A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-GROUP STUDY TO EVALUATE THE PHARMACOKINETICS OF PF-07081532 IN ADULT PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING DEGREES OF RENAL IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT RENAL IMPAIRMENT
Phase: PHASE1
Conditions: Type 2 Diabetes, Renal Impairment
Sponsor: Pfizer

PF-07081532
Protocol C3991007
Final Protocol, 03 June 2022
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Pharmacology Protocol Template (01 April 2022)
TMF Doc ID: 164.01
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A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-GROUP STUDY TO 
EVALUATE THE PHARMACOKINETICS OF PF-07081532 IN ADULT 
PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING 
DEGREES OF RENAL IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT 
RENAL IMPAIRMENT
Study Intervention Number:
PF-07081532
Study Intervention Name:
Not Applicable (N/A)
US IND Number:
147045
EudraCT/CTIS Number:
N/A
ClinicalTrials.gov ID:  
Not Available
Pediatric Investigational Plan Number:
N/A
Protocol Number:
C3991007
Phase:
1
Brief Title: A Study to Investigate the Effects of Renal Impairment on the 
Pharmacokinetics of PF-07081532
This document and accompanying materials contain confidential information belonging to Pfizer. Except as 
otherwise agreed to in writing, by accepting or reviewing these documents, you agree to hold this 
information in confidence and not copy or disclose it to others (except where required by applicable law) or 
use it for unauthorized purposes. In the event of any actual or suspected breach of this obligation, Pfizer 
must be promptly notified.
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Document History
Document
Version Date
Original protocol
03 June 2022
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TABLE OF CONTENTS
LIST OF TABLES.....................................................................................................................8
1. PROTOCOL SUMMARY.....................................................................................................9
1.1. Synopsis ....................................................................................................................9
1.2. Schema ....................................................................................................................15
1.3. Schedule of Activities .............................................................................................15
2. INTRODUCTION ...............................................................................................................18
2.1. Study Rationale .......................................................................................................18
2.2. Background .............................................................................................................18
2.2.1. Nonclinical Pharmacology..........................................................................18
2.2.2. Nonclinical Pharmacokinetics and Metabolism .........................................18
2.2.3. Nonclinical Safety ......................................................................................19
2.2.4. Clinical Overview.......................................................................................20
2.2.4.1. Clinical Safety...........................................................................20
2.2.4.2. Clinical Pharmacokinetics.........................................................20
2.3. Benefit/Risk Assessment.........................................................................................22
2.3.1. Risk Assessment.........................................................................................22
2.3.2. Benefit Assessment.....................................................................................24
2.3.3. Overall Benefit/Risk Conclusion................................................................24
3. OBJECTIVES AND ENDPOINTS.....................................................................................25
4. STUDY DESIGN.................................................................................................................25
4.1. Overall Design.........................................................................................................25
4.2. Scientific Rationale for Study Design.....................................................................27
4.2.1. Choice of Contraception/Barrier Requirements .........................................29
4.2.2. Collection of Retained Research Samples..................................................29
4.3. Justification for Dose ..............................................................................................29
4.4. End of Study Definition ..........................................................................................30
5. STUDY POPULATION......................................................................................................30
5.1. Inclusion Criteria.....................................................................................................31
5.1.1. Participants in All Groups ..........................................................................31
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5.1.2. Additional Inclusion Criteria for Participants with Normal Renal 
Fuction (Group 1) ............................................................................................32
5.1.3. Additional Inclusion Criteria for Participants with Impaired Renal 
Function (Groups 2-4)......................................................................................32
5.2. Exclusion Criteria....................................................................................................32
5.2.1. Participants in All Groups ..........................................................................32
5.2.2. Additional Exclusion Criteria for Participants with Normal Renal 
Function (Group 1) ..........................................................................................35
5.2.3. Additional Exclusion Criteria for Participants with Impaired Renal 
Function (Groups 2, 3, and 4)..........................................................................36
5.3. Lifestyle Considerations..........................................................................................36
5.3.1. Contraception..............................................................................................37
5.3.2. Meals and Dietary Restrictions...................................................................37
5.3.3. Caffeine, Alcohol, and Tobacco .................................................................38
5.3.4. Activity .......................................................................................................38
5.4. Screen Failures ........................................................................................................39
6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY.................................39
6.1. Study Intervention(s) Administered........................................................................39
6.1.1. Administration............................................................................................40
6.2. Preparation, Handling, Storage, and Accountability...............................................40
6.2.1. Preparation and Dispensing........................................................................41
6.3. Assignment to Study Intervention...........................................................................42
6.4. Blinding...................................................................................................................42
6.4.1. Blinding of Participants..............................................................................42
6.4.2. Blinding of Site Personnel..........................................................................42
6.4.3. Blinding of the Sponsor..............................................................................42
6.5. Study Intervention Compliance...............................................................................42
6.6. Dose Modification...................................................................................................42
6.7. Continued Access to Study Intervention After the End of the Study......................43
6.8. Treatment of Overdose............................................................................................43
6.9. Prior and Concomitant Therapy ..............................................................................43
6.9.1. Rescue Medicine.........................................................................................44
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7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL...........................................................................44
7.1. Discontinuation of Study Intervention ....................................................................44
7.2. Participant Discontinuation/Withdrawal From the Study.......................................44
7.2.1. Withdrawal of Consent...............................................................................45
7.3. Lost to Follow-up....................................................................................................45
8. STUDY ASSESSMENTS AND PROCEDURES...............................................................46
8.1. Administrative Procedures ......................................................................................46
8.2. Efficacy Assessments..............................................................................................47
8.3. Safety Assessments .................................................................................................47
8.3.1. Physical Examinations................................................................................47
8.3.2. Vital Signs ..................................................................................................48
8.3.2.1. Blood Pressure and Pulse Rate..................................................48
8.3.3. Electrocardiograms.....................................................................................48
8.3.4. Clinical Safety Laboratory Assessments ....................................................49
8.3.4.1. Fasting Fingerstick Blood Glucose (via Glucometer)...............50
8.3.4.2. Definition and Severity of Hypoglycemic Adverse Event........50
8.3.5. COVID-19 Specific Assessments...............................................................52
8.3.6. Pregnancy Testing ......................................................................................52
8.4. Adverse Events, Serious Adverse Events, and Other Safety Reporting .................52
8.4.1. Time Period and Frequency for Collecting AE and SAE Information.......53
8.4.1.1. Reporting SAEs to Pfizer Safety...............................................53
8.4.1.2. Recording Nonserious AEs and SAEs on the CRF...................53
8.4.2. Method of Detecting AEs and SAEs ..........................................................54
8.4.3. Follow-Up of AEs and SAEs......................................................................54
8.4.4. Regulatory Reporting Requirements for SAEs...........................................54
8.4.5. Environmental Exposure, Exposure During Pregnancy or 
Breastfeeding, and Occupational Exposure.....................................................55
8.4.5.1. Exposure During Pregnancy......................................................55
8.4.5.2. Exposure During Breastfeeding ................................................57
8.4.5.3. Occupational Exposure .............................................................57
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8.4.6. Cardiovascular and Death Events...............................................................57
8.4.7. Disease-Related Events and/or Disease-Related Outcomes Not 
Qualifying as AEs or SAEs..............................................................................57
8.4.8. Adverse Events of Special Interest.............................................................57
8.4.8.1. Lack of Efficacy........................................................................58
8.4.9. Medical Device Deficiencies......................................................................58
8.4.10. Medication Errors.....................................................................................58
8.5. Pharmacokinetics ....................................................................................................59
8.5.1. Plasma for Analysis of PF-07081532.........................................................59
8.5.2. Plasma for Determination of PF-07081532 Unbound Fraction..................59
8.5.3. Urine for Analysis of PF-07081532 ...........................................................60
8.6. Genetics...................................................................................................................61
8.6.1. Specified Genetics ......................................................................................61
8.6.2. Retained Research Samples for Genetics ...................................................61
8.7.2. Specified Gene Expression (RNA) Research .............................................62
8.7.3. Specified Protein Research.........................................................................62
8.7.4. Specified Metabolomic Research ...............................................................62
8.8. Immunogenicity Assessments.................................................................................62
8.9. Health Economics ...................................................................................................62
9. STATISTICAL CONSIDERATIONS ................................................................................62
9.1. Statistical Hypotheses .............................................................................................62
9.2. Analysis Sets ...........................................................................................................62
9.3. Statistical Analyses .................................................................................................63
9.3.1. General Considerations...............................................................................63
9.3.1.1. Analyses for PK Endpoints .......................................................63
9.3.2. Primary Endpoint(s) Analysis.....................................................................63
9.3.2.1. Definition of Endpoint(s) ..........................................................63
9.3.2.2. Main Analytical Approach........................................................65
9.3.2.3. Supplementary Analyses...........................................................65
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9.3.3. Secondary Endpoint Analysis - Safety Analyses........................................66
9.3.3.1. Electrocardiogram Analyses......................................................66
9.3.5. Other Analyses............................................................................................67
9.4. Interim Analyses .....................................................................................................67
9.5. Sample Size Determination.....................................................................................67
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS..........................................................................................................69
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations...............69
10.1.1. Regulatory and Ethical Considerations ....................................................69
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the 
Protocol or ICH GCP.........................................................................69
10.1.2. Financial Disclosure .................................................................................70
10.1.3. Informed Consent Process ........................................................................70
10.1.4. Data Protection .........................................................................................71
10.1.5. Committees Structure ...............................................................................71
10.1.5.1. Data Monitoring Committee ...................................................71
10.1.6. Dissemination of Clinical Study Data ......................................................72
10.1.7. Data Quality Assurance ............................................................................73
10.1.8. Source Documents....................................................................................74
10.1.9. Study and Site Start and Closure ..............................................................74
10.1.10. Publication Policy...................................................................................75
10.1.11. Sponsor’s Medically Qualified Individual..............................................76
10.2. Appendix 2: Clinical Laboratory Tests .................................................................77
10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-Up, and Reporting .....................................................................79
10.3.1. Definition of AE .......................................................................................79
10.3.2. Definition of an SAE ................................................................................80
10.3.3. Recording/Reporting and Follow-Up of AEs and/or SAEs During 
the Active Collection Period............................................................................82
10.3.4. Reporting of SAEs....................................................................................85
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10.4. Appendix 4: Contraceptive and Barrier Guidance ................................................87
10.4.1. Male Participant Reproductive Inclusion Criteria....................................87
10.4.2. Female Participant Reproductive Inclusion Criteria.................................87
10.4.3. Woman of Childbearing Potential ............................................................87
10.4.4. Contraception Methods.............................................................................88
10.5. Appendix 5: Genetics............................................................................................91
10.6. Appendix 6: Liver Safety: Suggested Actions and Follow-Up Assessments .......92
10.7. Appendix 7: Kidney Safety: Monitoring Guidelines ............................................94
10.7.1. Laboratory Assessment of Change in Kidney Function and 
Detection of Kidney Injury..............................................................................94
10.7.2. Age-Specific Kidney Function Calculation Recommendations...............94
10.7.2.1. Adults (18 Years and Above)—2021 CKD-EPI 
Equations14 ........................................................................................94
10.7.3. Adverse Event Grading for Kidney Safety Laboratory 
Abnormalities...................................................................................................94
10.8. Appendix 8: ECG Findings of Potential Clinical Concern ...................................95
10.9. Appendix 9: Prohibited Concomitant Medications That May Result in DDI.......97
10.10. Appendix 10: Other Prohibited Prior/Concomitant Medications......................100
10.11. Appendix 11: Abbreviations .............................................................................101
11. REFERENCES ................................................................................................................105
LIST OF TABLES
Table 1.
Renal Function Categories based on eGFR..............................................26
Table 2.
Plasma PK Parameters..............................................................................64
Table 3.
Urine PK Parameters ................................................................................65
Table 4.
Expected Widths of the 90% CIs (with 80% Coverage Probability) 
for Different Possible Estimated Effects ..................................................67
Table 5.
Protocol -Required Safety Laboratory Assessments ................................77
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1. PROTOCOL SUMMARY 
1.1. Synopsis 
Protocol Title: 
A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Pharmacokinetics 
of PF-07081532 in Adult Participants with Type 2 Diabetes Mellitus with Varying Degrees 
of Renal Impairment Relative to Participants without Renal Impairment.
Brief Title:
A Study to Investigate the Effects of Renal Impairment on the Pharmacokinetics of 
PF-07081532.
Regulatory Agency Identification Number(s):
US IND Number:
147045
EudraCT/CTIS Number:
Not Applicable (N/A)
ClinicalTrials.gov ID:  
Not available
Pediatric Investigational Plan Number:
N/A
Protocol Number:
C3991007
Phase:
1
Rationale:
The primary purpose of this study is to characterize the effect of varying degrees of renal 
impairment on the PK of a single oral dose of PF-07081532 in adult participants with T2DM
compared to participants with T2DM with normal renal function.
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Objectives and Endpoints:
Objectives
Endpoints
Primary: 
Primary:
•
To compare the PK of PF-07081532 following 
administration of a single oral dose in adult participants 
with T2DM and varying degrees of renal impairment 
relative to age- and body weight-matched participants 
with T2DM, without renal impairment.
• Plasma: Cmax, AUCinf, AUClast*, fu, Cmax,u, 
AUCinf,u and AUClast,u*, as data permit.
Secondary: 
Secondary:
•
To evaluate the safety and tolerability of a single oral 
dose of PF-07081532 when administered to adult 
participants with T2DM and varying degrees of renal 
impairment relative to age- and body weight-matched 
participants with T2DM, without renal impairment.
• Assessment of treatment emergent AEs, 
clinical laboratory abnormalities, vital 
signs, ECG parameters.
* AUClast and AUClast,u will be treated as primary endpoints if data do not permit robust estimation of AUCinf
and AUCinf,u, otherwise they will be treated as tertiary endpoints.
Overall Design:
This is an open-label, single-dose, parallel-group study to investigate the effect of varying 
degrees of renal function on the PK of PF-07081532 after a single, oral 20 mg dose 
administered in the fed state (standard, non-high fat breakfast). Safety and tolerability will be 
evaluated throughout the study.
Participants with T2DM with normal renal function, and with mild, moderate, and severe 
renal impairment, will be enrolled into 1 of 4 groups. This study will permit enrollment of 
2-4 participants on dialysis, as part of the severe renal impairment group, to assist in 
recruitment of patients with more advanced renal impairment and to permit assessment of the 
PK of PF-07081532 in participants with the highest degree of renal impairment.
Number of Participants:
Approximately 32 participants with T2DM and varying degrees of renal function will be 
enrolled to receive study intervention. If recruitment of participants with eGFR <30 mL/min 
proves prohibitive, the number of participants to be enrolled in the group with severe 
impairment may be flexible (6-8 participants). 
Study Population:
Key inclusion and exclusion criteria are listed below:
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Inclusion Criteria
Participants must meet the following key inclusion criteria to be eligible for enrollment into 
the study:
•
Stable renal function (for participants not on dialysis) defined as ≤25% difference 
between 2 measurements of eGFR (calculated by the sponsor-identified laboratory 
using the 2021 CKD-EPI Scr-Scys combined equation as described in Section 4.1) 
obtained at Screening visits S1 and S2. The average of the 2 eGFR values obtained 
from S1 and S2 will be used for study enrollment and assignment to appropriate renal 
function group (see Table 1). Note: participants on dialysis will be placed in Group 4 
regardless of eGFR from S1 and S2 (S2 is optional for dialysis participants, only).
•
Meet eGFR criteria for inclusion in group with:
•
Normal renal function (≥90 mL/min); or 
•
Mild (60-89 mL/min), moderate (30-59 mL/min), or severe (<30 mL/min) renal 
impairment.
•
A prior diagnosis of T2DM with an HbA1c ≥6% and ≤10.5%, at Screening visit S1, 
confirmed by a single repeat, if deemed necessary.
•
Male and female participants ≥18 years of age (or the minimum country-specific age 
of consent if >18), at the time of providing informed consent. 
•
BMI of 17.5 to 45.4 kg/m2, inclusive; and a total body weight >50 kg (110 lb), at 
Screening visit S1. 
•
The group of participants with normal renal function should, at screening (S1), meet 
the demographic-matching criteria, including body weight within ±15 kg and age 
within ±10 years, of the average of the pooled renal impairment groups, as provided 
by the sponsor.
Key Exclusion Criteria
Participants with any of the following characteristics/conditions will be excluded:
•
Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes, or history of 
diabetic ketoacidosis.
•
Any condition possibly affecting drug absorption (eg, prior bariatric surgery, 
gastrectomy, ileal resection). NOTE: Participants who have undergone 
cholecystectomy and/or appendectomy are eligible for this study as long as the 
surgery occurred more than 6 months prior to Screening visit S1.
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•
Any malignancy not considered cured (except basal cell carcinoma and squamous cell 
carcinoma of the skin); a participant is considered cured if there has been no evidence 
of cancer recurrence in the previous 5 years.
•
Personal or family history of MTC or MEN2, or participants with suspected MTC per 
the investigator’s judgement.
•
History of acute pancreatitis within 6 months before Screening visit S1 or any history 
of chronic pancreatitis.
•
Urinary incontinence.
•
Participants with acute renal disease.
•
Renal allograft recipients.
•
Participants who have previously received a kidney, liver, or heart transplant.
•
At Screening (S1), standard 12-lead ECG that demonstrates a clinically relevant 
abnormality that requires further diagnostic evaluation or intervention (eg, new, 
clinically relevant arrhythmia, conduction disturbance, findings suggestive of 
ischemia). A potential participant whose pre-dose ECG (on Day 1, 0 hour) 
demonstrates a clinically relevant abnormality that requires further diagnostic 
evaluation or intervention will be considered a screen failure.
•
For females, pregnancy, as indicated by a positive serum pregnancy test at screening 
and/or positive urine pregnancy test in WOCBP at Day -1. 
