Back to resultsTrial to Learn About the Study Medicine (PF-07081532) and Rybelsus in People With Type 2 Diabetes and Separately PF-07081532 in People With Obesity
Primary Purpose
Diabetes Mellitus, Obesity
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-07081532
Placebo
Rybelsus
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes Mellitus, Obesity
Eligibility Criteria
Inclusion Criteria:
T2DM
- T2DM inadequately controlled with metformin
- BMI ≥23.0 kg/m2 (≥20.0 kg/m2 in Japan)
- HbA1C of 7% to 10% (53-86 mmol/mol)
- FPG ≤270 mg/dL (15 mmol/L) Obesity
- BMI ≥30.0 kg/m2
- HbA1C ≤6.4% (47 mmol/mol)
- FPG ≤126 mg/dL (7 mmol/L)
Exclusion Criteria:
- Any of the following: Active/current, symptomatic gallbladder disease; History of pancreatitis in the prior 2-months;History of Type 1 Diabetes Mellitus, or secondary forms of diabetes; Any condition affecting drug absorption; Medical history of active liver disease (other than non-alcoholic hepatic steatosis)
- Use of pharmacological agents with approved indication for weight loss
- T2DM:Use of any agent (other than metformin)for the explicit purpose of glycemic control;History of diabetic ketoacidosis;Proliferative retinopathy or maculopathy requiring acute treatment;
- Obesity: Previous or planned weight reduction surgery; Major depressive disorder or other severe psychiatric disorders; Any lifetime history of a suicide attempt; PHQ-9 score ≥15; Response of "yes" to Question 4 or 5, or on any suicidal behavioral question on the C-SSRS
- Clinically significant cardiovascular conditions
- Uncontrolled blood pressure
- Personal or within first-degree relative family history of MTC or MEN2
- Other medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
- Any of the following central lab results:
Fasting C-peptide <0.8 ng/mL; ALT or AST ≥2.5x ULN; Direct bilirubin >ULN or T Bili >1.5x ULN except when participants have a history of Gilbert syndrome ; TSH >1.5x ULN or <LLN; Serum calcitonin >ULN; Serum amylase or serum lipase >ULN; eGFR <45 ml/min/1.73 ; Active Hepatitis B, or Hepatitis C; A positive urine drug test for illicit drugs
Sites / Locations
- Trinity Clinical Research
- Anaheim Clinical Trials, LLC
- San Fernando Valley Health Institute
- Catalina Research Institute, LLC
- Empire Clinical Research
- University Clinical Investigators, Inc.
- Diablo Clinical Research, Inc.
- Innovative Research of West Florida
- Jacksonville Center for Clinical Research
- Adult Medicine of Lake County
- Endocrine Research Solutions, Inc.
- Cedar Crosse Research Center
- Evanston Premier Healthcare Research LLC
- Iowa Diabetes and Endocrinology Research Center
- Anderson Medical Research
- StudyMetrix Research
- Mercury Street Medical Group, PLLC
- Hassman Research Institute
- Premier Research
- Medication Management
- Meridian Clinical Research, LLC
- Alliance for Multispecialty Research, LLC
- Heritage Valley Multispecialty Group, Inc
- Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
- Preferred Primary Care Physicians
- Velocity Clinical Research, Providence
- HealthStar Physicians, P.C.
- Healthstar Physicians
- Elligo Clinical Research Center
- Velocity Clinical Research, Dallas
- UT Southwestern Medical Center
- Medical Colleagues of Texas, LLP
- Tapia Internal Medicine Clinic
- Northeast Clinical Research of San Antonio
- Consano Clinical Research, LLC
- Sugar Lakes Family Practice
- Chrysalis Clinical Research
- Southwest Internal Medicine
- Manassas Clinical Research Center
- Medical Centre "Asklepiy"
- Diagnostic Consultative Center Aleksandrovska
- MHAT Botevgrad
- Medical Center Zdrave 1
- "Prevencia - 2000 - Medical Center for Prehospital Medical Care" OOD
- Dr. M.B. Jones Inc.
- G A Research Associates
- Aggarwal and Associates Limited
- Dawson Clinical Research
- Milestone Research Inc.
- Bluewater Clinical Research Group Inc.
