSEC) Chg > 60
Title
Measurements
OG0000
OG0010
OG0020
OG003
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.
OG003
PF-07081532 200mg (Obesity,5 Steps)
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.
OG004
PF-07081532 200mg (Obesity,4 Steps)
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.
OG005
PF-07081532 260mg (Obesity)
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.
Units
Counts
Participants
OG00064
OG00166
OG00264
OG00365
OG00466
OG00564
Title
Denominators
Categories
PR Interval, (MSEC) value >=300
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
PR Interval, (MSEC) %Chg >= 25/50%
Title
Measurements
OG0000
OG0010
OG0020
OG003
QRS duration, (MSEC) value >=140
Title
Measurements
OG0001
OG0010
OG0020
OG003
QRS duration, (MSEC) %Chg >=50%
Title
Measurements
OG0000
OG0010
OG0020
OG003
QT interval, single beat (MSEC) value > 500
Title
Measurements
OG0000
OG0010
OG0020
OG003
QTCF interval, single beat (MSEC) 450 < Value <=480
Title
Measurements
OG0009
OG0013
OG0024
OG003
QTCF interval, single beat (MSEC) 480 < Value <=500
Title
Measurements
OG0000
OG0010
OG0020
OG003
QTCF interval, single beat (MSEC) Value > 500
Title
Measurements
OG0000
OG0010
OG0020
OG003
QTCF interval, single beat (MSEC) 30 <= Chg <= 60
Title
Measurements
OG0003
OG0018
OG0024
OG003
QTCF interval, single beat (MSEC) Chg > 60
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG001
PF-07081532 80mg (Obesity)
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.
OG002
PF-07081532 140mg (Obesity)
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.
OG003
PF-07081532 200mg (Obesity,5 Steps)
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.
OG004
PF-07081532 200mg (Obesity,4 Steps)
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.
OG005
PF-07081532 260mg (Obesity)
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.
Units
Counts
Participants
OG00064
OG00166
OG00264
OG00365
OG00466
OG00564
Title
Denominators
Categories
Baseline: <1> Completed suicide
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Baseline: <2> Suicide attempt
Title
Measurements
OG0000
OG0010
OG0020
OG003
Baseline: <3> Preparatory acts towards imminent suicidal behavior
Title
Measurements
OG0000
OG0010
OG0020
OG003
Baseline: <4> Suicidal ideation
Title
Measurements
OG0000
OG0010
OG0020
OG003
Baseline: <7> Self-injurious behavior, no suicidal intent
Title
Measurements
OG0000
OG0010
OG0020
OG003
Post-Baseline: <1> Completed suicide
Title
Measurements
OG0000
OG0010
OG0020
OG003
Post-Baseline: <2> Suicide attempt
Title
Measurements
OG0000
OG0010
OG0020
OG003
Post-Baseline: <3> Preparatory acts towards imminent suicidal behavior
Title
Measurements
OG0001
OG0010
OG0020
OG003
Post-Baseline: <4> Suicidal ideation
Title
Measurements
OG0000
OG0010
OG0020
OG003
Post-Baseline: <7> Self-injurious behavior, no suicidal intent
Title
Measurements
OG0001
OG0010
OG0020
OG003
OG003
PF-07081532 80mg (T2DM)
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.
OG004
PF-07081532 160mg (T2DM)
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.
OG005
PF-07081532 260mg (T2DM)
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.
OG006
Rybelsus 14mg (T2DM)
Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.
Units
Counts
Participants
OG00024
OG00130
OG00221
OG00322
OG00425
OG00521
OG00624
Title
Denominators
Categories
Title
Measurements
OG000-0.07± 0.109
OG001-1.03± 0.106
OG002-1.37± 0.112
OG003-1.44± 0.111
OG004-1.34± 0.110
OG005-1.36± 0.114
OG006-0.94± 0.109
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
<.0001
LS Mean Difference
-0.95
2-Sided
90
-1.20
-0.70
Other
OG000
OG002
Mixed Models Analysis
<.0001
LS Mean Difference
-1.30
2-Sided
90
-1.55
-1.04
Other
OG000
OG003
Mixed Models Analysis
<.0001
LS Mean Difference
-1.37
90
-1.62
-1.11
Other
OG000
OG004
Mixed Models Analysis
<.0001
LS Mean Difference
-1.26
2-Sided
90
-1.52
-1.01
Other
OG000
OG005
Mixed Models Analysis
<.0001
LS Mean Difference
-1.29
90
-1.55
-1.03
Other
OG000
OG006
Mixed Models Analysis
<.0001
LS Mean Difference
-0.86
2-Sided
90
-1.12
-0.61
Other
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.
OG003
PF-07081532 200mg (Obesity,5 Steps)
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.