•
Participants with ANY of the following abnormalities in clinical laboratory tests at 
Screening (S1), as assessed by the study-specific local laboratory and confirmed by a 
single repeat test, if deemed necessary:
•
Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's 
syndrome may have direct bilirubin measured and would be eligible for this study 
provided the direct bilirubin level is ≤ ULN.
•
Fasting C-peptide <0.8 ng/mL.
•
FPG >270 mg/dL (15 mmol/L).
•
In addition, for participants with normal renal function: 
•
Any of the following abonormalities in clinical laboratory tests at Screening, as 
assessed by the sponsor-approved laboratory and confirmed by a single repeat 
test, if deemed necessary:
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•
AST ≥1.5x ULN; or
•
ALT ≥1.5x ULN.
•
At Screening (S1), seated SBP ≥160 mmHg and/or DBP ≥100 mmHg after ≥5 
minutes of seated rest. If BP is ≥160 mm Hg (systolic) or ≥100 mm Hg 
(diastolic), the BP should be repeated 2 more times and the average of the 3 BP 
values should be used to determine the participant’s eligibility
•
In addition, for participants with impaired renal function: 
•
Any of the following abnormalities in clinical laboratory tests at Screening, as 
assessed by the sponsor-identified laboratory and confirmed by a single repeat 
test, if deemed necessary:
•
AST ≥2x ULN or
•
ALT ≥2x ULN
•
At Screening, Day -1 or Day 1, persistent severe, uncontrolled hypertension, as 
defined in the study protocol.
Study Arms and Duration:
Eligible participants with T2DM will be enrolled into 1 of 4 groups based on eGFR 
(calculated using the 2021 CKD-EPI Scr-Scys combined equation ): 
1. Normal renal function (≥90 mL/min).
2. Mild (60-89 mL/min) renal impairment.
3. Moderate (30-59 mL/min) renal impairment.
4. Severe (<30 mL/min) renal impairment.
A single oral 20 mg dose of PF-07081532 will be administered. For individual participants, 
the total study duration from Screening visit S1 to the Follow-up contact will be a minimum 
of approximately 6 weeks and a maximum of up to approximately 10 weeks. The study 
consists of an initial screening period of up to 28 days, a 7-day inpatient stay at the CRU 
which includes administration of a single oral dose of PF-07081532, and a follow up contact 
that will occur 28-35 days after PF-07081532 administration. 
PF-07081532 will be supplied by Pfizer as 20 mg tablets in open-label bulk bottles along 
with individual dosing containers, as necessary, for unit dosing. Participants will take 
1 PF-07081532 20-mg tablet orally with the morning meal. 
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Study Intervention(s)
Intervention Name
PF-07081532
Arm Name
(group of participants receiving a specific treatment or no treatment)
Group 1, Group 2, 
Group 3, Group 4
Unit Dose Strength(s)
20 mg 
Route of Administration
Oral
Use
Experimental
IMP or NIMP/AxMP
IMP 
Statistical Methods:
A sample size of approximately 32 participants (approximately 8 participants per group, with 
varying degrees of renal function in each of the 4 groups) has been selected to provide 
sufficient precision to detect a 1.5-fold difference in AUCinf between each Test group (with 
renal impairment) and the Reference group (without renal impairment). 
The effect of varying degrees of renal impairment on PK parameters will be assessed by 
constructing 90% CIs around the estimated difference between each of the Test (renal 
impaired) groups and the Reference (without renal impairment) group. ANOVA will be used 
to compare the natural log-transformed AUCinf, AUClast, Cmax, fu, AUCinf,u, AUClast,u and 
Cmax,u of PF-07081532 for each of the renal impairment groups (Test) to the group without 
renal impairment (Reference), as data permit. The ANOVA model will include all groups. 
Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs will 
be obtained from the model. These will be exponentiated to provide estimates of the ratio of 
adjusted geometric means (Test/Reference) and corresponding 90% CIs for the ratios.
All safety analyses will be performed on the safety population. AEs, ECGs, BP, pulse rate, 
and safety laboratory data will be reviewed and summarized on an ongoing basis during the 
study to evaluate the safety of participants. Any clinical laboratory, ECG, BP, and pulse rate 
abnormalities of potential clinical concern will be described. Safety data will be presented in 
tabular and/or graphical format and summarized descriptively, where appropriate, following 
sponsor standards.
Ethical Considerations:
A single dose of PF-07081532 is not expected to provide any clinical benefit to study
participants. This study is designed primarily to characterize the effect of varying degrees of 
renal impairment on the PK of PF-07081532. Results from this study will be used in 
conjunction with collective safety, tolerability, efficacy, and PK/PD (pharmacodynamic) data 
from other PF-07081532 studies to provide recommendations on dosing for participants with 
varying degrees of renal function.
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1.2. Schema
1.3. Schedule of Activities
The SoA table provides an overview of the protocol visits and procedures. Refer to the 
STUDY ASSESSMENTS AND PROCEDURES section (Section 8) of the protocol for 
detailed information on each procedure and assessment required for compliance with the 
protocol. 
The investigator may schedule visits (unplanned visits) in addition to those listed in the SoA
table, in order to conduct evaluations or assessments required to protect the well-being of the 
participant.
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a.
Screening takes place over 2 outpatient visits (S1 and S2), separated by at least 72 hrs. S1 must be within the 28 days prior to D1 dose administration. S2 is 
to demonstrate stable renal function and is optional for patients on dialysis, only.
b.
Follow-up visit to be performed as telephone contact and must occur in the window of 28 to 35 days  (ie, Day 29-36) from administration of study 
intervention. A clinic visit may be performed in place of telephone contact, if deemed necessary by the investigator eg, for follow-up of abnormal laboratory 
tests and/or open AEs.
c.
Assessment of risk for, symptoms of or testing for COVID-19 may be performed at screening, admission to the CRU and/or at other times during the study 
at investigator discretion and according to local site policies.
d.
In confirmation of appropriate contraception use only.
e.
Complete PE at Screening visit S1; at all other timepoints limited PE, at investigator discretion (see Section 8.3.1).
f.
If done around the time of a blood draw, ECG and vital signs should be collected before the blood draw. ECG and vital signs on Day 1 at Time 0H must be 
done before collection of the pre-dose blood samples. If an IV catheter is utilized for blood sample collections, ECGs and vital sign assessments (BP and 
pulse rate) should be collected before insertion of the catheter.
g.
Glucometer measures will be taken before breakfast in participants with T2DM on all days while inpatient. Additional measurements may be made at the 
discretion of the investigator.
h.
Meals/snacks will be provided on all days while inpatient as per Section 5.3.2. While inpatient, meal and snack times should match nominal time of 
approximately 0H, 4H, 6H (optional), 10H, 14H (optional) relative to dosing on Day 1. Meals/snacks on Day -1 must be timed such that there is at least an 
8 hour fast prior to collection of the pre-dose PK sample on Day 1 (see Section 5.3.2).
i.
Dosing will occur within approximately 10 minutes of completion of breakfast on Day 1.
j.
Safety related laboratory tests may be collected on Day -1 at investigator discretion. If performed, results must be reviewed prior to dosing and must reflect 
the participant to be in stable medical condition. Total bile acids, lipase, and amylase at Screening only. 
k.
Samples collected at Time 0 on Day 1 must be collected pre-dose.
l.
eGFR determination will be performed by the laboratory using the 2021 CKD-EPI Scr-Scys combined equation, as described in Section 4.1 and Appendix 7.
m. If not collected on the designated collection day, collect at the next available time point when biospecimens are being collected in conjunction with a 
participant visit.
n.
Blank pre-dose urine sample to be collected within 24H prior to dosing. Urine should be collected at intervals of 0-6, 6-12 and 12-24 hours after dosing. See 
Section 8.5.3. If participant is on dialysis and has no urine output, no urine PK samples will be collected. 
o.
For a participant on dialysis who is anuric only, an alternative method (eg, saliva) for urine drug testing may be used.
p.
For a participant on dialysis who is anuric only, urinalysis is not required to be collected.
q.
Test result must be reviewed and deemed acceptable (ie, negative) to continue participation in the study. For a participant on dialysis who is anuric only, an 
alternative method (eg, blood) for pregnancy testing may be used.
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Potential Risk of Clinical Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
ranges, and, throughout the study, no AEs or 
clinical symptoms related to vital sign parameters 
were reported.
Other potential risks associated with long-term 
dosing of marketed GLP-1R agonists include 
thyroid C-cell tumors, pancreatitis, impairment in 
renal function, diabetic retinopathy complications, 
and acute gallbladder disease 
These potential risks are based on product labeling 
for injectable GLP-1R agonists (ie, liraglutide, 
dulaglutide, exenatide and semaglutide); additional 
information is provided in the IB.
The single dose and dose level administered in 
this study minimize any potential risk. 
Study includes inpatient monitoring of the 
participants following administration of a single 
dose of the IP.
Participants with a personal or family history of 
MTC or MEN2; with acute pancreatitis or a 
history of chronic pancreatitis are not eligible for 
study entry. 
Other
Risk of COVID-19 exposure during study
During the pandemic, study participants could be 
exposed to the SARS-CoV-2 virus during study 
participation. This could lead to increased health 
risk for this participant and others in the study.
Assessment of risk for, symptoms of or testing for 
COVID‑19 may be performed at screening, 
admission to the CRU and/or at other times 
during the study at investigator discretion and 
according to local site policies.
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2.3.2. Benefit Assessment
A single dose of PF-07081532 is not expected to provide any clinical benefit to study
participants. This study is designed primarily to characterize the effect of varying degrees of 
renal impairment on the PK of PF-07081532 to support further clinical development of 
PF-07081532 as a potential treatment of T2DM. Results from this study will be used in 
conjunction with collective safety, tolerability, efficacy, and PK/PD data from other 
PF‑07081532 studies to develop dosing recommendations for the target patient population 
with varying degrees of renal function.
2.3.3. Overall Benefit/Risk Conclusion
In line with the clinical profile of marketed GLP-1R agonists, the most frequently reported 
AEs in the 2 completed studies with PF-07081532 administration have been in the 
Gastrointestinal Disorders SOC (Section 2.2.4). In addition, as has been reported for 
marketed GLP-1R agonists, modest increases in heart rate have been observed with 
PF-07081532 administration, with most heart rate values within the normal range. Based on 
available clinical data (Section 2.2.4 and current IB), a single 20 mg PF-07081532 dose is 
anticipated to be safe and well tolerated, including in participants with varying degrees of 
renal impairment, even if increased plasma concentrations were to be observed (Section 4.3).
Based on the profile of PF-07081532 observed in nonclinical and clinical studies to date, and 
taking into account the measures to minimize risk to study participants, the potential risk to 
the participants in this study is deemed to be minimal and is justified by the anticipated 
benefits that may be afforded to patients with varying degrees of renal impairment receiving 
PF-07081532 in the future.
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A total of approximately 32 participants with T2DM and varying degrees of renal function 
will be dosed in the study as shown in Table 1. If recruitment of participants with eGFR 
<30 mL/min proves prohibitive, the number of participants to be enrolled in the group with 
severe impairment may be flexible (6-8 participants). This study will permit enrollment of 
2-4 participants on dialysis, as part of the severe renal impairment group, to assist in 
recruitment of patients with more advanced renal impairment and to permit assessment of the 
PK of PF-07081532 in participants with the highest degree of renal impairment. Since 
PF-07081532 has a high unbound non-renal clearance and a large unbound volume of 
distribution (given a fu of 0.000376 in humans), dialysis is not expected to significantly 
impact the clearance of PF-07081532 and therefore the dialysis clearance of PF-07081532 
will not be characterized in this study. Thus, Day 1 (per the SoA) will occur in dialysis 
patients on a day in which dialysis is not administered.
Table 1.
Renal Function Categories based on eGFR
Group
Renal Impairment
No. of Participants
eGFRa
(mL/min)
1
None (Normal Renal Function)
8
≥90
2
Mild
8
60-89
3
Moderate
8
30-59
4
Severe 
8b
<30
a.
See text below regarding determination of eGFR for study enrollment and group placement. 
Note: participants on dialysis will be placed in Group 4 regardless of unnormalized eGFR value.
b.
2-4 participants on dialysis are permitted (not required). If recruitment proves to be prohibitive, study 
may dose 6-8 participants with severe renal impairment.
Screening will occur within 28 days of the first dose of study intervention on Day 1. All 
participants will provide informed consent and undergo Screening evaluations to determine 
their eligibility.
At each of the 2 Screening visits (S1 and S2), an estimate of eGFR will be determined for 
each participant as described in the steps below:
1. Calculate eGFR using the 2021 CKD-EPI Scr-Scys combined equation (see 
Appendix 7).
2. Multiply this eGFR value by each participant’s ratio of BSA/1.73 to obtain the 
BSA-unnormalized eGFR value as shown below:
•
eGFR (mL/min) = eGFR (mL/min/1.73m2) * [BSA (m2) / 1.73]
The BSA of an individual will be calculated using the following equation:6
•
BSA (m2) = [Weight(kg)0.425 × Height(cm)0.725] × 0.007184
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The average of the 2 BSA-unormalized eGFR values from Screening visits S1 and S2 will 
be used for study enrollment and group placement using the categories presented in Table 1. 
Participants who are not on dialysis must have stable renal function to enter the study, 
defined as ≤25% difference between 2 measurements of BSA-unnormalized eGFR obtained 
from the 2 Screening visits, S1 and S2 as listed in the SoA. Visit S2 is optional for 
participants on dialysis, who will be placed in Group 4 regardless of eGFR value.
Staged Enrollment of Study Groups
•
Participants will be dosed in a staged manner such that those with moderate and 
severe renal impairment (Groups 3 and 4) will be enrolled first. 
•
Recruitment of participants with mild renal impairment (Group 2) will initiate when 
approximately 50% of the participants in Groups 3 and 4 have been dosed. 
Approval from the sponsor is required before proceeding with recruitment for Group 2. 
•
An average value for age and weight for Groups 2, 3, and 4 will be determined and 
participants in Group 1 will be recruited to match the average demographics (at a 
minimum, age and weight, and as much as practically possible gender) across the 
pooled Groups 2-4. 
•
Therefore, recruitment of participants without renal impairment (Group 1) may start 
when approximately 75% of total participants across Groups 2-4 (ie, approximately 
17-18 participants) have been dosed. 
Approval from the sponsor is required before proceeding with recruitment for Group 1. 
Refer to Section 1.2 for the Study Schema. For individual participants, the total study 
duration from Screening visit S1 to the Follow-up contact will be a minimum of 
approximately 6 weeks and a maximum of up to approximately 10 weeks. The study consists 
of an initial screening period of up to 28 days, a 7-day inpatient stay at the CRU which 
includes administration of a single oral dose of PF‑07081532, and a follow-up contact (or site 
visit, per discretion of the PI) that will occur 28-35 days after PF‑07081532 administration on 
Day 1.
Participants who discontinue from the study before completing all assessments may be 
replaced at the discretion of the investigator and sponsor.
4.2. Scientific Rationale for Study Design
The purpose of this study is to characterize the effect of varying degrees of renal impairment 
on the PK, safety and tolerability of PF-07081532. PF-07081532 is an oral GLP-1R agonist 
that is currently being investigated as a chronic therapy to improve glycemic control in adult 
participants with T2DM. CKD occurs in 20-40% of patients with diabetes and may be 
present at the time of diagnosis of T2DM.7
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In Study C3991001, a single dose of 30 mg was very well tolerated with an AE profile that 
did not differ from placebo. In the same study, single ascending doses up to 200 mg were 
tested and were considered safe and had a tolerability profile in line with expectations for the 
MOA, with the majority of AEs being mild in severity and in the GI SOC (with nausea and 
vomiting the most frequently observed). For participants that experienced vomiting 
(observed at the 100 and 200 mg dose levels, with increased incidence at 200 mg), this 
generally occurred after the attainment of Cmax and with no apparent impact on PF-07081532 
exposure. In addition, the dose proposed in the current study (20 mg) reflects adequate safety 
margins compared to nonclinical toxicity studies. After accounting for species differences in 
protein binding, this dose represents an exposure in participants with healthy renal function 
that is approximately 
, lower than the 
exposure observed at the NOAEL in the pivotal 9-month toxicology study in monkeys 
(Section 2.2.3). Given the above it is anticipated that potential increases in plasma exposure 
in participants with varying degrees of renal impairment in the current study, if encountered, 
are not anticipated to pose an undue safety risk. 
Although doses up to 260 mg QD may be evaluated in future clinical studies with 
PF-07081532, the proposed dose of 20 mg is viewed as appropriate for this study, given the 
potential of increased exposures in participants with renal impairment. Since no greater than 
dose-proportional increases in exposure of PF-07081532 have been observed over the range 
of clinical doses tested so far (up to single dose of 200 mg and up to 180 mg QD), the results 
from this study may be used to extrapolate and inform the effect of renal impairment on PK 
over doses exceeding 20 mg. 
4.4. End of Study Definition
The end of the study is defined as the date of follow-up as shown in the SoA for the last 
participant in the trial globally.
A participant is considered to have completed the study if they have completed all phases of 
the study, including the follow-up (telephone contact or onsite visit per investigator 
discretion) as shown in the SoA.
5. STUDY POPULATION
This study can fulfill its objectives only if appropriate participants are enrolled, including 
participants across diverse and representative racial and ethnic backgrounds. Use of a 
prescreening tool is utilized for study recruitment purposes, it will include collection of 
information that reflects the enrollment of a diverse participant population including, where 
permitted under local regulations, age, sex, and race, and ethnicity. The following eligibility 
criteria are designed to select participants for whom participation in the study is considered 
appropriate. All relevant medical and nonmedical conditions should be taken into 
consideration when deciding whether a particular participant is suitable for this protocol.
Prospective approval of protocol deviations to recruitment and enrollment criteria, also 
known as protocol waivers or exemptions, is not permitted.