- LMC Clinical Research Inc. (Bayview)
- Manna Research Mirabel
- Diex Recherche Victoriavile Inc.
- Diex Recherche Quebec Inc.
- Centre de Recherche Saint-Louis
- MUDr. Alena Vachova
- EDUMED s.r.o.
- Kardiologicka a Angiologicka Ambulance
- Agentura Science Pro
- Private Practice - Dr. Tomáš Brychta
- EUC Klinika Praha
- Clinical Trials Service s.r.o.
- Belinus Orvosi és Számitástechnikai Bt
- Borbánya Praxis
- CLINFAN Szolgáltató Kft
- DRC Gyógyszervizsgáló Központ
- ClinDiab Kft.
- Debreceni Egyetem Klinikai Kozpont
- Nakakinen clinic
- Yokohama Minoru Clinic
- Shiraiwa Medical Clinic
- Medical Corporation Heishinkai OCROM Clinic
- Seiwa Clinic
- Seiwa Clinic
- Tokyo-Eki Center-building Clinic
- Medical Corporation Chiseikai Tokyo Center Clinic
- Fukuwa Clinic
- Medical Corporation Heishinkai ToCROM Clinic
- Yokohama Minoru Clinic
- KO-MED Centra Kliniczne Pulawy
- Oświęcimskie Centrum Badań Klinicznych
- Zdrowie Osteo-Medic
- Centrum Badan Klinicznych PI-House sp. z o.o.
- Centrum Zdrowia Metabolicznego Pawel Bogdanski
- Gabinet Lekarski Małgorzata Jadwiga Saryusz-Wolska
- NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
- Latin Clinical Trial Center
- GCM Medical Group, PSC - Hato Rey Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
PF-07081532 20 mg T2DM
PF-07081532 40 mg T2DM
PF-07081532 80 mg T2DM
PF-07081532 160 mg T2DM
PF-07081532 260 mg T2DM
Placebo T2DM
PF-07081532 80 mg Obesity
PF-07081532 140 mg Obesity
PF-07081532 200 mg Obesity (Option 1)
PF-07081532 200 mg Obesity (Option 2)
PF-07081532 260 mg Obesity
Rybelsus 14 mg T2DM
Placebo Obesity
Arm Description
PF-07081532 20 mg daily in T2DM
PF-07081532 40 mg daily in T2DM
PF-07081532 80 mg daily in T2DM
PF-07081532 160 mg daily in T2DM
PF-07081532 260 mg daily in T2DM
Placebo daily in T2DM
PF-07081532 80 mg daily in Obesity
PF-07081532 140 mg daily in Obesity
PF-07081532 200 mg daily in Obesity
PF-07081532 200 mg daily in Obesity
PF-07081532 260 mg daily in Obesity
Semaglutide 14 mg daily in T2DM
Placebo in Obesity
Outcomes
Primary Outcome Measures
Placebo-adjusted, change from baseline in Hemoglobin A1c (HbA1c) at Week 32 in Type 2 Diabetes Mellitus (T2DM)
Placebo-adjusted, percent change from baseline in body weight at Week 32 in Obesity
Secondary Outcome Measures
Proportion of participants who achieve HbA1C <7% (<53 mmol/mol) at Week 32 in T2DM
Placebo-adjusted, change from baseline in FPG at Week 32 in T2DM
Placebo-adjusted, percent change from baseline in body weight at Week 32 in T2DM
Placebo-adjusted, change from baseline in HbA1C at Week 32 with Rybelsus in T2DM
Proportion of participants achieving ≥5% body weight loss at Week 32 relative to baseline in Obesity
Proportion of participants achieving ≥10% body weight loss at Week 32 relative to baseline in Obesity
Proportion of participants achieving≥15% body weight loss at Week 32 relative to baseline in Obesity
Placebo-adjusted, absolute change from baseline in waist circumference at Week 32 in Obesity
Placebo-adjusted, absolute change from baseline in waist-to hip ratio at Week 32 in Obesity
Placebo-adjusted, change from baseline in Homeostatic Model Assessment for Insulin Resistance at Week 32 in Obesity
Placebo-adjusted, change from baseline in Homeostatic Model Assessment for Insulin Sensitivity at Week 32 in Obesity
To compare PF 07081532 to placebo in the number of participants reporting Adverse Events
To compare PF 07081532 to placebo in the number of participants reporting Serious Adverse Events
To compare PF 07081532 to placebo in the number of participants reporting Adverse Events leading to discontinuation
To compare PF 07081532 to placebo in the number of participants reporting Hypoglycemia
To compare PF 07081532 to placebo in the number of participants with clinical laboratory abnormalities
To compare PF 07081532 to placebo in the number of participants with vital sign abnormalities
To compare PF 07081532 to placebo in the number of participants with ECG abnormalities
Assessment of mental health as determined by Columbia-Suicide Severity Rating Scale (C-SSRS) in Obesity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05579977
Brief Title
Trial to Learn About the Study Medicine (PF-07081532) and Rybelsus in People With Type 2 Diabetes and Separately PF-07081532 in People With Obesity
