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
Diabetes Mellitus, Obesity
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
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
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
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