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5.1. Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
5.1.1. Participants in All Groups
Type of Participant and Disease Characteristics:
1. Stable renal function (for participants not on dialysis) defined as ≤25% difference 
between 2 measurements of BSA-unnormalized eGFR (calculated by the 
sponsor-approved laboratory using the 2021 CKD-EPI Scr-Scys combined equation
as described in Section 4.1) obtained at Screening visits S1 and S2. The average of 
the 2 eGFR values obtained from S1 and S2 will be used for study enrollment and 
assignment to appropriate renal functiongroup (see Table 1. Note: participants on 
dialysis will be placed in Group 4 regardless of eGFR value (S2 is optional for 
dialysis participants, only).
2. A prior diagnosis of T2DM with an HbA1c ≥6% and ≤10.5%, at Screening visit S1, 
confirmed by a single repeat, if deemed necessary.
Age and Sex:
3. Male and female participants ≥18 years of age (or the minimum country-specific age 
of consent if >18), at the time of providing informed consent.  
•
Women may be of child-bearing potential, however, cannot be pregnant, 
breastfeeding, or planning to become pregnant while participating in the study.
Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female 
(Section 10.4.2) participants.
Weight
4. BMI of 17.5 to 45.4 kg/m2, inclusive; and a total body weight >50 kg (110 lb), at 
Screening visit S1. 
Other Inclusion Criteria:
5. Stable concomitant medications for the management of medical conditions relevant to 
an individual participant’s medical history. Participants receiving fluctuating 
concomitant medications/treatments may be considered, on a case-by-case basis with 
approval from sponsor, if the underlying disease is stable.
6. Capable of giving signed informed consent as described in Appendix 1, which 
includes compliance with the requirements and restrictions listed in the ICD and in 
this protocol.
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7. Participants who are willing and able to comply with all scheduled visits, treatment 
plan, laboratory tests, lifestyle considerations (as described in Section 5.3), and other 
study procedures.
5.1.2. Additional Inclusion Criteria for Participants with Normal Renal Fuction
(Group 1)
1. Normal renal function (mean eGFR ≥90 mL/min) based on an average of measures 
from Screening visits S1 and S2 (eGFR should be calculated using the 2021
CKD-EPI Scr-Scys combined equation, as described in Section 4.1).
2. Demographically comparable to participants with impaired renal function at 
Screening visit S1:
a.
A body weight within ±15 kg of the mean body weight of the pooled renal 
impairment groups (Groups 2, 3 and 4), as provided by sponsor;
b. An age within ±10 years of the mean age of the pooled renal impairment groups 
(Groups 2, 3 and 4), as provided by sponsor;
c.
Attempts will be made to ensure that the male to female distribution in Group 1 
is comparable to that in the pooled renal impairment groups (Groups 2, 3 and 4).
5.1.3. Additional Inclusion Criteria for Participants with Impaired Renal Function 
(Groups 2-4)
1. Meet the eGFR criteria listed for Groups 2, 3, or 4 (for participants not on dialysis) in 
Table 1 based on an average of measures from Screening visits S1 and S2 (eGFR 
should be calculated using the 2021 CKD-EPI Scr-Scys combined equation, as 
described in Section 4.1).
2. For Group 4 participants on dialysis only, participants must have required 
hemodialysis for at least 6 weeks prior to Screening visit S1 and need dialysis 
sessions 3 times per week. Note: participants on dialysis will be placed in Group 4 
regardless of eGFR from S1 and S2 (S2 is optional for dialysis participants, only).
5.2. Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
5.2.1. Participants in All Groups
Medical Conditions:
1. Any condition possibly affecting drug absorption (eg, prior bariatric surgery, 
gastrectomy, ileal resection).
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•
NOTE: Participants who have undergone cholecystectomy and/or appendectomy
are eligible for this study as long as the surgery occurred more than 6 months 
prior to Screening visit S1.
2. Any malignancy not considered cured (except basal cell carcinoma and squamous cell 
carcinoma of the skin); a participant is considered cured if there has been no evidence 
of cancer recurrence in the previous 5 years.
3. Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes, or history of 
diabetic ketoacidosis.
4. History of myocardial infarction, unstable angina, arterial revascularization, stroke, 
New York Heart Association Functional Class II-IV heart failure, or transient 
ischemic attack within 3 months of Screening visit S1.
5. Personal or family history of MTC or MEN2, or participants with suspected MTC per 
the investigator’s judgement.
6. History of acute pancreatitis within 6 months before Screening visit S1 or any history 
of chronic pancreatitis.
7. Urinary incontinence.
8. Participants with acute renal disease.
9. Renal allograft recipients.
10. Participants who have previously received a kidney, liver, or heart transplant.
11. Other medical or psychiatric condition including recent (within the past year) or 
active suicidal ideation/behavior or laboratory abnormality or other conditions or 
situations related to COVID-19 pandemic (eg, contact with positive case) that may 
increase the risk of study participation, or, in the investigator’s judgment, make the 
participant inappropriate for the study.
NOTE: Participants who have chronic conditions other than T2DM (for example, 
hypercholesterolemia or hypertension) but are controlled by either diet or stable doses 
of 2 or fewer medications may be included (for example, a participant with 
hypercholesterolemia on appropriate treatment is eligible). See Section 6.9 for further 
information on concomitant medications.
Prior/Concomitant Therapy:
12. Use of prohibited prior/concomitant therapies as outlined in Section 6.9, Appendix 9
and Appendix 10.
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Prior/Concurrent Clinical Study Experience:
13. Previous administration with an IP (drug or vaccine) within 30 days (or as determined 
by the local requirement) or 5 half-lives preceding the first dose of study intervention
used in this study (whichever is longer). Investigational products 
 
 are prohibited within 14 days plus 
5 half-lives prior to the dose of study intervention.
14. Known prior participation (ie, received at least 1 dose of study intervention) in a 
study involving PF-07081532 or known intolerance to a GLP-1R agonist.
Diagnostic Assessments:
15. At Screening (S1), standard 12-lead ECG that demonstrates a clinically relevant 
abnormality that requires further diagnostic evaluation or intervention (eg, new, 
clinically relevant arrhythmia, conduction disturbance, findings suggestive of 
ischemia). A potential participant whose pre-dose ECG (on Day 1, 0 hour) 
demonstrates a clinically relevant abnormality that requires further diagnostic 
evaluation or intervention will be considered a screen failure.
16. A positive drug test at Screening (S1). However, participants in Groups 2-4, only, 
who have been medically prescribed medications, eg. opiates, opioids, cannabinoids, 
benzodiazepines, methylphenidate (or similar), and report the use of these drugs to 
the investigator at the screening visit may be allowed to participate, after approval 
from the sponsor, and if in line with protocol specifications regarding prohibited 
medications (see Section 6.9, Appendices 9 and 10). 
NOTE: Repeat drug testing to assess study eligibility is not permitted in this study.
17. At screening or Day -1, a positive breath alcohol test, as assessed using kits approved 
by sponsor; for the screening test, a single repeat (which may be on a separate day)
before Day -1 is permitted to assess eligibility, if needed.
18. For females, pregnancy, as indicated by a positive serum pregnancy test at screening 
and/or positive urine pregnancy test in WOCBP at Day -1. 
19. Participants with ANY of the following abnormalities in clinical laboratory tests at 
Screening (S1), as assessed by the study-specific local laboratory and confirmed by a 
single repeat test, if deemed necessary: 
•
Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's 
syndrome may have direct bilirubin measured and would be eligible for this study 
provided the direct bilirubin level is ≤ULN.
•
Fasting C-peptide <0.8 ng/mL.
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•
FPG >270 mg/dL (15 mmol/L).
20. If performed at investigator discretion, safety related laboratory tests collected on 
Day -1, upon review prior to dosing reflect the participant not to be in stable medical 
condition.
Other Exclusion Criteria:
21. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or 
more within 60 days prior to dosing and until the Follow-up contact.
22. History of sensitivity to heparin or heparin-induced thrombocytopenia, only if heparin 
is used to flush IV catheters used during serial blood collections.
23. History of regular alcohol consumption exceeding 7 drinks/week for female 
participants or 14 drinks/week for male participants (1 drink = 5 ounces [150 mL] of 
wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 
6 months before Screening visit S1.
24. Investigator site staff directly involved in the conduct of the study and their family 
members, site staff otherwise supervised by the investigator, and sponsor and sponsor 
delegate employees directly involved in the conduct of the study and their family 
members.
5.2.2. Additional Exclusion Criteria for Participants with Normal Renal Function
(Group 1)
Participants presenting with any of the following will not be included in the study:
1. Any of the following abnormalities in clinical laboratory tests at Screening, as 
assessed by the sponsor-approved laboratory and confirmed by a single repeat test, if 
deemed necessary:
•
AST level ≥1.5 × ULN or
•
ALT level ≥1.5 × ULN.
2. At Screening (S1), seated SBP ≥160 mmHg and/or DBP ≥100 mmHg after 
≥5 minutes of seated rest. If BP is ≥160 mm Hg (systolic) or ≥100 mm Hg (diastolic), 
the BP should be repeated 2 more times and the average of the 3 BP values should be 
used to determine the participant’s eligibility.
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5.2.3. Additional Exclusion Criteria for Participants with Impaired Renal Function 
(Groups 2, 3, and 4)
Participants presenting with any of the following will not be included in the study: 
1. At Screening, Day -1 or Day 1, persistent severe, uncontrolled hypertension as 
outlined below: 
•
Groups 2, 3 and 4 at Screening (S1) or Day -1: seated SBP ≥180 mmHg or 
DBP ≥105 mmHg after ≥5 minutes of seated rest, with a single repeat permitted at 
each of these 2 visits to assess eligibility, if needed;  if done, the repeat 
assessment overrides initial results.
NOTE: For participants with SBP ≥160 and ≤179 mmHg or DBP ≥100 and ≤104
mmHg at Screening, the period between Screening and Day ‑1 may be used to 
refine the doses of the agents used for management of BP with the aim of having 
stable BP by Day -1. 
•
Groups 2 and 3 only, at Day 1: seated SBP ≥160 mmHg or DBP ≥100 mmHg 
after ≥5 minutes of seated rest, with a single repeat permitted to assess eligibility, 
if needed; if done, the repeat assessment overrides initial results.
•
Group 4 only, at Day 1: seated SBP ≥160 mmHg or DBP ≥105 mmHg after 
≥5 minutes of seated rest, with a single repeat permitted to assess eligibility, if 
needed; if done, the repeat assessment overrides initial results. 
2. Any of the following abnormalities in clinical laboratory tests at Screening, as 
assessed by the sponsor-identified laboratory and confirmed by a single repeat test, if 
deemed necessary:
•
AST ≥2 × ULN or
•
ALT level ≥2 × ULN.
3. For participants in Group 4 on dialysis only: Hemodynamic instability during or at 
the conclusion of dialysis during the 2 weeks prior to dosing on Day 1, as marked by 
symptomatic hypotension. 
5.3. Lifestyle Considerations
After confirmation of eligibility, participants will be instructed to maintain the guidelines 
described below for the duration of participation in the study.
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5.3.1. Contraception
The investigator or their designee, in consultation with the participant, will confirm that the 
participant is utilizing an appropriate method of contraception for the individual participant 
from the permitted list of contraception methods (see Appendix 4, Section 10.4.4) and will 
confirm that the participant has been instructed in its consistent and correct use. At time 
points indicated in SoA, the investigator or designee will inform the participant of the need to 
use highly effective contraception consistently and correctly and document the conversation 
and the participant’s affirmation in the participant’s chart. Participants need to affirm their 
consistent and correct use of at least 1 of the selected methods of contraception, considering 
that their risk for pregnancy may have changed since the last visit. 
In addition, the investigator or designee will instruct the participant to call immediately if the 
selected contraception method is discontinued and document the requirement to use an 
alternate protocol-specified method, including if the participant will no longer use abstinence 
as the selected contraception method, or if pregnancy is known or suspected in the participant 
or partner.
5.3.2. Meals and Dietary Restrictions
•
Participants must abstain from all food and drink (except water) at least 4 hours prior 
to all fasting clinical laboratory evaluations and at least 8 hours prior to the collection 
of the pre-dose PK sample on Day 1.
•
Water may be consumed as desired (ad libitum).
•
On Day 1, following an overnight fast of at least 8 hours, participants should begin a 
standard, non-high fat breakfast approximately 30 minutes prior to PF-07081532 
administration. The breakfast will be consumed over approximately a 20-minute 
period with PF-07081532 administered within approximately 10 minutes after
completion of the meal. Participants will be encouraged to complete the entire 
breakfast. There will be no water restrictions prior to dosing.
•
Otherwise, while inpatient, all meals will be standardized as follows: 
•
Standard morning meal, lunch, an optional afternoon snack, an evening meal, and 
an optional evening snack will be provided at a similar clock time to the clock 
time when these meals are provided relative to dosing on Day 1 while inpatient 
(ie, approximately 0H, 4H, 6H [optional snack], 10H, and 14H [optional snack]).
•
The total daily nutritional composition should be approximately 
55% carbohydrate, 30% fat and 15% protein. The nutritional macronutrient 
composition consumed by each participant should be maintained, as much as 
practically possible.
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•
The daily caloric intake per participant should not exceed approximately 
3,200 kcal.
•
Participants will refrain from consuming red wine, grapefruit, or 
grapefruit-related citrus fruits (eg, Seville oranges, pomelos, fruit juices) from 
7 days prior to Day 1 and until collection of the final PK blood sample.
•
When a meal or snack is scheduled at the same time as an ECG and/or vital sign 
assessments, the meal will be provided after the ECG and/or vital sign 
assessments are completed.
5.3.3. Caffeine, Alcohol, and Tobacco
•
Participants will abstain from alcohol for ≥24 hours prior to admission for inpatient 
stay on Day -1 (and for red wine, abstain for at least 7 days prior to Day 1), and 
continue abstaining from alcohol until collection of the final PK blood sample.
•
Participants will undergo breath alcohol tests at timepoints indicated in the SoA, 
and at the discretion of the investigator.
•
Consumption of caffeinated drinks and tobacco (or nicotine containing products) is 
permitted during participation in the study; however, there may be a need for brief 
interruption while at the site, depending on local site policy. In addition:
•
Participants must abstain from caffeine-containing products for a minimum of 
2 hours prior to all vital signs and ECG measurements conducted throughout 
study participation (from Screening S1 to the final Follow-up contact).
•
Smoking may not be permitted when it would interfere with the timing of 
scheduled study procedures. In addition, participants must abstain from use of 
tobacco- or nicotine-containing products: for a minimum of 2 hours prior to all 
vital sign and ECG measurements; for a minimum of 2 hours prior to and 
following administration of study intervention.
5.3.4. Activity
•
Participants will not be permitted to engage in physically strenuous exercise (for 
example: heavy lifting, weight training, calisthenics, and aerobics) within 48 hours 
before each blood sample collection for clinical laboratory tests while participating in
the study; physical activity at an individual participant’s normal pace is permitted.
•
In order to standardize the conditions on PK sampling days, all participants will be 
required to refrain from lying down (except when required for study procedures 
eg, ECG measurements), eating, and drinking beverages other than water during the 
first 4 hours after dosing.
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5.4. Screen Failures
Screen failures are defined as participants who consent to participate in the clinical study but 
are not subsequently enrolled in the study. Screen failure data are collected and remain as 
source and are not reported on the CRF.
In this study, participants may be rescreened only after contact with a sponsor Clinical 
representative. This may be permitted when, for example, a participant who qualified for this 
study but did not enroll within the protocol prescribed screening period of 28 days due to 
logistical constraints or administrative reasons. In addition, for participants in Groups 2-4 
only, rescreening may be appropriate following mild intercurrent illness after the condition 
has resolved. Otherwise, individuals who do not meet the criteria for participation in this 
study (screen failure) may not be re-screened.
In case of re-screening, all screening procedures must be repeated and the participant 
assigned a new 8-digit SSID number. Participants must be deemed to meet all the eligibility 
criteria under the new 8-digit SSID before progressing to Day 1. Reconsent is required.
6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY
Study interventions are all prespecified investigational and medical devices, and other 
interventions (eg, surgical and behavioral) intended to be administered to the study 
participants during the study conduct. For the purposes of this protocol, study intervention 
refers to PF-07081532.
6.1. Study Intervention(s) Administered
Study Intervention(s)
Intervention Name
PF-07081532
Arm Name
(group of participants receiving a 
specific treatment or no treatment)
Group 1, Group 2, Group 3, Group 4
Type
Drug
Dose Formulation
Tablet
Unit Dose Strength(s)
20 mg 
Dosage Level(s)
20 mg, single dose 
Route of Administration
Oral
Use
Experimental
IMP or NIMP/AxMP
IMP 
Sourcing
Provided centrally by the sponsor. Refer to the IPM.
Packaging and Labeling
Study intervention will be provided as open-label supply in bulk bottles
along with individual dose containers, as necessary, for unit dosing.
Current/Former Name(s) or Alias(es)
PF-07081532 20 mg tablets
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Study Arm(s)
Arm Title
Group 1
Group 2
Group 3
Group 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm 
Description
Participants 
without renal
impairment will 
receive a single 
20 mg dose of 
PF-07081532, 
administered orally 
Participants with 
mild renal
impairment will 
receive a single 
20 mg dose of 
PF-07081532, 
administered orally 
Participants with 
moderate renal
impairment will 
receive a single 
20 mg dose of 
PF-07081532, 
administered orally
Participants with 
severe renal
impairment will 
receive a single 
20 mg dose of 
PF-07081532, 
administered orally 
Associated 
Intervention 
Labels
PF-07081532
PF-07081532
PF-07081532
PF-07081532
PF-07081532 will be supplied by Pfizer as 20 mg tablets in open-label bulk bottles along 
with individual dosing containers, as necessary, for unit dosing. Participants will take 1 tablet 
orally, with the morning meal as described in Section 5.3.2.
6.1.1. Administration
Following an overnight fast of at least 8 hours, participants will receive breakfast as outlined 
in Section 5.3.2 (Meals and Dietary Restrictions). The participants will then receive study 
intervention at approximately 08:00 hours (plus or minus 2 hours) on Day 1. Investigator site 
personnel will administer study intervention with ambient temperature water to a total 
volume of approximately 240 mL. Participants will swallow the study intervention whole, 
and will not manipulate or chew the study intervention prior to swallowing. 