Official Title
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, DOSE RANGING, DOSE FINDING, PARALLEL GROUP STUDY TO ASSESS EFFICACY AND SAFETY OF PF-07081532, AND OPEN LABEL ORAL SEMAGLUTIDE, IN ADULTS WITH TYPE 2 DIABETES MELLITUS (T2DM) INADEQUATELY CONTROLLED ON METFORMIN, AND SEPARATELY PF-07081532 COMPARED TO MATCHING PLACEBO IN ADULTS WITH OBESITY BUT WITHOUT T2DM
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
The decision to terminate clinical development of PF-07081532 is based on pharmacokinetic data from Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as a Phase 2 study.
Study Start Date
October 27, 2022 (Actual)
Primary Completion Date
September 22, 2023 (Actual)
Study Completion Date
September 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to find out if PF-07081532 ("the active study drug"), is safe and helps treat people with obesity without diabetes to lose weight, and people with diabetes to keep their blood sugar in good control. Individuals diagnosed with diabetes that are on metformin or individuals with obesity without diabetes will be included in the study.
Those participating in the diabetes part of the study, will receive either active study drug, placebo, or an approved treatment called Rybelsus. Those in the obesity part of the study, will receive either active study drug or placebo. The study will last for about 36 weeks except for the first 25% of the participants that enter in which case the study will last for approximately 48 weeks. during this time there will be visits every 4 weeks with phone calls in between.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Obesity
Keywords
Diabetes Mellitus, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
902 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PF-07081532 20 mg T2DM
Arm Type
Experimental
Arm Description
PF-07081532 20 mg daily in T2DM
Arm Title
PF-07081532 40 mg T2DM
Arm Type
Experimental
Arm Description
PF-07081532 40 mg daily in T2DM
Arm Title
PF-07081532 80 mg T2DM
Arm Type
Experimental
Arm Description
PF-07081532 80 mg daily in T2DM
Arm Title
PF-07081532 160 mg T2DM
Arm Type
Experimental
Arm Description
PF-07081532 160 mg daily in T2DM
Arm Title
PF-07081532 260 mg T2DM
Arm Type
Experimental
Arm Description
PF-07081532 260 mg daily in T2DM
Arm Title
Placebo T2DM
Arm Type
Placebo Comparator
Arm Description
Placebo daily in T2DM
Arm Title
PF-07081532 80 mg Obesity
Arm Type
Experimental
Arm Description
PF-07081532 80 mg daily in Obesity
Arm Title
PF-07081532 140 mg Obesity
Arm Type
Experimental
Arm Description
PF-07081532 140 mg daily in Obesity
Arm Title
PF-07081532 200 mg Obesity (Option 1)
Arm Type
Experimental
Arm Description
PF-07081532 200 mg daily in Obesity
Arm Title
PF-07081532 200 mg Obesity (Option 2)
Arm Type
Experimental
Arm Description
PF-07081532 200 mg daily in Obesity
Arm Title
PF-07081532 260 mg Obesity
Arm Type
Experimental
Arm Description
PF-07081532 260 mg daily in Obesity
Arm Title
Rybelsus 14 mg T2DM
Arm Type
Active Comparator
Arm Description
Semaglutide 14 mg daily in T2DM
Arm Title
Placebo Obesity
Arm Type
Placebo Comparator
Arm Description
Placebo in Obesity
Intervention Type
Drug
Intervention Name(s)
PF-07081532
Intervention Description
Oral glucagon-like peptide-1 receptor agonist
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
No drug
Intervention Type
Drug
Intervention Name(s)
Rybelsus
Intervention Description
Oral Semaglutide
Primary Outcome Measure Information:
Title
Placebo-adjusted, change from baseline in Hemoglobin A1c (HbA1c) at Week 32 in Type 2 Diabetes Mellitus (T2DM)
Time Frame
baseline, week 32
Title
Placebo-adjusted, percent change from baseline in body weight at Week 32 in Obesity
Time Frame
baseline, week 32
Secondary Outcome Measure Information:
Title
Proportion of participants who achieve HbA1C <7% (<53 mmol/mol) at Week 32 in T2DM
Time Frame
week 32
Title
Placebo-adjusted, change from baseline in FPG at Week 32 in T2DM
Time Frame
baseline, week 32
Title
Placebo-adjusted, percent change from baseline in body weight at Week 32 in T2DM
Time Frame
baseline, week 32
Title
Placebo-adjusted, change from baseline in HbA1C at Week 32 with Rybelsus in T2DM
Time Frame
baseline, week 32
Title
