Phase
Condition
Obesity
Diabetes Prevention
Diabetes And Hypertension
Treatment
Rybelsus
PF-07081532
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
Exclusion Criteria:
Any of the following: Active/current, symptomatic gallbladder disease; History ofpancreatitis in the prior 2-months;History of Type 1 Diabetes Mellitus, or secondaryforms of diabetes; Any condition affecting drug absorption; Medical history ofactive 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 glycemiccontrol;History of diabetic ketoacidosis;Proliferative retinopathy or maculopathyrequiring acute treatment;
Obesity: Previous or planned weight reduction surgery; Major depressive disorder orother severe psychiatric disorders; Any lifetime history of a suicide attempt; PHQ-9score ≥15; Response of "yes" to Question 4 or 5, or on any suicidal behavioralquestion 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 studyparticipation or, in the investigator's judgment, make the participant inappropriatefor 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 ahistory of Gilbert syndrome ; TSH >1.5x ULN or <LLN; Serum calcitonin >ULN; Serumamylase or serum lipase >ULN; eGFR <45 ml/min/1.73 ; Active Hepatitis B, orHepatitis C; A positive urine drug test for illicit drugs
Study Design
Connect with a study center
Medical Centre "Asklepiy"
Dupnitsa, Kyustendil 2600
BulgariaSite Not Available
MHAT Botevgrad
Botevgrad, Sofia 2140
BulgariaSite Not Available
Diagnostic Consultative Center Aleksandrovska
Sofia, Sofia (stolitsa) 1431
BulgariaSite Not Available
Medical Center Zdrave 1
Kozloduy, Vratsa 3320
BulgariaSite Not Available
"Prevencia - 2000 - Medical Center for Prehospital Medical Care" OOD
Stara Zagora, 6000
BulgariaSite Not Available
Dr. M.B. Jones Inc.
Victoria, British Columbia V8V 4A1
CanadaSite Not Available
G A Research Associates
Moncton, New Brunswick E1G 1A7
CanadaSite Not Available
Aggarwal and Associates Limited
Brampton, Ontario L6T 0G1
CanadaSite Not Available
Dawson Clinical Research
Guelph, Ontario N1H 1B1
CanadaSite Not Available
Milestone Research Inc.
London, Ontario N5W 6A2
CanadaSite Not Available
Bluewater Clinical Research Group Inc.
Sarnia, Ontario N7T 4X3
CanadaSite Not Available
LMC Clinical Research Inc. (Bayview)
Toronto, Ontario M4G 3E8
CanadaSite Not Available
Manna Research Mirabel
Mirabel, Quebec J7J 2K8
CanadaSite Not Available
Diex Recherche Victoriavile Inc.
Victoriaville, Quebec G6P 6P6
CanadaSite Not Available
Centre de Recherche Saint-Louis
Quebec, G1W 4R4
CanadaSite Not Available
Diex Recherche Quebec Inc.
Quebec, G1V 4T3
CanadaSite Not Available
MUDr. Alena Vachova
Ceske Budejovice, Jihočeský KRAJ 37011
CzechiaSite Not Available
EDUMED s.r.o.
Broumov, Kralovehradecky KRAY 550 01
CzechiaSite Not Available
Kardiologicka a Angiologicka Ambulance
Ostrava, Ostrava Město 700 30
CzechiaSite Not Available
Clinical Trials Service s.r.o.
Uherské Hradiště, Zlínský KRAJ 686 01
CzechiaSite Not Available
Agentura Science Pro
Olomouc, 779 00
CzechiaSite Not Available
Private Practice - Dr. Tomáš Brychta
Olomouc, 779 00
CzechiaSite Not Available
EUC Klinika Praha
Prague, 150 00
CzechiaSite Not Available
Clinical Trials Service s.r.o.