6.2. Preparation, Handling, Storage, and Accountability
1. The investigator or designee must confirm that appropriate conditions 
(eg, temperature) have been maintained during transit for all study interventions
received and any discrepancies are reported and resolved before use of the study 
intervention. 
2. Only participants enrolled in the study may receive study intervention and only 
authorized site staff may supply, prepare, and/or administer study intervention.
3. All study interventions must be stored in a secure, environmentally controlled, and 
monitored (manual or automated recording) area in accordance with the labeled 
storage conditions with access limited to the investigator and authorized site staff. At 
a minimum, daily minimum and maximum temperatures for all site storage locations 
must be documented and available upon request. Data for nonworking days must 
indicate the minimum and maximum temperatures since previously documented upon 
return to business.
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4. Any excursions from the study intervention label storage conditions should be 
reported toPfizer upon discovery along with actions taken. The site should actively 
pursue options for returning the study intervention to the labeled storage conditions, 
as soon as possible. Once an excursion is identified, the study intervention must be 
quarantined and not used until Pfizer provides permission to use the study 
intervention. Specific details regarding the excursion definition and information to
report for each excursion will be provided to the site in the IPM.
5. Any storage conditions stated in the SRSD will be superseded by the storage 
conditions stated on the label.
6. Study interventions should be stored in their original containers.
7. The investigator, institution, head of the medical institution (where applicable), or 
authorized site staff is responsible for study intervention accountability, 
reconciliation, and record maintenance (ie, receipt, reconciliation, and final 
disposition records), such as the IPAL or sponsor-approved equivalent. All study 
interventions will be accounted for using a study intervention accountability 
form/record.
8. Further guidance and information for the final disposition of unused study 
interventions are provided in the IPM. All destruction must be adequately 
documented. If destruction is authorized to take place at the investigator site, the 
investigator must ensure that the materials are destroyed in compliance with 
applicable environmental regulations, institutional policy, and any special instructions 
provided by Pfizer.
Upon identification of a product complaint, notify the sponsor within 1 business day of 
discovery as described in the IPM.
6.2.1. Preparation and Dispensing
Within this protocol, preparation refers to the investigator site activities performed to make 
the study intervention ready for administration or dispensing to the participant by qualified 
staff. Dispensing is defined as the provision of study intervention, concomitant treatments, 
and accompanying information by qualified staff member(s) to a healthcare provider, 
participant, in accordance with this protocol. Local health authority regulations or 
investigator site guidelines may use alternative terms for these activities.
Tablets will be prepared at the CRU in the individual dosing containers by 2 operators, 1 of 
whom is an appropriately qualified and experienced member of the study staff (eg, physician, 
nurse, physician’s assistant, nurse practitioner, pharmacy assistant/technician, or pharmacist). 
The tablets will be provided in unit dose containers and labeled in accordance with Pfizer 
regulations and the clinical site’s labeling requirements. 
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6.3. Assignment to Study Intervention
This is an open-label study. Following completion of informed consent at Screening visit S1, 
each participant will be assigned a single 8-digit SSID number by the site staff. The first 
4 digits of the SSID will reflect the sponsor-assigned site number and the remaining 4 digits 
will reflect each participant’s unique number assigned in chronological order of when 
informed consent is obtained. Each participant who is dosed with the study intervention will 
be assigned a separate, distinct number (as provided to the site by the Sponsor) to enable 
execution of Sponsors’standard processes for analysis of PK samples. 
6.4. Blinding
This is an open-label study. 
6.4.1. Blinding of Participants
Participants will be unblinded to their assigned study intervention.
6.4.2. Blinding of Site Personnel
Investigators and other site staff will be unblinded to participants’ assigned study 
intervention. 
6.4.3. Blinding of the Sponsor
Sponsor staff will be unblinded to participants’ assigned study intervention. 
6.5. Study Intervention Compliance
When the individual dose for a participant is prepared from a bulk supply, the preparation of 
the dose will be confirmed by a second qualified member of the study site staff.
When participants are dosed at the site, they will receive study intervention directly from the 
investigator or designee, under medical supervision. The date and time of each dose 
administered in the clinic will be recorded in the source documents and recorded in the CRF. 
The dose of study intervention and study participant identification will be confirmed at the 
time of dosing by a member of the study site staff other than the person administering the 
study intervention. Study site personnel will examine each participant’s mouth to ensure that 
the study intervention was ingested.
A record of the number of study intervention tablets dispensed to and taken by each 
participant must be maintained and reconciled with study intervention and compliance 
records.
6.6. Dose Modification
Dose modification of PF-07081532 is not allowed.
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6.7. Continued Access to Study Intervention After the End of the Study
No study intervention will be provided to participants after the end of their study 
participation. It is expected that participants will be treated as required with standard-of-care 
treatments, as advised by their usual care physician.
6.8. Treatment of Overdose
For this study, any dose of PF-07081532 greater than
g within a 24-hour time period will 
be considered an overdose. This dose is projected to result in exposure that will exceed that 
observed at the NOAEL in the pivotal 9-month toxicology study in monkeys, after 
accounting for species differences in plasma protein binding.
There is no specific treatment for an overdose.
In the event of an overdose, the investigator/treating physician should:
1. Contact the study medical monitor within 24 hours.
2. Closely monitor the participant for any AEs/SAEs and laboratory abnormalities as 
medically appropriate at least until the next scheduled follow-up.
3. Document the quantity of the excess dose as well as the duration of the overdose in 
the CRF.
4. Overdose is reportable to Pfizer Safety only when associated with an SAE.
5. Obtain a blood sample for PK analysis within 3 days from the date of the last dose of 
study intervention if requested by the study medical monitor (determined on a 
case-by-case basis).
6.9. Prior and Concomitant Therapy
All concomitant treatments (both prescription and over-the-counter) taken during the study 
must be recorded with indication, daily dose, and start and stop dates of administration. All 
participants will be questioned about concomitant treatment at each clinic visit.
Treatments taken within 28 days before study intervention dosing on Day 1 will be 
documented as a prior treatment. Treatments taken after the first dose of study intervention 
will be documented as concomitant treatments.
Participants on certain medications are excluded from the study (see Appendix 9 for list of 
prohibited medications due to potential DDI and Appendix 10 for a list of other prohibited 
medications). Sites are encouraged to contact the sponsor should there be questions as to 
whether a medication is permitted or prohibited.
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Females using hormonal contraceptives or taking hormone replacement therapy are eligible 
to participate in this study. See Appendix 4 for hormonal contraceptives that are permitted in 
this study. 
Participants with T2DM and either normal renal function or renal impairment are permitted 
to be on stable doses of background medications for the management of their concomitant 
medical condition(s), as long as this is in line with protocol specifications regarding 
prohibited medications as described in this Section and in Appendix 9 and Appendix 10. On 
a case-by-case basis, with approval from the sponsor, participants receiving fluctuating 
concomitant medication/treatment may be considered if the underlying disease is under 
control. Whenever possible, attempts must be made to not add new medications or alter the 
doses and regimens of the concomitant medications after enrollment and for the duration of 
participation in this study, except in circumstances where a change is deemed medically 
necessary. Any changes must be captured in the CRF.
In addition, participants with T2DM using insulin are permitted to have sliding scale insulin 
or dose adjustment in insulin while confined to the CRU to attempt to maintain fasting and 
post-prandial glucose readings at similar levels that are achieved at home and based on the 
calories consumed while confined in the CRU.
Participants may receive permitted background medications according to their stable 
medication routine at their usual dosing times. This is with the exception of phosphate 
binders, antacids, and bile acid binding resins (eg, cholestyramine, colestipol), which must 
not be administered within the 8 hours before study intervention dosing on Day 1 or within 
the 4 hours after study intervention dosing. On Day 1, the investigator will determine the 
appropriate time to administer medications that are to be taken on an empty stomach. 
Otherwise, permitted concomitant medications that may be administered under fed 
conditions can be taken with breakfast on the morning of Day 1. On all other study days, 
participants are to receive their background medications at their usual times.
6.9.1. Rescue Medicine
There is no rescue therapy to reverse AEs observed with PF-07081532; standard medical 
supportive care must be provided to manage any AEs.
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL
7.1. Discontinuation of Study Intervention
Since this is a single-dose study, this section is N/A.
7.2. Participant Discontinuation/Withdrawal From the Study
A participant may withdraw from the study at any time at their own request. Reasons for 
discontinuation from the study include the following: safety, behavioral, compliance or 
administrative reasons, or if the study is terminated by sponsor.
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At the time of discontinuing from the study, if possible, an early discontinuation visit should 
be conducted. See the SoA for assessments to be collected at the time of study 
discontinuation and follow-up and for any further evaluations that need to be completed. 
The early discontinuation visit applies only to participants who are enrolled/randomized and 
then are prematurely withdrawn from the study. Participants should be questioned regarding 
their reason for withdrawal.
The participant will be permanently discontinued from the study intervention and the study at 
that time.
If a participant withdraws from the study, they may request destruction of any remaining 
samples taken and not tested, and the investigator must document any such requests in the 
site study records and notify the sponsor accordingly.
If the participant withdraws from the study and also withdraws consent (see Section 7.2.1) 
for disclosure of future information, no further evaluations will be performed and no 
additional data will be collected. The sponsor may retain and continue to use any data 
collected before such withdrawal of consent.
7.2.1. Withdrawal of Consent 
Participants who request to discontinue receipt of study intervention will remain in the study 
and must continue to be followed for protocol-specified follow-up procedures. The only 
exception to this is when a participant specifically withdraws consent for any further contact 
with them or persons previously authorized by the participant to provide this information. 
Participants should notify the investigator in writing of the decision to withdraw consent 
from future follow-up, whenever possible. The withdrawal of consent should be explained in 
detail in the medical records by the investigator, as to whether the withdrawal is only from 
further receipt of study intervention or also from study procedures and/or posttreatment study 
follow-up, and entered on the appropriate CRF page. In the event that vital status (whether 
the participant is alive or dead) is being measured, publicly available information should be 
used to determine vital status only as appropriately directed in accordance with local law.
7.3. Lost to Follow-up 
A participant will be considered lost to follow-up if the participant repeatedly fails to return 
for scheduled visits and is unable to be contacted by the study site.
The following actions must be taken if a participant fails to attend a required study visit:
•
The site must attempt to contact the participant and reschedule the missed visit as 
soon as possible. Counsel the participant on the importance of maintaining the 
assigned visit schedule and ascertain whether the participant wishes to and/or should 
continue in the study;
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•
Before a participant is deemed lost to follow-up, the investigator or designee must 
make every effort to regain contact with the participant (where possible, 3 telephone 
calls and, if necessary, a certified letter to the participant’s last known mailing 
address or local equivalent methods). These contact attempts should be documented 
in the participant’s medical record;
•
Should the participant continue to be unreachable, the participant will be considered 
to have withdrawn from the study. 
8. STUDY ASSESSMENTS AND PROCEDURES
8.1. Administrative Procedures
The investigator (or an appropriate delegate at the investigator site) must obtain a signed and 
dated ICD before performing any study-specific procedures. 
Study procedures and their timing are summarized in the SoA. Protocol waivers or 
exemptions are not allowed.
Adherence to the study design requirements, including those specified in the SoA, is essential 
and required for study conduct.
All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. The investigator will maintain a screening log to 
record details of all participants screened and to confirm eligibility or record reasons for 
screening failure, as applicable.
Participants will be screened within 28 days prior to administration of the study intervention 
to confirm that they meet the study population criteria for the study. If the time between 
screening and dosing exceeds 28 days as a result of unexpected delays (eg, delayed drug 
shipment), then participants may be rescreened after contact with a sponsor Clinical 
representative as described in Section 5.4.
Every effort should be made to ensure that protocol-required tests and procedures are 
completed as described. However, it is anticipated that from time to time there may be 
circumstances outside the control of the investigator that make it unfeasible to perform the 
test. In these cases, the investigator must take all steps necessary to ensure the safety and 
well-being of the participant. When a protocol-required test cannot be performed, the 
investigator will document the reason for the missed test and any corrective and preventive 
actions that they have taken to ensure that required processes are adhered to as soon as 
possible. The study team must be informed of these incidents in a timely manner.
If done around the time of a blood draw, ECGs and vital sign assessments (pulse rate, BP, 
and temperature) should be collected prior to any blood draw. If an IV catheter is utilized for 
blood sample collections, ECGs and vital sign assessments (pulse rate and BP) should be 
collected prior to the insertion of the catheter.
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For samples being collected and shipped, detailed collection, processing, storage, and 
shipment instructions and contact information will be provided to the investigator site prior 
to initiation of the study.
The total blood sampling volume for individual participants in this study is approximately 
150 mL. The actual collection times of blood sampling may change. Additional blood 
samples may be taken for safety assessments at times specified by Pfizer, provided the total 
volume taken during the study does not exceed 550 mL during any period of 56 consecutive 
days.
To prepare for study participation, participants will be instructed on the information in the 
Lifestyle Considerations and Concomitant Therapy sections of the protocol.
8.2. Efficacy Assessments
Not applicable. 
8.3. Safety Assessments
Planned time points for all safety assessments are provided in the SoA. Unscheduled safety
measurements may be obtained at any time during the study to assess any perceived safety 
issues.
8.3.1. Physical Examinations
A complete physical examination will include, at a minimum, head, ears, eyes, nose, mouth,
neck, skin, heart and lung examinations, lymph nodes, and GI, musculoskeletal, and 
neurological systems. 
A limited physical examination will include, at a minimum, assessments of general 
appearance, the respiratory and cardiovascular systems, and participant-reported symptoms.
Physical examinations may be conducted by a physician, trained physician’s assistant, or 
nurse practitioner as acceptable according to local regulations. 
Height and weight will also be measured as per the SoA and recorded in the CRF. For 
measuring weight, a scale with appropriate range and resolution is used and must be placed 
on a stable, flat surface. Participants must remove shoes, bulky layers of clothing, and jackets 
so that only light clothing remains. They must also remove the contents of their pockets and 
remain still during measurement of weight. 
Physical examination findings collected during the study will be considered source data and 
will not be required to be reported, unless otherwise noted. Any untoward physical 
examination findings that are identified during the active collection period and meet the 
definition of an AE or SAE (Appendix 3) must be reported according to the processes in 
Sections 8.4.1 to 8.4.3.
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8.3.2. Vital Signs
8.3.2.1. Blood Pressure and Pulse Rate
BP and pulse rate will be measured as defined in the SoA. 
•
Single, seated BP and pulse rate will be measured with the participant’s arm 
supported at the level of the heart, and recorded to the nearest mmHg, following a 
seated rest of ≥5 minutes;
•
Same arm (preferably the dominant arm) will be used for BP/pulse rate assessment 
throughout the study;
•
BP/pulse rate assessment should not be taken from the arm with an IV catheter, if 
placed;
•
Participants should be instructed not to speak during BP/pulse rate measurements.
The same properly sized and calibrated BP cuff will be used to measure BP each time. The 
use of an automated device for measuring BP and pulse rate is acceptable; however, when 
done manually, pulse rate will be measured in the brachial/radial artery for at least 
30 seconds. When the timing of these measurements coincides with a blood collection, BP 
and pulse rate should be obtained prior to the nominal time of the blood collection. 
Additional collection times, or changes to collection times, of BP and pulse rate will be 
permitted, as necessary, to ensure appropriate collection of safety data.
Any untoward vital sign findings that are identified during the active collection period and 
meet the definition of an AE or SAE (Appendix 3) must be reported according to the 
processes in Sections 8.4.1 to 8.4.3.
8.3.3. Electrocardiograms
Supine standard 12-lead ECGs utilizing limb leads (with a 10-second rhythm strip) should be 
collected at times specified in the SoA section of this protocol using an ECG machine that 
automatically calculates the HR and measures PR interval, QT interval, QTcF, and QRS 
complex. Alternative lead placement methodology using torso leads (eg, Mason-Likar) 
should not be used given the potential risk of discrepancies with ECGs acquired using 
standard limb lead placement. All scheduled ECGs should be performed after the participant
has rested quietly for at least 5 minutes in a supine position. 
To ensure safety of the participants, a qualified individual at the investigator site will make 
comparisons to baseline measurements. Additional ECG monitoring will occur if a) a 
postdose QTcF interval is increased by ≥60 ms from the baseline and is >450 ms; or b) an 
absolute QT value is ≥500 ms for any scheduled ECG. If either of these conditions occurs, 
then 2 additional ECGs will be collected 2-4 minutes apart to confirm the original 
measurement. If the QTcF values from these repeated ECGs remain above the threshold 
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value, then a single ECG must be repeated at least hourly until QTc values from 2 successive 
ECGs fall below the threshold value that triggered the repeat measurement.
If a) a postdose QTcF interval remains ≥60 ms from the baseline and is >450 ms; or b) an 
absolute QT value is ≥500 ms for any scheduled ECG for greater than 4 hours (or sooner, at 
the discretion of the investigator); or c) QTcF value get progressively longer, the participant
should undergo continuous ECG monitoring. A cardiologist should be consulted if QTcF
values do not return to less than the criteria listed above after 8 hours of monitoring (or 
sooner, at the discretion of the investigator).
In some cases, it may be appropriate to repeat abnormal ECGs to rule out improper lead 
placement as contributing to the ECG abnormality. It is important that leads be placed in the 
same positions each time in order to achieve precise ECG recordings. If a machine-read QTc 
value is prolonged, as defined above, repeat measurements may not be necessary if a 
qualified medical provider’s interpretation determines that the QTcF values are in the 
acceptable range.
ECG values of potential clinical concern are listed in Appendix 8.
8.3.4. Clinical Safety Laboratory Assessments
See Appendix 2 for the list of clinical safety laboratory tests to be performed and the SoA for 
the timing and frequency. All protocol-required laboratory assessments, as defined in 
Appendix 2, must be conducted in accordance with the laboratory manual and the SoA. 