Proportion of participants achieving ≥5% body weight loss at Week 32 relative to baseline in Obesity
Time Frame
baseline, week 32
Title
Proportion of participants achieving ≥10% body weight loss at Week 32 relative to baseline in Obesity
Time Frame
Week 32
Title
Proportion of participants achieving≥15% body weight loss at Week 32 relative to baseline in Obesity
Time Frame
Week 32
Title
Placebo-adjusted, absolute change from baseline in waist circumference at Week 32 in Obesity
Time Frame
baseline, week 32
Title
Placebo-adjusted, absolute change from baseline in waist-to hip ratio at Week 32 in Obesity
Time Frame
baseline, week 32
Title
Placebo-adjusted, change from baseline in Homeostatic Model Assessment for Insulin Resistance at Week 32 in Obesity
Time Frame
baseline, week 32
Title
Placebo-adjusted, change from baseline in Homeostatic Model Assessment for Insulin Sensitivity at Week 32 in Obesity
Time Frame
baseline, week 32
Title
To compare PF 07081532 to placebo in the number of participants reporting Adverse Events
Time Frame
week 36 and 48
Title
To compare PF 07081532 to placebo in the number of participants reporting Serious Adverse Events
Time Frame
week 36, week 48
Title
To compare PF 07081532 to placebo in the number of participants reporting Adverse Events leading to discontinuation
Time Frame
week 36, week 48
Title
To compare PF 07081532 to placebo in the number of participants reporting Hypoglycemia
Time Frame
Week 36, week 48
Title
To compare PF 07081532 to placebo in the number of participants with clinical laboratory abnormalities
Time Frame
Week 36, week 48
Title
To compare PF 07081532 to placebo in the number of participants with vital sign abnormalities
Time Frame
Week 36, Week 48
Title
To compare PF 07081532 to placebo in the number of participants with ECG abnormalities
Time Frame
Week 34, week 46
Title
Assessment of mental health as determined by Columbia-Suicide Severity Rating Scale (C-SSRS) in Obesity
Time Frame
Week 32 and 44
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
T2DM
T2DM inadequately controlled with metformin
BMI ≥23.0 kg/m2 (≥20.0 kg/m2 in Japan)
HbA1C of 7% to 10% (53-86 mmol/mol)
FPG ≤270 mg/dL (15 mmol/L)
Obesity
BMI ≥30.0 kg/m2
HbA1C ≤6.4% (47 mmol/mol)
FPG ≤126 mg/dL (7 mmol/L)
Exclusion Criteria:
Any of the following: Active/current, symptomatic gallbladder disease; History of pancreatitis in the prior 2-months;History of Type 1 Diabetes Mellitus, or secondary forms of diabetes; Any condition affecting drug absorption; Medical history of active liver disease (other than non-alcoholic hepatic steatosis)
Use of pharmacological agents with approved indication for weight loss
T2DM:Use of any agent (other than metformin)for the explicit purpose of glycemic control;History of diabetic ketoacidosis;Proliferative retinopathy or maculopathy requiring acute treatment;
Obesity: Previous or planned weight reduction surgery; Major depressive disorder or other severe psychiatric disorders; Any lifetime history of a suicide attempt; PHQ-9 score ≥15; Response of "yes" to Question 4 or 5, or on any suicidal behavioral question on the C-SSRS
Clinically significant cardiovascular conditions
Uncontrolled blood pressure
Personal or within first-degree relative family history of MTC or MEN2
Other medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
Any of the following central lab results: Fasting C-peptide <0.8 ng/mL; ALT or AST ≥2.5x ULN; Direct bilirubin >ULN or T Bili >1.5x ULN except when participants have a history of Gilbert syndrome ; TSH >1.5x ULN or <LLN; Serum calcitonin >ULN; Serum amylase or serum lipase >ULN; eGFR <45 ml/min/1.73 ; Active Hepatitis B, or Hepatitis C; A positive urine drug test for illicit drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Trinity Clinical Research
City
Centreville
State/Province
Alabama
ZIP/Postal Code
35042
Country
United States
Facility Name
Anaheim Clinical Trials, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
San Fernando Valley Health Institute
City
Canoga Park
State/Province
California
ZIP/Postal Code
91304
Country
United States
Facility Name
Catalina Research Institute, LLC
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
Empire Clinical Research
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
University Clinical Investigators, Inc.