OG004
PF-07081532 200mg (Obesity,4 Steps)
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.
OG005
PF-07081532 260mg (Obesity)
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.
Units
Counts
Participants
OG00045
OG00144
OG00237
OG00338
OG00431
OG00528
Title
Denominators
Categories
Title
Measurements
OG000-1.84± 0.612
OG001-4.28± 0.623
OG002-6.21± 0.654
OG003-7.47± 0.628
OG004-6.88± 0.638
OG005-7.26± 0.664
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
0.0055
LS Mean Difference
-2.44
2-Sided
90
-3.88
-1.00
Other
OG000
OG002
Mixed Models Analysis
<.0001
LS Mean Difference
-4.37
2-Sided
90
-5.84
-2.89
Other
OG000
OG003
Mixed Models Analysis
<.0001
LS Mean Difference
-5.63
2-Sided
90
-7.07
-4.18
Other
OG000
OG004
Mixed Models Analysis
<.0001
LS Mean Difference
-5.04
2-Sided
90
-6.50
-3.58
Other
OG000
OG005
Mixed Models Analysis
<.0001
LS Mean Difference
-5.42
2-Sided
90
-6.91
-3.93
Other
OG004
PF-07081532 160mg (T2DM)
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.
OG005
PF-07081532 260mg (T2DM)
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.
OG006
Rybelsus 14mg (T2DM)
Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.
Units
Counts
Participants
OG00024
OG00130
OG00221
OG00322
OG00425
OG00521
OG00624
Title
Denominators
Categories
Title
Measurements
OG000160.70± 39.595
OG001135.59± 31.746
OG002127.00± 35.928
OG003132.19± 31.541
OG004127.65± 28.839
OG005125.07± 46.924
OG006130.06± 28.120
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.
OG004
PF-07081532 160mg (T2DM)
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.
OG005
PF-07081532 260mg (T2DM)
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.
OG006
Rybelsus 14mg (T2DM)
Participants randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.
Units
Counts
Participants
OG00029
OG00132
OG00230
OG00328
OG00428
OG00530
OG00627
Title
Denominators
Categories
Title
Measurements
OG00093.164± 22.0659
OG00186.251± 17.3464
OG00291.556± 23.4071
OG00392.979± 24.5045
OG00485.564± 17.9582
OG00587.658± 21.6950
OG00691.799± 20.4605
Participants
OG00024
OG00124
Title
Denominators
Categories
Title
Measurements
OG000-0.94± 0.109
OG001-0.07± 0.109
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
<.0001
LS Mean Difference
-0.86
2-Sided
90
-1.12
-0.61
Other
OG003
PF-07081532 200mg (Obesity,5 Steps)
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.
OG004
PF-07081532 200mg (Obesity,4 Steps)
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.
OG005
PF-07081532 260mg (Obesity)
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.
Units
Counts
Participants
OG00057
OG00153
OG00249
OG00356
OG00453
OG00550
Title
Denominators
Categories
Week 12
ParticipantsOG00057
ParticipantsOG00153
ParticipantsOG00249
ParticipantsOG00356
ParticipantsOG00453
ParticipantsOG00550
Title
Measurements
OG000-2.702± 4.1726
OG001-2.574± 5.0872
OG002-3.017± 5.9117
OG003
Week 24
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG0039
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.
OG003
PF-07081532 200mg (Obesity,5 Steps)
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.
OG004
PF-07081532 200mg (Obesity,4 Steps)
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.
OG005
PF-07081532 260mg (Obesity)
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.
Units
Counts
Participants
OG00057
OG00153
OG00249
OG00356
OG00453
OG00550
Title
Denominators
Categories
Week 12
ParticipantsOG00057
ParticipantsOG00153
ParticipantsOG00249
ParticipantsOG00356
ParticipantsOG00453
ParticipantsOG00550
Title
Measurements
OG000-0.013± 0.0374
OG001-0.002± 0.0459
OG002-0.006± 0.0578
OG003
Week 24
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG0039
OG003
PF-07081532 200mg (Obesity,5 Steps)
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.
OG004
PF-07081532 200mg (Obesity,4 Steps)
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.
OG005
PF-07081532 260mg (Obesity)
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.
Units
Counts
Participants
OG00053
OG00148
OG00242
OG00346
OG00442
OG00539
Title
Denominators
Categories
Title
Measurements
OG0000.630± 2.1753
OG0010.185± 2.0579
OG002-0.121± 4.7540
OG0030.984± 3.9090
OG004-1.172± 2.7360
OG005-0.210± 1.1373
OG003
PF-07081532 200mg (Obesity,5 Steps)
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.
OG004
PF-07081532 200mg (Obesity,4 Steps)
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.
OG005
PF-07081532 260mg (Obesity)
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.