Unscheduled clinical laboratory measurements may be obtained at any time during the study 
to assess any perceived safety issues.
The investigator must review the laboratory report, document this review, and record any 
clinically significant changes occurring during the study in the AE section of the CRF. 
Clinically significant abnormal laboratory test findings are those that are not associated with 
the underlying disease, unless judged by the investigator to be more severe than expected for 
the participant’s condition.
All laboratory tests with values considered clinically significant and abnormal during 
participation in the study or within 5 days after the last dose of study intervention should be 
repeated until the values return to normal or baseline or are no longer considered clinically 
significant by the investigator or study medical monitor.
If such values do not return to normal/baseline within a period of time judged reasonable by 
the investigator, the etiology should be identified and the sponsor notified.
See Appendix 6 for suggested actions and follow-up assessments in the event of potential 
DILI.
See Appendix 7 for instructions for laboratory testing to monitor kidney function and 
reporting laboratory test abnormalities.
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Participants may undergo random urine drug testing at the discretion of the investigator.
Drug testing conducted prior to dosing must be negative for participants to receive study 
intervention. 
8.3.4.1. Fasting Fingerstick Blood Glucose (via Glucometer)
Investigators will monitor fasting FSBG using a glucometer. While the participant is 
confined to the CRU, FSBG measurements should be taken each morning before breakfast.
FSBG readings will be maintained at the CRU in source documents, and only the glucose 
results from the laboratory will be reported in the study database. The sites may share the 
FSBG readings with the sponsor, if necessary for the purpose of safety monitoring, but these 
data will be stored in the CRU source documents unless related to an AE as described in 
Section 8.3.4.2. 
If an FSBG result is <70 mg/dL
•
A second FSBG should be obtained to confirm the glucose value – this is in addition 
to a venous sample that will be sent to the clinical laboratory for confirmation. 
•
If the value from this second FSBG is also <70 mg/dL, the second value will be 
recorded as an HAE (see Section 8.3.4.2) and must be captured on the AE CRF, with 
specific details captured on the HAE CRF. 
•
FSBG will continue to be monitored until the glucose value returns to ≥70 mg/dL. 
Samples may be taken more frequently if deemed necessary by the investigator.
FSBG readings from a glucometer are permitted at any time if the investigator or participant 
notes symptoms of hypoglycemia. Any episode of hypoglycemia must be captured on the AE 
CRF with specific details captured on the HAE Form CRF.
8.3.4.2. Definition and Severity of Hypoglycemic Adverse Event
The investigator must assess any glucose values, if measured, as well as any signs or 
symptoms reported by the study participant.
HAE is defined as one of the following:13
•
Asymptomatic hypoglycemia: An event not accompanied by typical symptoms of 
HAE but a glucose value of <70 mg/dL (3.9 mmol/L) using either glucometer 
(fingerstick blood glucose) at the study site or sponsor approved laboratory (plasma 
glucose).
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•
Documented symptomatic hypoglycemia: An event during which typical symptoms 
of HAE are accompanied with a glucose value of <70 mg/dL (3.9 mmol/L), using 
glucometer (fingerstick blood glucose) at the study site or sponsor approved 
laboratory (plasma glucose), and the clinical picture includes prompt resolution with 
food intake, subcutaneous glucagon, or IV glucose.
•
Probable symptomatic hypoglycemia: An event during which symptoms of HAE are 
not accompanied by a glucose determination but was presumably caused by a glucose 
concentration of <70 mg/dL (3.9 mmol/L), and the clinical picture includes prompt 
resolution with food intake, subcutaneous glucagon, or IV glucose.
Each episode of HAE must be categorized with respect to severity. In order to characterize 
the event as severe, all 3 criteria below must be met:
1. The participant was unable to treat him/herself. Neurologic impairment, and not the 
age of the participant, is the explanation for why the participant could not treat 
him/herself and required the assistance of another person.
2. The participant exhibited at least 1 of the following neurological symptoms:
•
Memory loss;
•
Confusion;
•
Uncontrolled behavior;
•
Irrational behavior;
•
Unusual difficulty in awakening;
•
Suspected seizure;
•
Seizure;
•
Loss of consciousness.
3. Either:
•
If blood glucose was measured and was ≤54 mg/dL (2.7 mmol/L) using 
glucometer (or laboratory); or
•
If blood glucose was not measured, the clinical manifestations were reversed by 
oral carbohydrates, subcutaneous glucagon, or IV glucose.
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Events that do not meet all the criteria above for severe HAE are characterized as mild or 
moderate in severity.
8.3.5. COVID-19 Specific Assessments 
Assessment of risk for, symptoms of, or testing for COVID-19 may be performed at 
Screening, admission to the CRU, and/or at other times during the study at investigator 
discretion and according to local site policies.
8.3.6. Pregnancy Testing
A serum pregnancy test is required at screening. Following screening, pregnancy tests may 
be urine or serum tests, and must have a sensitivity of at least 25 mIU/mL. Pregnancy tests 
will be performed in WOCBP at the times listed in the SoA. Following a negative pregnancy 
test result at screening, appropriate contraception must be commenced and a second negative 
pregnancy test result will be required at the baseline visit prior to the participant’s receiving 
the study intervention. Pregnancy tests will also be done whenever 1 menstrual cycle is 
missed during the active treatment period (or when potential pregnancy is otherwise 
suspected) and at the end of the study. Pregnancy tests may also be repeated if requested by 
IRBs/ECs or if required by local regulations. If a urine test cannot be confirmed as negative 
(eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant 
must be excluded if the serum pregnancy result is positive.
8.4. Adverse Events, Serious Adverse Events, and Other Safety Reporting
The definitions of an AE and an SAE can be found in Appendix 3.
AEs may arise from symptoms or other complaints reported to the investigator by the 
participant (or, when appropriate, by a caregiver, surrogate, or the participant’s legally 
authorized representative), or they may arise from clinical findings of the investigator or 
other healthcare providers (clinical signs, test results, etc).
The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE or SAE and remain responsible to pursue 
and obtain adequate information both to determine the outcome and to assess whether the 
event meets the criteria for classification as an SAE or caused the participant to discontinue 
the study (see Section 7.1). 
During the active collection period as described in Section 8.4.1, each participant will be 
questioned about the occurrence of AEs in a nonleading manner.
In addition, the investigator may be requested by Pfizer Safety to obtain specific follow-up 
information in an expedited fashion.
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8.4.1. Time Period and Frequency for Collecting AE and SAE Information
The time period for actively eliciting and collecting AEs and SAEs (“active collection 
period”) for each participant begins from the time the participant provides informed consent, 
which is obtained before undergoing any study-related procedure and/or receiving study 
intervention), through and including a minimum of 28 calendar days, except as indicated 
below, after the last administration of the study intervention.
Follow-up by the investigator continues throughout the active collection period and until the 
AE or SAE or its sequelae resolve or stabilize at a level acceptable to the investigator.
When a clinically important AE remains ongoing at the end of the active collection period, 
follow-up by the investigator continues until the AE or SAE or its sequelae resolve or 
stabilize at a level acceptable to the investigator and Pfizer concurs with that assessment.
For participants who are screen failures, the active collection period ends when screen failure 
status is determined.
If the participant withdraws from the study and also withdraws consent for the collection of 
future information, the active collection period ends when consent is withdrawn.
If a participant permanently discontinues or temporarily discontinues study because of an AE 
or SAE, the AE or SAE must be recorded on the CRF and the SAE reported using the CT 
SAE Report Form.
Investigators are not obligated to actively seek information on AEs or SAEs after the 
participant has concluded study participation. However, if the investigator learns of any SAE, 
including a death, at any time after a participant has completed the study, and they consider 
the event to be reasonably related to the study intervention, the investigator must promptly 
report the SAE to Pfizer using the CT SAE Report Form.
8.4.1.1. Reporting SAEs to Pfizer Safety
All SAEs occurring in a participant during the active collection period as described in 
Section 8.4.1 are reported to Pfizer Safety on the CT SAE Report Form immediately upon 
awareness and under no circumstance should this exceed 24 hours, as indicated in 
Appendix 3. The investigator will submit any updated SAE data to the sponsor within 
24 hours of its being available.
8.4.1.2. Recording Nonserious AEs and SAEs on the CRF
All nonserious AEs and SAEs occurring in a participant during the active collection period, 
which begins after obtaining informed consent as described in Section 8.4.1, will be recorded 
on the AE section of the CRF.
The investigator is to record on the CRF all directly observed and all spontaneously reported 
AEs and SAEs reported by the participant.
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As part of ongoing safety reviews conducted by the sponsor, any nonserious AE that is 
determined by the sponsor to be serious will be reported by the sponsor as an SAE. To assist 
in the determination of case seriousness, further information may be requested from the 
investigator to provide clarity and understanding of the event in the context of the clinical 
study.
Reporting of AEs and SAEs for participants who fail screening are subject to the CRF 
requirements as described in Section 5.4.
8.4.2. Method of Detecting AEs and SAEs
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Appendix 3.
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
nonleading verbal questioning of the participant is the preferred method to inquire about 
AE occurrences.
8.4.3. Follow-Up of AEs and SAEs
After the initial AE or SAE report, the investigator is required to proactively follow each 
participant at subsequent visits/contacts. For each event, the investigator must pursue and 
obtain adequate information until resolution, stabilization, the event is otherwise explained, 
or the participant is lost to follow-up (as defined in Section 7.3).
In general, follow-up information will include a description of the event in sufficient detail to 
allow for a complete medical assessment of the case and independent determination of 
possible causality. Any information relevant to the event, such as concomitant medications 
and illnesses, must be provided. In the case of a participant death, a summary of available 
autopsy findings must be submitted as soon as possible to Pfizer Safety. 
Further information on follow-up procedures is provided in Appendix 3.
8.4.4. Regulatory Reporting Requirements for SAEs
Prompt notification by the investigator to the sponsor of an SAE is essential so that legal 
obligations and ethical responsibilities toward the safety of participants and the safety of a 
study intervention under clinical investigation are met.
The sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study intervention under clinical investigation. The 
sponsor will comply with country-specific regulatory requirements relating to safety 
reporting to the regulatory authority, IRBs/ECs, and investigators.
Investigator safety reports must be prepared for SUSARs according to local regulatory 
requirements and sponsor policy and forwarded to investigators as necessary.
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An investigator who receives SUSARs or other specific safety information (eg, summary or 
listing of SAEs) from the sponsor will review and then file it along with the SRSD(s) for the 
study and will notify the IRB/EC, if appropriate according to local requirements.
8.4.5. Environmental Exposure, Exposure During Pregnancy or Breastfeeding, and 
Occupational Exposure
Environmental exposure, occurs when a person not enrolled in the study as a participant 
receives unplanned direct contact with or exposure to the study intervention. Such exposure 
may or may not lead to the occurrence of an AE or SAE. Persons at risk for environmental 
exposure include healthcare providers, family members, and others who may be exposed. An 
environmental exposure may include EDP, EDB, and occupational exposure.
Any such exposures to the study intervention under study are reportable to Pfizer Safety 
within 24 hours of investigator awareness.
8.4.5.1. Exposure During Pregnancy
An EDP occurs if: 
•
A female participant is found to be pregnant while receiving or after discontinuing 
study intervention.
•
A male participant who is receiving or has discontinued study intervention
inseminates a female partner. 
•
A female nonparticipant is found to be pregnant while being exposed or having been 
exposed to study intervention because of environmental exposure. Below are 
examples of environmental EDP: 
•
A female family member or healthcare provider reports that she is pregnant after 
having been exposed to the study intervention by ingestion.
The investigator must report EDP to Pfizer Safety within 24 hours of the investigator’s 
awareness, irrespective of whether an SAE has occurred. The initial information submitted 
should include the anticipated date of delivery (see below for information related to 
termination of pregnancy). 
•
If EDP occurs in a participant/participant’s partner, the investigator must report this 
information to Pfizer Safety on the CT SAE Report Form and an EDP Supplemental 
Form, regardless of whether an SAE has occurred. Details of the pregnancy will be 
collected after the start of study intervention and until 28 days after the last dose.
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•
If EDP occurs in the setting of environmental exposure, the investigator must report 
information to Pfizer Safety using the CT SAE Report Form and EDP Supplemental 
Form. Since the exposure information does not pertain to the participant enrolled in 
the study, the information is not recorded on a CRF; however, a copy of the 
completed CT SAE Report Form is maintained in the investigator site file.
Follow-up is conducted to obtain general information on the pregnancy and its outcome for 
all EDP reports with an unknown outcome. The investigator will follow the pregnancy until 
completion (or until pregnancy termination) and notify Pfizer Safety of the outcome as a 
follow-up to the initial EDP Supplemental Form. In the case of a live birth, the structural 
integrity of the neonate can be assessed at the time of birth. In the event of a termination, the 
reason(s) for termination should be specified and, if clinically possible, the structural 
integrity of the terminated fetus should be assessed by gross visual inspection (unless 
preprocedure test findings are conclusive for a congenital anomaly and the findings are 
reported).
Abnormal pregnancy outcomes are considered SAEs. If the outcome of the pregnancy meets 
the criteria for an SAE (ie, ectopic pregnancy, spontaneous abortion, intrauterine fetal 
demise, neonatal death, or congenital anomaly in a live-born baby, a terminated fetus, an 
intrauterine fetal demise, or a neonatal death), the investigator should follow the procedures 
for reporting SAEs. 
Additional information about pregnancy outcomes that are reported to Pfizer Safety as SAEs 
follows: 
•
Spontaneous abortion including miscarriage and missed abortion should be reported 
as an SAE;
•
Neonatal deaths that occur within 1 month of birth should be reported, without regard 
to causality, as SAEs. In addition, infant deaths after 1 month should be reported as 
SAEs when the investigator assesses the infant death as related or possibly related to 
exposure to the study intervention. 
Additional information regarding the EDP may be requested by the sponsor. Further 
follow-up of birth outcomes will be handled on a case-by-case basis (eg, follow-up on 
preterm infants to identify developmental delays). In the case of paternal exposure, the 
investigator will provide the participant with the Pregnant Partner Release of Information 
Form to deliver to his partner. The investigator must document in the source documents that 
the participant was given the Pregnant Partner Release of Information Form to provide to his 
partner.
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8.4.5.2. Exposure During Breastfeeding
An EDB occurs if: 
•
A female participant is found to be breastfeeding while receiving or after 
discontinuing study intervention.
•
A female nonparticipant is found to be breastfeeding while being exposed or having 
been exposed to study intervention (ie, environmental exposure). An example of 
environmental EDB is a female family member or healthcare provider who reports 
that she is breastfeeding after having been exposed to the study intervention by 
ingestion. 
The investigator must report EDB to Pfizer Safety within 24 hours of the investigator’s 
awareness, irrespective of whether an SAE has occurred. The information must be reported 
using the CT SAE Report Form. When EDB occurs in the setting of environmental exposure, 
the exposure information does not pertain to the participant enrolled in the study, so the 
information is not recorded on a CRF. However, a copy of the completed CT SAE Report 
Form is maintained in the investigator site file.
An EDB report is not created when a Pfizer drug specifically approved for use in 
breastfeeding women (eg, vitamins) is administered in accordance with authorized use. 
However, if the infant experiences an SAE associated with such a drug, the SAE is reported 
together with the EDB.
8.4.5.3. Occupational Exposure
The investigator must report any instance of occupational exposure to Pfizer Safety within 
24 hours of the investigator’s awareness using the CT SAE Report Form regardless of 
whether there is an associated SAE. Since the information about the occupational exposure 
does not pertain to a participant enrolled in the study, the information is not recorded on a 
CRF; however, a copy of the completed CT SAE Report Form must be maintained in the 
investigator site file.
8.4.6. Cardiovascular and Death Events
Not applicable.
8.4.7. Disease-Related Events and/or Disease-Related Outcomes Not Qualifying as AEs 
or SAEs
Not applicable.
8.4.8. Adverse Events of Special Interest
Not applicable.
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8.4.8.1. Lack of Efficacy
This section is not applicable because efficacy is not expected in the study population.
8.4.9. Medical Device Deficiencies
Not applicable. 
8.4.10. Medication Errors
Medication errors may result from the administration or consumption of the study 
intervention by the wrong participant, or at the wrong time, or at the wrong dosage strength.
Medication errors are recorded and reported as follows:
Recorded on the 
Medication Error Page 
of the CRF
Recorded on the 
Adverse Event Page 
of the CRF
Reported on the CT SAE 
Report Form to Pfizer 
Safety Within 24 Hours of 
Awareness
All (regardless of whether 
associated with an AE)
Any AE or SAE associated 
with the medication error
Only if associated with an 
SAE
Medication errors include:
•
Medication errors involving participant exposure to the study intervention;
•
Potential medication errors or uses outside of what is foreseen in the protocol that do 
or do not involve the study participant.
Such medication errors occurring to a study participant are to be captured on the medication 
error page of the CRF, which is a specific version of the AE page.
Whether or not the medication error is accompanied by an AE, as determined by the 
investigator, the medication error is recorded on the medication error page of the CRF and, if 
applicable, any associated AE(s), serious and nonserious, are recorded on the AE page of the 
CRF.
In the event of a medication dosing error, the sponsor should be notified within 24 hours.
Medication errors should be reported to Pfizer Safety within 24 hours on a CT SAE Report 
Form only when associated with an SAE.
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8.5. Pharmacokinetics 
8.5.1. Plasma for Analysis of PF-07081532
Blood samples of approximately 3 mL, to provide a minimum volume of 1 mL plasma, will 
be collected into appropriately labeled tubes containing K2EDTA for measurement of plasma 
concentrations of PF-07081532 as specified in the SoA. Instructions for the collection and 
handling of biological samples will be provided in the laboratory manual or by the sponsor. 
The actual date and time (24-hour clock time) of each sample will be recorded.