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Innovative Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Adult Medicine of Lake County
City
Mount Dora
State/Province
Florida
ZIP/Postal Code
32757
Country
United States
Facility Name
Endocrine Research Solutions, Inc.
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Cedar Crosse Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Evanston Premier Healthcare Research LLC
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Iowa Diabetes and Endocrinology Research Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Anderson Medical Research
City
Fort Washington
State/Province
Maryland
ZIP/Postal Code
20744
Country
United States
Facility Name
StudyMetrix Research
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
Mercury Street Medical Group, PLLC
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Premier Research
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08611
Country
United States
Facility Name
Medication Management
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Heritage Valley Multispecialty Group, Inc
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Preferred Primary Care Physicians
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Velocity Clinical Research, Providence
City
East Greenwich
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Facility Name
HealthStar Physicians, P.C.
City
Morristown
State/Province
Tennessee
ZIP/Postal Code
37813
Country
United States
Facility Name
Healthstar Physicians
City
Morristown
State/Province
Tennessee
ZIP/Postal Code
37813
Country
United States
Facility Name
Elligo Clinical Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78738
Country
United States
Facility Name
Velocity Clinical Research, Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Medical Colleagues of Texas, LLP
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Facility Name
Tapia Internal Medicine Clinic
City
Paris
State/Province
Texas
ZIP/Postal Code
75462
Country
United States
Facility Name
Northeast Clinical Research of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
Consano Clinical Research, LLC
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Facility Name
Sugar Lakes Family Practice
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Chrysalis Clinical Research
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
Southwest Internal Medicine
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
Manassas Clinical Research Center
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
Medical Centre "Asklepiy"
City
Dupnitsa
State/Province
Kyustendil
ZIP/Postal Code
2600
Country
Bulgaria
Facility Name
Diagnostic Consultative Center Aleksandrovska
City
Sofia
State/Province
Sofia (stolitsa)
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
MHAT Botevgrad
City
Botevgrad
State/Province
Sofia
ZIP/Postal Code
2140
Country
Bulgaria
Facility Name
Medical Center Zdrave 1
City
Kozloduy
State/Province
Vratsa
ZIP/Postal Code
3320
Country
Bulgaria
Facility Name
"Prevencia - 2000 - Medical Center for Prehospital Medical Care" OOD
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Dr. M.B. Jones Inc.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 4A1
Country
Canada
Facility Name
G A Research Associates
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1G 1A7
Country
Canada
Facility Name
Aggarwal and Associates Limited
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Facility Name
Dawson Clinical Research
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1H 1B1
Country
Canada
Facility Name
Milestone Research Inc.
City
London
State/Province
Ontario
ZIP/Postal Code
N5W 6A2
Country
Canada
Facility Name
Bluewater Clinical Research Group Inc.
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
LMC Clinical Research Inc. (Bayview)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
Manna Research Mirabel
City
Mirabel
State/Province
Quebec
ZIP/Postal Code
J7J 2K8
Country
Canada
Facility Name
Diex Recherche Victoriavile Inc.