The actual times may change, but the number of samples will remain the same. All efforts 
will be made to obtain the samples at the exact nominal time relative to dosing. Collection of 
samples up to and including 10 hours after dose administration that are obtained within 
10% of the nominal time relative to dosing (eg, within 6 minutes of a 60-minute sample) will 
not be captured as a protocol deviation, as long as the exact time of the collection is noted on 
the source document and the CRF. Collection of samples more than 10 hours after dose 
administration that are obtained ≤1 hour away from the nominal time relative to dosing will 
not be captured as a protocol deviation, as long as the exact time of the collection is noted on 
the source document and the CRF.
Samples will be used to evaluate the PK of PF-07081532. Samples collected for analyses of 
plasma concentration may also be used to evaluate safety or efficacy aspects related to 
concerns arising during or after the study, for metabolite identification and/or evaluation of 
the bioanalytical method, or for other internal exploratory purposes.
Genetic analyses will not be performed on these plasma samples unless consent for this was 
included in the informed consent. Participant confidentiality will be maintained.
Samples collected for measurement of plasma concentrations of PF-07081532 will be 
analyzed using a validated analytical method in compliance with applicable SOPs. Potential 
metabolites may be analyzed with either validated or exploratory methods.
The PK samples must be processed and shipped as indicated in the instructions provided to 
the investigator site to maintain sample integrity. Any deviations from the PK sample 
handling procedure (eg, sample collection and processing steps, interim storage or shipping 
conditions), including any actions taken, must be documented and reported to the sponsor. 
On a case-by-case basis, the sponsor may make a determination as to whether sample 
integrity has been compromised.
8.5.2. Plasma for Determination of PF-07081532 Unbound Fraction
During the study, blood samples of approximately 10 mL to provide sufficient plasma
(approximately 4 mL) for unbound fraction determination, will be collected into 
appropriately labeled tubes containing K2EDTA, as specified in the SoA. Instructions for the 
collection and handling of biological samples will be provided in the laboratory manual or by 
the sponsor. The actual date and time (24-hour clock time) of each sample will be recorded.
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The actual times may change, but the number of samples will remain the same. All efforts
will be made to obtain the samples at the exact nominal time relative to dosing. Collection of
samples up to and including 10 hours after dose administration that are obtained within
10% of the nominal time relative to dosing (eg, within 6 minutes of a 60-minute sample) will
not be captured as a protocol deviation, as long as the exact time of the collection is noted on
the source document and the CRF. 
Samples collected for analyses of PF-07081532 plasma protein binding may also be used to 
evaluate safety or efficacy aspects related to concerns arising during or after the study, for 
metabolite identification and/or evaluation of the bioanalytical method, or for other internal 
exploratory purposes.
Genetic analyses will not be performed on these plasma samples unless consent for this was
included in the informed consent. Participant confidentiality will be maintained.
Samples collected for measurement of PF-07081532 plasma protein binding will be analyzed 
using a validated analytical method in compliance with applicable SOPs. Potential 
metabolites may be analyzed with either validated or exploratory methods.
The samples for determination of PF-07081532 plasma protein binding must be processed 
and shipped as indicated in the instructions provided to the investigator site to maintain 
sample integrity. Any deviations from the sample handling procedure (eg, sample collection 
and processing steps, interim storage or shipping conditions), including any actions taken, 
must be documented and reported to the sponsor. On a case-by-case basis, the sponsor may 
make a determination as to whether sample integrity has been compromised.
8.5.3. Urine for Analysis of PF-07081532 
Urine will be collected at times specified in the SoA (NOTE that no urine will be collected 
for anuric dialysis participants).
•
Prior to dosing on Day 1, each participant must complete a forced void with an 
aliquot (approximately 10 mL) from this urine (urine blank), labeled and stored 
frozen for measurement of drug concentrations, per detailed instructions offered in a 
laboratory manual prior to the start of the study.
•
Following dosing on Day 1, each void post dose will be collected and saved in a 
container and stored in refrigerated conditions (ie, 2-8°C) for the duration of the 
collection interval, as specified in the SoA.
•
At the end of each collection interval, participants must complete a forced void 
with this complete void included as part of the interval collection. Each collection 
interval should have its own collection container.
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8.7.2. Specified Gene Expression (RNA) Research 
Specified gene expression (RNA) research is not included in this study.
8.7.3. Specified Protein Research 
Specified protein research is not included in this study.
8.7.4. Specified Metabolomic Research 
Specified metabolomic research is not included in this study.
8.8. Immunogenicity Assessments
Immunogenicity assessments are not included in this study.
8.9. Health Economics
Health economics/medical resource utilization and health economics parameters are not 
evaluated in this study.
9. STATISTICAL CONSIDERATIONS
Detailed methodology for summary and statistical analyses of the data collected in this study 
is outlined here and further detailed in the SAP, which will be maintained by the sponsor. 
The SAP may modify what is outlined in the protocol where appropriate; however, any major 
modifications of the primary endpoint definitions or their analyses will also be reflected in a 
protocol amendment.
9.1. Statistical Hypotheses
No formal statistical hypothesis testing will be performed in this study.
9.2. Analysis Sets
For purposes of analysis, the following analysis sets are defined:
Participant Analysis Set
Description
Enrolled 
“Enrolled” means a participant’s, or their legally authorized 
representative’s, agreement to participate in a clinical study 
following completion of the informed consent process and 
assignment to study intervention. A participant will be 
considered enrolled if the informed consent is not withdrawn 
prior to participating in any study activity after screening. 
Potential participants who are screened for the purpose of 
determining eligibility for the study, but do not participate in 
the study, are not considered enrolled, unless otherwise 
specified by the protocol.
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Participant Analysis Set
Description
Safety analysis set
All participants assigned to study intervention and who take 
at least 1 dose of study intervention.
PK Concentration Set
The PK concentration population is defined as all participants 
who received at least 1 dose of PF-07081532 and in whom at 
least 1 plasma concentration value is reported.
PK Parameter Set
The PK parameter analysis population is defined as all 
participants who received at least 1 dose of PF-07081532 and 
have at least 1 of the PK parameters of interest calculated.
9.3. Statistical Analyses
The SAP will be developed and finalized before any analyses are performed and will 
describe the analyses and procedures for accounting for missing, unused, and spurious data. 
This section is a summary of the planned statistical analyses of the primary and secondary 
endpoints.
9.3.1. General Considerations
Endpoints will be reported and analyzed according to the renal impairment group to which 
participants actually belong, based on their average eGFR value (see Table 1).
9.3.1.1. Analyses for PK Endpoints
Natural log-transformed PK parameters will be analyzed using an ANOVA model including 
renal impairment group as fixed effect. Estimates of the adjusted means and of the adjusted 
mean differences (Test-Reference) with their corresponding 90% CIs will be obtained before 
being exponentiated to provide estimates of the adjusted geometric means and of the ratio of 
adjusted geometric means (Test/Reference).
9.3.2. Primary Endpoint(s) Analysis
9.3.2.1. Definition of Endpoint(s)
The plasma PK parameters for PF-07081532 following single dose administration will be 
derived from the concentration-time profiles as detailed in Table 2. Actual PK sampling times 
will be used in the derivation of plasma PK parameters. In the case that actual PK sampling 
times are not available, nominal PK sampling time will be used in the derivation of plasma 
PK parameters. The fraction of PF-07081532 unbound in plasma (fu) will be determined by 
the analytical lab and reported for each participant.
The urine PK parameters listed in Table 3 will be calculated for PF-07081532.
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Table 2.
Plasma PK Parameters
Parameter
Definition
Method of Determination
AUClast
Area under the plasma concentration-
time profile from time zero to the time 
of the last quantifiable concentration 
(Clast).
Linear/Log trapezoidal method.
AUCinf*
Area under the plasma concentration-
time profile from time zero 
extrapolated to infinite time.
AUClast + (Clast*/kel), where Clast* is the 
predicted plasma concentration at the 
last quantifiable time point estimated 
from the log-linear regression analysis.
Cmax
Maximum plasma concentration.
Observed directly from data.
Tmax
Time for Cmax.
Observed directly from data as time of 
first occurrence.
t1/2*
Terminal half-life.
Loge(2)/kel, where kel is the terminal 
phase rate constant calculated by a 
linear regression of the log-linear
Concentration-time curve. Only those 
data points judged to describe the 
terminal log-linear decline will be used 
in the regression.
CL/F*
Apparent clearance.
Dose/AUCinf.
Vz/F*
Apparent volume of distribution.
Dose/(AUCinf ∙kel).
fu
Fraction of unbound drug in plasma.
Cu/C (where Cu represents unbound 
concentration and C represents total 
concentration).
AUClast,u
Unbound AUClast.
fu∙AUClast.
AUCinf,u*
Unbound AUCinf.
fu∙AUCinf.
Cmax,u
Unbound Cmax.
fu∙Cmax.
CLu/F*
Unbound CL/F.
Dose/AUCinf,u.
Vz,u/F*
Unbound Vz/F.
Dose/(AUCinf,u∙kel).
* as data permit.
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Table 3.
Urine PK Parameters
Parameter
Definition
Method of Determination
Ae24
Total amount of unchanged drug 
excreted in urine over 24 hours.
Sum of amount excreted for each 
collection period.
Ae24%
Total amount of unchanged drug 
excreted in urine over 24 hours, 
expressed as percent of dose.
100∙(Ae24/Dose)
CLr
Renal clearance.
Ae24/AUC24.
9.3.2.2. Main Analytical Approach
The effect of varying degrees of renal impairment on PK parameters will be assessed by 
constructing 90% CIs around the estimated difference between each of the Test (renal
impaired) groups and the Reference (without renal impairment) group. A one-way ANOVA 
will be used to compare the natural log transformed PF-07081532 AUCinf, Cmax, AUClast, fu, 
and associated unbound parameters (AUCinf,u, Cmax,u, AUClast,u), as data permit, for each of 
the renal impairment groups (Test) to the group without renal impairment (Reference). 
Estimates of the adjusted mean differences (Test - Reference), and corresponding 90% CIs, 
will be obtained from the model. These will be exponentiated to provide estimates of the 
ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Individual PF-07081532 concentrations will be listed and summarized descriptively by 
nominal PK sampling time and renal impairment group. Individual participant and summary 
profiles of the concentration-time data (using actual and nominal times, respectively) will be 
plotted by renal impairment group for both total plasma PF-07081532 and unbound 
PF-07081532.
Box and whisker plots for individual PK parameters (AUCinf, AUClast, Cmax, fu, AUCinf,u, 
AUClast,u and Cmax,u) will be constructed by renal impairment group and overlaid with 
geometric means. PK parameters of PF-07081532 will be listed and summarized 
descriptively by renal impairment group
For summary statistics and median or mean plots by sampling time, the nominal PK 
sampling time will be used. For individual partivipant plots by time, the actual PK sampling 
time will be used.
9.3.2.3. Supplementary Analyses
Linear regression may be used to characterize the potential relationship between appropriate 
PK parameters (eg, CL/F, CLu/F and CLr) for PF-07081532 and renal function (eGFR). 
eGFR values obtained on Day 1 will be included in the regression analysis. Estimates of the
statistical slope and intercept, together with their precision (90% CIs), and the coefficient of 
determination will be obtained from the model. 
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The effect of covariates such as weight, gender, and age may be explored, and details will be 
provided in the SAP.
Plots of PK parameters (eg, CL/F, CLu/F and CLr) for PF-07081532 versus renal function 
(eGFR as obtained on Day 1) will be constructed. A regression line and 90% confidence 
region for the PK parameters and eGFR will be included if appropriate. Vertical lines for the 
renal function group cut-off values will also be presented on the plots. Different symbols will 
be used to identify participants from different renal function groups.
Exploratory analyses, similar to those listed above (using the eGFR values determined with 
the 2021 CKD-EPI Scr-Scys combined equation) may be conducted using eGFR values
determined with the 2021 CKD-EPI Scr only, the Cockcroft-Gault or the MDRD formulas as 
described in the SAP.
9.3.3. Secondary Endpoint Analysis - Safety Analyses
All safety analyses will be performed on the safety population.
AEs, ECGs, BP, pulse rate, and safety laboratory data will be reviewed and summarized on 
an ongoing basis during the study to evaluate the safety of participants. Any clinical 
laboratory, ECG, BP, and pulse rate abnormalities of potential clinical concern will be 
described. Safety data will be presented in tabular and/or graphical format and summarized 
descriptively, where appropriate following sponsor standards.
Medical history and physical examination collected during the course of the study, will be 
considered source data and will not be required to be reported, unless otherwise noted. 
However, any untoward findings identified on physical examinations conducted during the 
active collection period will be captured as AEs, if those findings meet the definition of an 
AE. Data collected at screening that are used for inclusion/exclusion criteria, such as 
laboratory data, ECGs, and vital signs, will be considered source data, and will not be 
required to be reported, unless otherwise noted. Demographic data collected at screening will 
be reported. Alcohol test results will be considered source data and will not be required to be 
reported. COVID-19 specific assessment data will remain as source and will not be reported.
9.3.3.1. Electrocardiogram Analyses
Changes from baseline for the ECG parameters HR, QTcF, PR interval, and QRS complex 
will be summarized by treatment and time. The frequency of uncorrected QT values above 
500 ms will be tabulated.
The number (%) of participants with maximum post-dose QTcF values and maximum 
increases from baseline in the following categories will be tabulated by treatment: 
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These estimates are based on an assumed conservative standard deviation of 0.4 for 
logeAUCinf (also applicable to logeCmax) based on data from previous internal studies with 
PF-07081532 administered either as a single dose in the fed/fasted state in healthy 
participants (C3991001) or as multiple doses in the fed state in participants with T2DM 
(C3991002).
Participants who discontinue from the study before completing all assessments may be 
replaced at the discretion of the investigator and sponsor.
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10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations
10.1.1. Regulatory and Ethical Considerations
This study will be conducted in accordance with the protocol and with the following:
•
Consensus ethical principles derived from international guidelines, including the 
Declaration of Helsinki and CIOMS International Ethical Guidelines;
•
Applicable ICH GCP guidelines;
•
Applicable laws and regulations, including applicable privacy laws.
The protocol, protocol amendments, ICD, SRSD(s), and other relevant documents 
(eg, advertisements) must be reviewed and approved by the sponsor, submitted to an IRB/EC 
by the investigator, and reviewed and approved by the IRB/EC before the study is initiated.
Any amendments to the protocol will require IRB/EC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study participants.
Protocols and any substantial amendments to the protocol will require health authority 
approval prior to initiation except for changes necessary to eliminate an immediate hazard to 
study participants.
The investigator will be responsible for the following:
•
Providing written summaries of the status of the study to the IRB/EC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/EC;
•
Notifying the IRB/EC of SAEs or other significant safety findings as required by 
IRB/EC procedures;
•
Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH GCP guidelines, the IRB/EC, European regulation 
536/2014 for clinical studies, European Medical Device Regulation 2017/745 for 
clinical device research, and all other applicable local regulations.
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP
In the event of any prohibition or restriction imposed (ie, clinical hold) by an applicable 
regulatory authority in any area of the world, or if the investigator is aware of any new 
information that might influence the evaluation of the benefits and risks of the study 
intervention, Pfizer should be informed immediately.
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In addition, the investigator will inform Pfizer immediately of any urgent safety measures 
taken by the investigator to protect the study participants against any immediate hazard, and 
of any serious breaches of this protocol or of the ICH GCP guidelines that the investigator 
becomes aware of.
10.1.2. Financial Disclosure
Investigators and subinvestigators will provide the sponsor with sufficient, accurate financial 
information as requested to allow the sponsor to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities. Investigators 
are responsible for providing information on financial interests during the course of the study 
and for 1 year after completion of the study.
10.1.3. Informed Consent Process
The investigator or the investigator’s representative will explain the nature of the study, 
including the risks and benefits, to the participant and answer all questions regarding the 
study. The participant should be given sufficient time and opportunity to ask questions and to 
decide whether or not to participate in the trial.
Participants must be informed that their participation is voluntary. Participants will be 
required to sign a statement of informed consent that meets the requirements of 21 CFR 50, 
local regulations, ICH guidelines, privacy and data protection requirements, where 
applicable, and the IRB/EC or study center.
The investigator must ensure that each participant is fully informed about the nature and 
objectives of the study, the sharing of data related to the study, and possible risks associated 
with participation, including the risks associated with the processing of the participant’s 
personal data. 
The participant must be informed that their personal study-related data will be used by the
sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the participant.
The participant must be informed that their medical records may be examined by Clinical 
Quality Assurance auditors or other authorized personnel appointed by the sponsor, by 
appropriate IRB/EC members, and by inspectors from regulatory authorities.
The investigator further must ensure that each study participant is fully informed about their 
right to access and correct their personal data and to withdraw consent for the processing of 
their personal data.
The medical record must include a statement that written informed consent was obtained 
before the participant was enrolled in the study and the date on which the written consent was 
obtained. The authorized person obtaining the informed consent must also sign the ICD.
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Participants must be reconsented to the most current version of the IRB/EC-approved ICD(s) 
during their participation in the study as required per local regulations.
A copy of the ICD(s) must be provided to the participant.
Participants who are rescreened are required to sign a new ICD.
10.1.4. Data Protection
All parties will comply with all applicable laws, including laws regarding the implementation 
of organizational and technical measures to ensure protection of participant data.
Participants’ personal data will be stored at the study site in encrypted electronic and/or paper 
form and will be password protected or secured in a locked room to ensure that only 
authorized study staff have access. The study site will implement appropriate technical and 
organizational measures to ensure that the personal data can be recovered in the event of 
disaster. In the event of a potential personal data breach, the study site will be responsible for 
determining whether a personal data breach has in fact occurred and, if so, providing breach 
notifications as required by law.
To protect the rights and freedoms of participants with regard to the processing of personal 
data, participants will be assigned a single, participant--specific numerical code. Any 
participant records or data sets that are transferred to the sponsor will contain the numerical 
code; participant names will not be transferred. All other identifiable data transferred to the 
sponsor will be identified by this single, participant-specific code. The study site will 
maintain a confidential list of participants who participated in the study, linking each 
participant’s numerical code to their actual identity and medical record ID. In case of data 
transfer, the sponsor will protect the confidentiality of participants’ personal data consistent 
with the clinical study agreement and applicable privacy laws.
Information technology systems used to collect, process, and store study-related data are 
secured by technical and organizational security measures designed to protect such data 
against accidental or unlawful loss, alteration, or unauthorized disclosure or access.
The sponsor maintains standard operating procedures on how to respond in the event of 
unauthorized access, use, or disclosure of sponsor information or systems.
10.1.5. Committees Structure
A data monitoring committee or independent oversight committee will not be utilized.
10.1.5.1. Data Monitoring Committee 
This study will not use an E-DMC.
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10.1.6. Dissemination of Clinical Study Data
Pfizer fulfills its commitment to publicly disclose clinical study results through posting the 
results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), the EudraCT/CTIS, and/or 
www.pfizer.com, and other public registries and websites in accordance with applicable local 
laws/regulations. In addition, Pfizer reports study results outside of the requirements of local 
laws/regulations pursuant to its SOPs.
In all cases, study results are reported by Pfizer in an objective, accurate, balanced, and 
complete manner and are reported regardless of the outcome of the study or the country in 
which the study was conducted.
www.clinicaltrials.gov
Pfizer posts clinical trial results on www.clinicaltrials.gov for Pfizer-sponsored interventional 
studies (conducted in patients) that evaluate the safety and/or efficacy of a product, 
regardless of the geographical location in which the study is conducted. These results are 
submitted for posting in accordance with the format and timelines set forth by US law.
EudraCT/CTIS
Pfizer posts clinical trial results on EudraCT/CTIS for Pfizer-sponsored interventional studies 
in accordance with the format and timelines set forth by EU requirements.
www.pfizer.com
Pfizer posts CSR synopses and plain-language study results summaries on www.pfizer.com 
for Pfizer-sponsored interventional studies at the same time the corresponding study results 
are posted to www.clinicaltrials.gov. CSR synopses will have personally identifiable 
information anonymized.
Documents within marketing applications
Pfizer complies with applicable local laws/regulations to publish clinical documents included 
in marketing applications. Clinical documents include summary documents and CSRs 
including the protocol and protocol amendments, sample CRFs, and SAPs. Clinical 
documents will have personally identifiable information anonymized.
Data sharing
Pfizer provides researchers secure access to participant-level data or full CSRs for the 
purposes of “bona-fide scientific research” that contributes to the scientific understanding of 
the disease, target, or compound class. Pfizer will make data from these trials available 
24 months after study completion. Participant-level data will be anonymized in accordance 
with applicable privacy laws and regulations. CSRs will have personally identifiable 
information anonymized.
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Data requests are considered from qualified researchers with the appropriate competencies to 
perform the proposed analyses. Research teams must include a biostatistician. Data will not 
be provided to applicants with significant conflicts of interest, including individuals 
requesting access for commercial/competitive or legal purposes.
10.1.7. Data Quality Assurance
All participant data relating to the study will be recorded on printed or electronic CRF unless 
transmitted to the sponsor or designee electronically (eg, laboratory data). The investigator is 
responsible for verifying that data entries are accurate and correct by physically or 
electronically signing the CRF.
Guidance on completion of CRFs will be provided in the CRF Completion Requirements 
document.
The investigator must ensure that the CRFs are securely stored at the study site in encrypted 
electronic and/or paper form and are password-protected or secured in a locked room to 
prevent access by unauthorized third parties.
The investigator must permit study-related monitoring, audits, IRB/EC review, and 
regulatory agency inspections and provide direct access to source data documents. This 
verification may also occur after study completion. It is important that the investigator(s) and 
their relevant personnel are available during the monitoring visits and possible audits or 
inspections and that sufficient time is devoted to the process.
Monitoring details describing strategy, including definition of study-critical data items and 
processes (eg, risk-based initiatives in operations and quality, such as risk management and 
mitigation strategies and analytical risk-based monitoring), methods, responsibilities, and 
requirements, including handling of noncompliance issues and monitoring techniques 
(central, virtual, or on-site monitoring), are provided in the data management plan and 
monitoring plan maintained and utilized by the sponsor or designee.
The sponsor or designee is responsible for the data management of this study, including 
quality checking of the data.
Records and documents, including signed ICDs, pertaining to the conduct of this study must 
be retained by the investigator for 15 years after study completion unless local regulations or 
institutional policies require a longer retention period. No records may be destroyed during 
the retention period without the written approval of the sponsor. No records may be 
transferred to another location or party without written notification to the sponsor. The 
investigator must ensure that the records continue to be stored securely for as long as they are 
maintained.
When participant data are to be deleted, the investigator will ensure that all copies of such 
data are promptly and irrevocably deleted from all systems.
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The investigator(s) will notify the sponsor or its agents immediately of any regulatory 
inspection notification in relation to the study. Furthermore, the investigator will cooperate 
with the sponsor or its agents to prepare the investigator site for the inspection and will allow 
the sponsor or its agent, whenever feasible, to be present during the inspection. The 
investigator site and investigator will promptly resolve any discrepancies that are identified 
between the study data and the participant’s medical records. The investigator will promptly 
provide copies of the inspection findings to the sponsor or its agent. Before response 
submission to the regulatory authorities, the investigator will provide the sponsor or its 
agents with an opportunity to review and comment on responses to any such findings.
10.1.8. Source Documents
Source documents provide evidence for the existence of the participant and substantiate the 
integrity of the data collected. Source documents are filed at the investigator site.
Data reported on the CRF or entered in the eCRF that are from source documents must be 
consistent with the source documents or the discrepancies must be explained. The 
investigator may need to request previous medical records or transfer records, depending on 
the study. Also, current medical records must be available.
In this study, the CRF will serve as the source document. A document must be available at 
the investigative site that identifies those data that will be recorded on the CRF and for which 
the CRF will be the source document.
Definition of what constitutes source data and its origin can be found in the Source 
Document Locator, which is maintained by the sponsor.
Description of the use of the computerized system is documented in the Data Management 
Plan, which is maintained by the sponsor.
The investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRF.
The sponsor or designee will perform monitoring to confirm that data entered into the CRF 
by authorized site personnel are accurate, complete, and verifiable from source documents; 
that the safety and rights of participants are being protected; and that the study is being 
conducted in accordance with the currently approved protocol and any other study 
agreements, ICH GCP guidelines, and all applicable regulatory requirements.
10.1.9. Study and Site Start and Closure
The study start date is the date on which the clinical study will be open for recruitment of 
participants.
The first act of recruitment is the date of the first participant’s first visit and will be the study 
start date.
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The sponsor designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the sponsor, including (but not limited to) 
regulatory authority decision, change in opinion of the IRB/EC, or change in benefit-risk 
assessment. Study sites will be closed upon study completion. A study site is considered 
closed when all required documents and study supplies have been collected and a study-site 
closure visit has been performed.
The investigator may initiate study -site closure at any time upon notification to the sponsor
or designee/CRO if requested to do so by the responsible IRB/EC or if such termination is 
required to protect the health of study participants.
Reasons for the early closure of a study site by the sponsor may include but are not limited 
to:
•
Failure of the investigator to comply with the protocol, the requirements of the 
IRB/EC or local health authorities, the sponsor’s procedures, or the ICH GCP 
guidelines;
•
Inadequate recruitment of participants by the investigator;
•
Discontinuation of further study intervention development.
If the study is prematurely terminated or suspended, the sponsor shall promptly inform the 
investigators, the ECs/IRBs, the regulatory authorities, and any CRO(s) used in the study of 
the reason for termination or suspension, as specified by the applicable regulatory 
requirements. The investigator shall promptly inform the participant and should assure 
appropriate participant therapy and/or follow-up.
Study termination is also provided for in the clinical study agreement. If there is any conflict 
between the contract and this protocol, the contract will control as to termination rights.
10.1.10. Publication Policy
For multicenter trials, the primary publication will be a joint publication developed by the 
investigator and Pfizer reporting the primary endpoint(s) of the study covering all study sites. 
The investigator agrees to refer to the primary publication in any subsequent publications. 
Pfizer will not provide any financial compensation for the investigator’s participation in the 
preparation of the primary congress abstract, poster, presentation, or primary manuscript for 
the study.
Investigators are free to publish individual center results that they deem to be clinically 
meaningful after publication of the overall results of the study or 12 months after primary 
completion date or study completion at all sites, whichever occurs first, subject to the other 
requirements described in this section.
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The investigator will provide Pfizer an opportunity to review any proposed publication or 
any other type of disclosure of the study results (collectively, “publication”) before it is 
submitted or otherwise disclosed and will submit all publications to Pfizer 30 days before 
submission. If any patent action is required to protect intellectual property rights, the 
investigator agrees to delay the disclosure for a period not to exceed an additional 60 days 
upon request from Pfizer. This allows Pfizer to protect proprietary information and to provide 
comments, and the investigator will, on request, remove any previously undisclosed 
confidential information before disclosure, except for any study intervention or Pfizer-related 
information necessary for the appropriate scientific presentation or understanding of the 
study results. For joint publications, should there be disagreement regarding interpretation 
and/or presentation of specific analysis results, resolution of, and responsibility for, such 
disagreements will be the collective responsibility of all authors of the publication.
For all publications relating to the study, the investigator and Pfizer will comply with 
recognized ethical standards concerning publications and authorship, including those 
established by the International Committee of Medical Journal Editors. The investigator will 
disclose any relationship with Pfizer and any relevant potential conflicts of interest, including 
any financial or personal relationship with Pfizer, in any publications. All authors will have 
access to the relevant statistical tables, figures, and reports (in their original format) required 
to develop the publication.
10.1.11. Sponsor’s Medically Qualified Individual
The contact information for the sponsor’s MQI for the study is documented in the study 
contact list located in the supporting study documentation/study portal or other electronic 
system. 
To facilitate access to their investigator and the sponsor’s MQI for study-related medical 
questions or problems from nonstudy healthcare professionals, participants are provided with 
an ECC at the time of informed consent. The ECC contains, at a minimum, (a) protocol and 
study intervention identifiers, (b) participant’s study identification number, (c) site 
emergency phone number active 24 hours/day, 7 days per week, and (d) Pfizer Call Center 
number.
The ECC is intended to augment, not replace, the established communication pathways 
between the participant and their investigator and site staff, and between the investigator and 
sponsor study team. The ECC is only to be used by healthcare professionals not involved in 
the research study, as a means of reaching the investigator or site staff related to the care of a 
participant. The Pfizer Call Center number is to be used when the investigator and site staff 
are unavailable. The Pfizer Call Center number is not for use by the participant directly; if a 
participant calls that number directly, they will be directed back to the investigator site.
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10.2. Appendix 2: Clinical Laboratory Tests
The following safety laboratory tests will be performed at times defined in the SoA section of 
this protocol. Additional laboratory results may be reported on these samples as a result of 
the method of analysis or the type of analyzer used by the clinical laboratory, or as derived 
from calculated values. These additional tests would not require additional collection of 
blood. Unscheduled clinical laboratory measurements may be obtained at any time during the 
study to assess any perceived safety issues.
Table 5.
Protocol -Required Safety Laboratory Assessments
Hematology
Chemistry
Urinalysisi
Other
Hemoglobin
Hematocrit
RBC count
MCV
MCH
MCHC
Platelet count
WBC count
Total neutrophils (Abs)
Eosinophils (Abs)
Monocytes (Abs)
Basophils (Abs)
Lymphocytes (Abs)
BUN
Creatinine (Scr)
Cystatin C (Scys)
Plasma Glucose (fasting)
Calcium
Sodium
Potassium
Chloride
Magnesium
Phosphate
Total CO2 (Bicarbonate)
AST
ALT
Alkaline phosphatase
GGT
Total bilirubin
Direct bilirubina,b
Indirect bilirubina,b
Creatine kinasea,c
Uric acid
Albumin
Total protein
eGFRh
pH
Glucose (qual)
Protein (qual)
Blood (qual)
Ketones
Nitrites
Leukocyte 
esterase
Urobilinogen
Urine bilirubin
Microscopyd
At times specified in SoA:
•
Urine pregnancy test (WOCBP only)f
At Screening only:
•
Serum FSH (all females)
•
Serum pregnancy test (β‑hCG) (all
females)
•
Total bile acids
•
Amylase
•
Lipase
•
HbA1c
•
C-peptide
•
Urine drug testg
At screening and Day -1:
•
Breath alcohol teste
For suspected DILI:
•
AST, ALT
•
T bili, direct and indirect bilirubin
•
Total bile acids, GGT 
•
Albumin 
•
Alkaline phosphatase
•
CK 
•
PT, INR 
•
Acetaminophen/paracetamol or 
Protein adduct levels 
For suspected DICI/DIKI: 
•
Creatinine (Scr) 
•
CystatinC (Scys) 
•
eGFRh
•
Spot (dipstick) UACR
a.
At screening and Day 1, only. unless conditions for testing are met after Day 1 per notes “b” and “c” below.
b.
After Day 1, direct and indirect bilirubin assessed when total bilirubin is > ULN, only.
c.
After Day 1, creatine kinase assessed when ALT is > ULN, only.
d.
Only if urine dipstick is positive for blood, protein, nitrites, or leukocyte esterase.
e.
Testing to be done on-site using kits approved by sponsor. 
f.
Performed on-site using kits approved by sponsor. For a participant on dialysis who is anuric only, an alternative 
method (eg, serum) for urine testing may be used.
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g.
Minimum testing requirements include cocaine, THC, opiates and opioids, benzodiazepines and amphetamines. For 
a participant on dialysis who is anuric only, an alternative method (eg, saliva) for urine testing may be used.
h.
eGFR should be calculated using the 2021 CKD-EPI Scr-Scys combined equations; see Appendix 7.
i.
For a participant on dialysis who is anuric only, urinalysis is not required to be collected.
j.
For list of abbreviations, refer to Appendix 11.
The investigator must review the laboratory report, document this review, and record any 
clinically relevant changes occurring during the study in the AE section of the CRF.
Any remaining serum/plasma from samples collected for clinical safety laboratory 
measurements at baseline and at all times after dose administration may be retained and 
stored for the duration of the study. Upon completion of the study, these retained safety 
samples may be used for the assessment of exploratory safety biomarkers or unexpected 
safety findings. These data will not be included in the CSR. Samples to be used for this 
purpose will be shipped to either a Pfizer approved BBS facility or other designated 
laboratory and retained for up to 1 year following the completion of the study.
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Hospitalization for elective treatment of a preexisting condition that did not worsen 
from baseline is not considered an AE.
d. Results in persistent or significant disability/incapacity
•
The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions.
•
This definition is not intended to include experiences of relatively minor medical 
significance, such as uncomplicated headache, nausea, vomiting, diarrhea, 
influenza, and accidental trauma (eg, sprained ankle), that may interfere with or 
prevent everyday life functions but do not constitute a substantial disruption.
e.
Is a congenital anomaly/birth defect
f.
Is a suspected transmission via a Pfizer product of an infectious agent, pathogenic 
or non-pathogenic 
The event may be suspected from clinical symptoms or laboratory findings indicating 
an infection in a participant exposed to a Pfizer product. The terms “suspected 
transmission” and “transmission” are considered synonymous. These cases are 
considered unexpected and handled as serious expedited cases by pharmacovigilance 
personnel. Such cases are also considered for reporting as product defects, if 
appropriate.
g. Other situations:
•
Medical or scientific judgment should be exercised by the investigator in deciding 
whether SAE reporting is appropriate in other situations, such as significant 
medical events that may jeopardize the participant or may require medical or 
surgical intervention to prevent one of the other outcomes listed in the above 
definition. These events should usually be considered serious.
•
Examples of such events include invasive or malignant cancers, intensive treatment 
in an emergency room or at home for allergic bronchospasm, blood dyscrasias or 
convulsions that do not result in hospitalization, or development of drug 
dependency or drug abuse.
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10.4. Appendix 4: Contraceptive and Barrier Guidance
10.4.1. Male Participant Reproductive Inclusion Criteria
No contraception methods are required for male participants in this study, as the calculated 
safety margin is ≥100-fold between the estimated maternal exposure due to seminal transfer 
and the NOAEL for serious manifestations of developmental toxicity in nonclinical studies.
10.4.2. Female Participant Reproductive Inclusion Criteria
The criteria below are part of Inclusion Criterion 1 (Age and Sex; Section 5.1) and specify 
the reproductive requirements for including female participants. Refer to Section 10.4.4 for a 
complete list of contraceptive methods permitted in the study. 
A female participant is eligible to participate if she (a) is not pregnant or breastfeeding; 
(b) agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for 28 days after 
last dose of study intervention; and (c) at least 1 of the following conditions applies:
•
Is not a WOCBP (see definition in Section 10.4.3).
OR
•
Is a WOCBP who agrees to use a highly effective contraceptive method (failure rate 
of <1% per year) with low user dependency during the intervention period and for at 
least 28 days after the last dose of study intervention, which corresponds to the time 
needed to eliminate any reproductive safety risk of the study intervention(s). The 
investigator should evaluate the effectiveness of the contraceptive method in 
relationship to the first dose of study intervention.
OR
•
Is a WOCBP and agrees to use a highly effective (failure rate of <1% per year) 
user-dependent method of contraception during the intervention period and for at 
least 28 days after the last dose of study intervention, which corresponds to the time 
needed to eliminate any reproductive safety risk of the study intervention(s). In 
addition to her use of the highly effective method above, she agrees to concurrently
use an effective barrier method. The investigator should evaluate the effectiveness of 
the contraceptive method in relationship to the first dose of study intervention.
The investigator is responsible for reviewing the woman’s medical history, menstrual history, 
and recent sexual activity in order to decrease the risk of enrolling a woman with an early 
undetected pregnancy. 