City
Victoriaville
State/Province
Quebec
ZIP/Postal Code
G6P 6P6
Country
Canada
Facility Name
Diex Recherche Quebec Inc.
City
Quebec
ZIP/Postal Code
G1V 4T3
Country
Canada
Facility Name
Centre de Recherche Saint-Louis
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
MUDr. Alena Vachova
City
Ceske Budejovice
State/Province
Jihočeský KRAJ
ZIP/Postal Code
37011
Country
Czechia
Facility Name
EDUMED s.r.o.
City
Broumov
State/Province
Kralovehradecky KRAY
ZIP/Postal Code
550 01
Country
Czechia
Facility Name
Kardiologicka a Angiologicka Ambulance
City
Ostrava
State/Province
Ostrava Město
ZIP/Postal Code
700 30
Country
Czechia
Facility Name
Agentura Science Pro
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Private Practice - Dr. Tomáš Brychta
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
EUC Klinika Praha
City
Prague
ZIP/Postal Code
150 00
Country
Czechia
Facility Name
Clinical Trials Service s.r.o.
City
Uherske Hradiste
Country
Czechia
Facility Name
Belinus Orvosi és Számitástechnikai Bt
City
Debrecen
State/Province
Hajdú-bihar
ZIP/Postal Code
4025
Country
Hungary
Facility Name
Borbánya Praxis
City
Nyíregyháza, Borbánya
State/Province
Szabolcs-szatmár-bereg
ZIP/Postal Code
4405
Country
Hungary
Facility Name
CLINFAN Szolgáltató Kft
City
Szekszárd
State/Province
Tolna
ZIP/Postal Code
7100
Country
Hungary
Facility Name
DRC Gyógyszervizsgáló Központ
City
Balatonfüred
State/Province
Veszprém
ZIP/Postal Code
8230
Country
Hungary
Facility Name
ClinDiab Kft.
City
Budapest
ZIP/Postal Code
1089
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
04032
Country
Hungary
Facility Name
Nakakinen clinic
City
Naka
State/Province
Ibaraki
ZIP/Postal Code
311-0113
Country
Japan
Facility Name
Yokohama Minoru Clinic
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0064
Country
Japan
Facility Name
Shiraiwa Medical Clinic
City
Kashiwara
State/Province
Osaka
ZIP/Postal Code
582-0005
Country
Japan
Facility Name
Medical Corporation Heishinkai OCROM Clinic
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0853
Country
Japan
Facility Name
Seiwa Clinic
City
Adachi-ku
State/Province
Tokyo
ZIP/Postal Code
120-0011
Country
Japan
Facility Name
Seiwa Clinic
City
Adachi-ku
State/Province
Tokyo
ZIP/Postal Code
123-0845
Country
Japan
Facility Name
Tokyo-Eki Center-building Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Medical Corporation Chiseikai Tokyo Center Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0028
Country
Japan
Facility Name
Fukuwa Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Facility Name
Medical Corporation Heishinkai ToCROM Clinic
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0008
Country
Japan
Facility Name
Yokohama Minoru Clinic
City
Yokohama
ZIP/Postal Code
232-0064
Country
Japan
Facility Name
KO-MED Centra Kliniczne Pulawy
City
Pulawy
State/Province
Lubelskie
ZIP/Postal Code
24-100
Country
Poland
Facility Name
Oświęcimskie Centrum Badań Klinicznych
City
Oświęcim
State/Province
Małopolskie
ZIP/Postal Code
32-600
Country
Poland
Facility Name
Zdrowie Osteo-Medic
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Centrum Badan Klinicznych PI-House sp. z o.o.
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Centrum Zdrowia Metabolicznego Pawel Bogdanski
City
Poznan
ZIP/Postal Code
60-589
Country
Poland
Facility Name
Gabinet Lekarski Małgorzata Jadwiga Saryusz-Wolska
City
Łódź
ZIP/Postal Code
90-132
Country
Poland
Facility Name
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
City
Ruda Slaska
State/Province
Śląskie
ZIP/Postal Code
41-709
Country
Poland
Facility Name
Latin Clinical Trial Center
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
GCM Medical Group, PSC - Hato Rey Site
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C3991004
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Trial to Learn About the Study Medicine (PF-07081532) and Rybelsus in People With Type 2 Diabetes and Separately PF-07081532 in People With Obesity
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