10.4.3. Woman of Childbearing Potential
A woman is considered fertile following menarche and until becoming postmenopausal 
unless permanently sterile (see below).
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If fertility is unclear (eg, amenorrhea in adolescents or athletes) and a menstrual cycle cannot 
be confirmed before the first dose of study intervention, additional evaluation should be 
considered.
Women in the following categories are not considered WOCBP:
1. Premenopausal female with 1 of the following:
•
Documented hysterectomy;
•
Documented bilateral salpingectomy;
•
Documented bilateral oophorectomy.
For individuals with permanent infertility due to a medical cause other than the above
(eg, mullerian agenesis, androgen insensitivity), investigator discretion should be applied 
to determining study entry.
Note: Documentation for any of the above categories can come from the site personnel’s 
review of the participant’s medical records, medical examination, or medical history 
interview. The method of documentation should be recorded in the participant’s medical 
record for the study.
2. Postmenopausal female.
•
A postmenopausal state is defined as no menses for 12 months without an 
alternative medical cause. In addition:
•
A high FSH level in the postmenopausal range must be used to confirm a 
postmenopausal state in women under 60 years old and not using hormonal 
contraception or HRT. 
•
A female on HRT and whose menopausal status is in doubt will be required to 
use one of the highly effective nonestrogen hormonal contraception methods 
if she wishes to continue her HRT during the study. Otherwise, she must 
discontinue HRT to allow confirmation of postmenopausal status before study 
enrollment.
10.4.4. Contraception Methods
Contraceptive use by men or women should be consistent with local availability/regulations 
regarding the use of contraceptive methods for those participating in clinical trials.
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The following contraceptive methods are appropriate for this study:
Highly Effective Methods That Have Low User Dependency 
1. Implantable progestogen only hormone contraception associated with inhibition of 
ovulation.
2. Intrauterine device.
3. Intrauterine hormone releasing system.
4. Bilateral tubal occlusion.
5. Vasectomized partner.
•
Vasectomized partner is a highly effective contraceptive method provided that the 
partner is the sole sexual partner of the WOCBP and the absence of sperm has 
been confirmed. If not, an additional highly effective method of contraception 
should be used. The spermatogenesis cycle is approximately 90 days.
Highly Effective Methods That Are User Dependent 
6. Combined (estrogen and progestogen-containing) hormonal contraception associated 
with inhibition of ovulation:
•
Oral + barrier*.
•
Intravaginal + barrier*.
•
Transdermal + barrier*.
7. Progestogen only hormone contraception associated with inhibition of ovulation:
•
Oral + barrier*.
•
Injectable + barrier*.
8. Sexual Abstinence.
9. Sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated 
with the study intervention. The reliability of sexual abstinence needs to be evaluated 
in relation to the duration of the study and the preferred and usual lifestyle of the 
participant.
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* Acceptable barrier methods to be used concomitantly with options 6 or 7 for the study 
include any of the following:
•
Male or female condom with or without spermicide;
•
Cervical cap, diaphragm, or sponge with spermicide;
•
A combination of male condom with either cervical cap, diaphragm, or sponge with 
spermicide (double-barrier methods).
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10.5. Appendix 5: Genetics
Use/Analysis of DNA
•
Genetic variation may impact a participant’s response to study intervention, 
susceptibility to, and severity and progression of disease. Therefore, where local 
regulations and IRBs/ECs allow, a blood sample will be collected for DNA analysis.
•
The scope of the genetic research may be narrow (eg, 1 or more candidate genes) or
broad (eg, the entire genome), as appropriate to the scientific question under 
investigation.
•
The samples may be analyzed as part of a multistudy assessment of genetic factors 
involved in the response to PF-07081532 or study interventions of this class to 
understand treatments for the disease(s) under study or the disease(s) themselves.
•
The results of genetic analyses may be reported in the CSR or in a separate study 
summary, or may be used for internal decision making without being included in a 
study report.
•
The sponsor will store the DNA samples in a secure storage space with adequate 
measures to protect confidentiality. 
•
The samples will be retained as indicated:
•
Retained samples will be stored indefinitely or for another period as per local 
requirements.
•
Participants may withdraw their consent for the storage and/or use of their Retained 
Research Samples at any time by making a request to the investigator; in this case, 
any remaining material will be destroyed. Data already generated from the samples 
will be retained to protect the integrity of existing analyses.  
•
Samples for genetic research will be labeled with a code. The key between the code 
and the participant’s personally identifying information (eg, name, address) will be 
held securely at the study site.
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10.6. Appendix 6: Liver Safety: Suggested Actions and Follow-Up Assessments 
Potential Cases of Drug-Induced Liver Injury
Humans exposed to a drug who show no sign of liver injury (as determined by elevations in 
transaminases) are termed “tolerators,” while those who show transient liver injury but adapt 
are termed “adaptors.” In some participants, transaminase elevations are a harbinger of a 
more serious potential outcome. These participants fail to adapt and therefore are 
“susceptible” to progressive and serious liver injury, commonly referred to as DILI. 
Participants who experience a transaminase elevation above 3 × ULN should be monitored 
more frequently to determine if they are “adaptors” or are “susceptible.”
In the majority of DILI cases, elevations in AST and/or ALT precede T bili elevations 
(>2 × ULN) by several days or weeks. The increase in T bili typically occurs while 
AST/ALT is/are still elevated above 3 × ULN (ie, AST/ALT and T bili values will be 
elevated within the same laboratory sample). In rare instances, by the time T bili elevations 
are detected, AST/ALT values might have decreased. This occurrence is still regarded as a 
potential DILI. Therefore, abnormal elevations in either AST OR ALT in addition to T bili 
that meet the criteria outlined below are considered potential DILI (assessed per Hy’s law 
criteria) cases and should always be considered important medical events, even before all 
other possible causes of liver injury have been excluded.
The threshold of laboratory abnormalities for a potential DILI case depends on the 
participant’s individual baseline values and underlying conditions. Participants who present 
with the following laboratory abnormalities should be evaluated further as potential DILI 
(Hy’s law) cases to definitively determine the etiology of the abnormal laboratory values:
•
Participants with AST/ALT and T bili baseline values within the normal range who 
subsequently present with AST OR ALT values ≥3 × ULN AND a T bili value 
≥2 × ULN with no evidence of hemolysis and an alkaline phosphatase value 
<2 × ULN or not available.
•
For participants with baseline AST OR ALT OR T bili values above the ULN, the 
following threshold values are used in the definition mentioned above, as needed, 
depending on which values are above the ULN at baseline:
•
Preexisting AST or ALT baseline values above the normal range: AST or ALT 
values ≥2 times the baseline values AND ≥3 × ULN; or ≥8 × ULN (whichever is 
smaller).
•
Preexisting values of T bili above the normal range: T bili level increased from 
baseline value by an amount of ≥1 × ULN or if the value reaches ≥3 × ULN 
(whichever is smaller).
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Rises in AST/ALT and T bili separated by more than a few weeks should be assessed 
individually based on clinical judgment; any case where uncertainty remains as to whether it 
represents a potential Hy’s law case should be reviewed with the sponsor. 
The participant should return to the investigator site and be evaluated as soon as possible, 
preferably within 48 hours from awareness of the abnormal results. This evaluation should 
include laboratory tests, detailed history, and physical assessment. 
In addition to repeating measurements of AST and ALT and T bili for suspected Hy’s law 
cases, additional laboratory tests should include albumin, CK, direct and indirect bilirubin, 
GGT, PT/INR, total bile acids, and alkaline phosphatase. Consideration should also be given 
to drawing a separate tube of clotted blood and an anticoagulated tube of blood for further 
testing, as needed, for further contemporaneous analyses at the time of the recognized initial 
abnormalities to determine etiology. A detailed history, including relevant information, such 
as review of ethanol, acetaminophen/paracetamol (either by itself or as a coformulated 
product in prescription or over-the-counter medications), recreational drug, or supplement 
(herbal) use and consumption, family history, sexual history, travel history, history of contact 
with a jaundiced person, surgery, blood transfusion, history of liver or allergic disease, and 
potential occupational exposure to chemicals, should be collected. Further testing for acute 
hepatitis A, B, C, D, and E infection, liver imaging (eg, biliary tract), and collection of serum 
samples for acetaminophen/paracetamol drug and/or protein adduct levels may be warranted. 
All cases demonstrated on repeat testing as meeting the laboratory criteria of AST/ALT and 
T bili elevation defined above should be considered potential DILI (Hy’s law) cases if no 
other reason for the LFT abnormalities has yet been found. Such potential DILI (Hy’s law) 
cases are to be reported as SAEs, irrespective of availability of all the results of the 
investigations performed to determine etiology of the LFT abnormalities.
A potential DILI (Hy’s law) case becomes a confirmed case only after all results of 
reasonable investigations have been received and have excluded an alternative etiology.
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10.7. Appendix 7: Kidney Safety: Monitoring Guidelines
10.7.1. Laboratory Assessment of Change in Kidney Function and Detection of Kidney 
Injury
Standard kidney safety monitoring requires assessment of baseline and postbaseline serum 
creatinine. Additionally, baseline and postbaseline serum Scys makes it feasible to 
distinguish AKI from other causes of Scr increase. In this study, eGFR will be determined
using the 2021 CKD-EPI Scr-Scys combined equation (see Table below) and both Scr and 
Scys will be measured as part of the protocol-required safety laboratory assessments at all 
times specified in the SoA.
Regardless of whether kidney function monitoring tests are required as a routine safety 
monitoring procedure in the study, if the investigator or sponsor deems it necessary to further 
assess kidney safety and quantify kidney function, then these test results should be managed 
and followed per standard of care.
10.7.2. Age-Specific Kidney Function Calculation Recommendations
10.7.2.1. Adults (18 Years and Above)—2021 CKD-EPI Equations14
2021 CKD-EPI 
Scr-Scys 
Combined
Scr
(mg/dL)
Scys
(mg/L)
Recommended eGFR Equation
Female
if ≤0.7
if ≤0.8
eGFR = 130 × (Scr/0.7)-0.219 × (Scys/0.8)-0.323 × (0.9961)Age
Female
if ≤0.7
if >0.8
eGFR = 130 × (Scr/0.7)-0.219 × (Scys/0.8)-0.778 × (0.9961)Age
Female
if >0.7
if ≤0.8
eGFR = 130 × (Scr/0.7)-0.544 × (Scys/0.8)-0.323 × (0.9961)Age
Female
if >0.7
if >0.8
eGFR = 130 × (Scr/0.7)-0.544 × (Scys/0.8)-0.778 × (0.9961)Age
Male
if ≤0.9
if ≤0.8
eGFR = 135 × (Scr/0.9)-0.144 × (Scys/0.8)-0.323 × (0.9961)Age
Male
if ≤0.9
if >0.8
eGFR = 135 × (Scr/0.9)-0.144 × (Scys/0.8)-0.778 × (0.9961)Age
Male
if >0.9
if ≤0.8
eGFR = 135 × (Scr/0.9)-0.544 ×  (Scys/0.8)-0.323 × (0.9961)Age
Male
if >0.9
if >0.8
eGFR = 135 × (Scr/0.9)-0.544 ×  (Scys/0.8)-0.778 × (0.9961)Age
10.7.3. Adverse Event Grading for Kidney Safety Laboratory Abnormalities
AE grading for decline in kidney function (ie, eGFR or eCrCl) will be according to KDIGO
criteria.
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10.9. Appendix 9: Prohibited Concomitant Medications That May Result in DDI  
The prohibited concomitant medications listed below should not be taken with PF-07081532
for the period of time at least equal to the required washout period listed in the table, and 
throughout the conduct of the study. 
The Pfizer study team is to be notified of any prohibited medications taken during the study. 
After consulting with the sponsor, the investigator will make a judgment on the ongoing 
participation of any participant with prohibited medication use during the study.
This list of drugs prohibited for potential DDI concerns with the IMP may be revised during 
the course of the study with written notification from sponsor, to include or exclude specific 
drugs or drug categories for various reasons (eg, emerging DDI results for the IMP, 
availability of new information in literature on the DDI potential of other drugs). 
This is not an all-inclusive list. Site staff should consult with the sponsor or designee 
with any questions regarding potential DDI.
Investigators should consult the product label for any other medication used during the study 
for information regarding medication that is prohibited for concomitant use. 
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10.11. Appendix 11: Abbreviations
The following is a list of abbreviations that may be used in the protocol. 
Abbreviation
Term
Abs
absolute
ADL
activity/activities of daily living
AE
adverse event
AKI
acute kidney injury
ALT
alanine aminotransferase
ANOVA
Analysis of variance
AST
aspartate aminotransferase
AUC
area under the curve
AV
atrioventricular
AxMP
auxiliary medicinal product
BBS
Biospecimen Banking System
β-hCG
β-human chorionic gonadotropin
BMI
body mass index
BP
blood pressure
bpm
beats per minute
BSA
body surface area
BUN
blood urea nitrogen
cAMP
cyclic adenosine monophosphate
CFR
Code of Federal Regulations
CI
confidence interval
CIOMS
Council for International Organizations of Medical Sciences
CK
creatine kinase
CKD
chronic kidney disease
CKD-EPI
chronic kidney disease epidemiology
CL
clearance
CL/F
apparent clearance
CLu/F
unbound CL/F
Cmax
maximum plasma concentration
Cmax,u
unbound Cmax
CO2
carbon dioxide (bicarbonate)
COVID-19
coronavirus disease 2019
CRF
case report form
CRO
contract research organization
CRU
clinical research unit
CSR
Clinical Study Report
CT
clinical trial
CTIS
Clinical Trial Information System
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Abbreviation
Term
DBP
diastolic blood pressure
DCT
data collection tool
DDI
drug-drug interaction 
DHT
digital health technology
DICI
drug-induced creatinine increase
DIKI
drug-induced kidney injury
DILI
drug-induced liver injury
DNA
deoxyribonucleic acid
EC
ethics committee
ECC
emergency contact card
ECG
electrocardiogram or electrocardiography
eCrCl
estimated creatinine clearance
eCRF
electronic case report form
EDB
exposure during breastfeeding
E-DMC
External Data Monitoring Committee
EDP
exposure during pregnancy
EFD
embryo fetal development
eGFR
estimated glomerular filtration rate
EOT
end of treatment
eSAE
electronic serious adverse event
EU
European Union
EudraCT
European Union Drug Regulating Authorities Clincal Trials 
(European Clinical Trials Database)
FDA
Food and Drug Administration
FIH
first-in-human
FPG
fasting plasma glucose
FSBG
fingerstick blood glucose
FSH
follicle-stimulating hormone
fu
fraction unbound in plasma/unbound fraction
GCP
Good Clinical Practice
GGT
gamma-glutamyl transferase
GI
gastrointestinal 
GLP-1
glucagon-like peptide-1
GLP-1R
glucagon-like peptide-1 receptor
H
hour
HbA1c
hemoglobin A1c
HAE
hypoglycemic adverse event(s)
HR
heart rate
HRT
hormone replacement therapy
IB
Investigator’s Brochure
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CCI

PF-07081532
Protocol C3991007
Final Protocol, 03 June 2022
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Pharmacology Protocol Template (01 April 2022)
TMF Doc ID: 164.01
Page 103
Abbreviation
Term
ICD
informed consent document
ICH
International Council for Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use
ID
identification
IMP
investigational medicinal product
IND
Investigational New Drug 
INR
international normalized ratio
IP
investigational product
IPAL
Investigational Product Accountability Log
IPM
investigational product manual
IRB
Institutional Review Board
IV
Intravenous(ly)
IVGTT
intravenous glucose tolerance test
K2EDTA
ethylene diamine tetraacetic acid
KDIGO
Kidney Disease Improving Global Outcomes
LBBB
left bundle branch block
LFT
liver function test
MCH
mean corpuscular hemoglobin
MCHC
mean corpuscular hemoglobin concentration
MCV
mean corpuscular volume
MDRD
modification of diet in renal disease
MEN2
multiple endocrine neoplasia type 2
MOA
mechanism of action
MQI
medically qualified individual
MTC
medullary thyroid cancer
N/A
not applicable
NIMP
noninvestigational medicinal product
NOAEL
no-observed-adverse-effect level
NRU
neutral red uptake
PD
pharmacodynamic(s)
PE
physical examination
PI
principal investigator
PK
pharmacokinetic(s)
PO
oral
PR
pulse rate
PSSA
Pfizer's Serious Adverse Event Submission Assistant
PT
prothrombin time
PVC
premature ventricular contraction/complex
QD
once daily
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CCI
CCI

PF-07081532
Protocol C3991007
Final Protocol, 03 June 2022
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Pharmacology Protocol Template (01 April 2022)
TMF Doc ID: 164.01
Page 104
Abbreviation
Term
QTc
corrected QT interval
QTcF
QTc corrected using Fridericia’s formula
qual
qualitative
RBC
red blood cell
RNA
ribonucleic acid
S1
Screening visit 1
S2
Screening visit 2
SAE
serious adverse event
SAP
Statistical Analysis Plan
SARS-CoV-2
severe acute respiratory syndrome coronavirus 2
SBP
systolic blood pressure
Scr
serum creatinine
Scys
serum cystatin C
SoA
schedule of activities
SOC
system organ class
SOP
standard operating procedure
SRSD
Single Reference Safety Document
SSID
study-specific identification
SUSAR
Suspected Unexpected Serious Adverse Reaction
T2DM
type 2 Diabetes Mellitus
t½
terminal half-life
T bili
total bilirubin
THC
tetrahydrocannabinol
Tmax
time for Cmax
UACR
urine albumin/creatinine ratio
ULN
upper limit of normal
US
United States
VZ/F
apparent volume of distribution 
Vz,u/F
unbound Vz/F
WBC
white blood cell
WOCBP
woman/women of childbearing potential
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CCI

PF-07081532
Protocol C3991007
Final Protocol, 03 June 2022
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Pharmacology Protocol Template (01 April 2022)
TMF Doc ID: 164.01
Page 106
14.
Inker LA et al. N Engl J Med. 2021;385:1737-49.
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