Uherske Hradiste,
CzechiaSite Not Available
Belinus Orvosi és Számitástechnikai Bt
Debrecen, Hajdú-bihar 4025
HungarySite Not Available
Borbánya Praxis
Nyíregyháza, Borbánya, Szabolcs-szatmár-bereg 4405
HungarySite Not Available
CLINFAN Szolgáltató Kft
Szekszárd, Tolna 7100
HungarySite Not Available
DRC Gyógyszervizsgáló Központ
Balatonfüred, Veszprém 8230
HungarySite Not Available
ClinDiab Kft.
Budapest, 1089
HungarySite Not Available
Debreceni Egyetem Klinikai Kozpont
Debrecen, 04032
HungarySite Not Available
Nakakinen clinic
Naka, Ibaraki 311-0113
JapanSite Not Available
Yokohama Minoru Clinic
Yokohama, Kanagawa 232-0064
JapanSite Not Available
Shiraiwa Medical Clinic
Kashiwara, Osaka 582-0005
JapanSite Not Available
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka 565-0853
JapanSite Not Available
Seiwa Clinic
Adachi-ku, Tokyo 120-0011
JapanSite Not Available
Fukuwa Clinic
Chuo-ku, Tokyo 104-0031
JapanSite Not Available
Medical Corporation Chiseikai Tokyo Center Clinic
Chuo-ku, Tokyo 103-0028
JapanSite Not Available
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo 103-0027
JapanSite Not Available
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, Tokyo 160-0008
JapanSite Not Available
KO-MED Centra Kliniczne Pulawy
Pulawy, Lubelskie 24-100
PolandSite Not Available
Ko-Med Centra Kliniczne Puławy
Pulawy, Lubelskie 24-100
PolandActive - Recruiting
Oświęcimskie Centrum Badań Klinicznych
Oświęcim, Małopolskie 32-600
PolandSite Not Available
Zdrowie Osteo-Medic
Bialystok, Podlaskie 15-351
PolandSite Not Available
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomorskie 80-546
PolandSite Not Available
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
Ruda Slaska, Śląskie 41-709
PolandSite Not Available
Centrum Zdrowia Metabolicznego Pawel Bogdanski
Poznan, 60-589
PolandSite Not Available
Gabinet Lekarski Małgorzata Jadwiga Saryusz-Wolska
Łódź, 90-132
PolandSite Not Available
GCM Medical Group, PSC - Hato Rey Site
San Juan, 00917
Puerto RicoSite Not Available
Latin Clinical Trial Center
San Juan, 00909
Puerto RicoSite Not Available
Trinity Clinical Research
Centreville, Alabama 35042
United StatesSite Not Available
Anaheim Clinical Trials, LLC
Anaheim, California 92801
United StatesSite Not Available
San Fernando Valley Health Institute
Canoga Park, California 91304
United StatesSite Not Available
Catalina Research Institute, LLC
Montclair, California 91763
United StatesSite Not Available
Empire Clinical Research
Pomona, California 91767
United StatesSite Not Available
University Clinical Investigators, Inc.
Tustin, California 92780
United StatesSite Not Available
Diablo Clinical Research, Inc.
Walnut Creek, California 94598
United StatesSite Not Available
Innovative Research of West Florida
Clearwater, Florida 33756
United StatesSite Not Available
Jacksonville Center for Clinical Research
Jacksonville, Florida 32216
United StatesSite Not Available
Adult Medicine of Lake County
Mount Dora, Florida 32757
United StatesSite Not Available
Endocrine Research Solutions, Inc.
Roswell, Georgia 30076
United StatesSite Not Available
Cedar Crosse Research Center
Chicago, Illinois 60607
United StatesSite Not Available
Evanston Premier Healthcare Research LLC
Skokie, Illinois 60077
United StatesSite Not Available
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa 50265
United StatesSite Not Available
Anderson Medical Research
Fort Washington, Maryland 20744
United StatesSite Not Available
StudyMetrix Research
Saint Peters, Missouri 63303
United StatesSite Not Available
Mercury Street Medical Group, PLLC
Butte, Montana 59701
United StatesSite Not Available
Hassman Research Institute
Berlin, New Jersey 08009
United StatesSite Not Available
Premier Research
Trenton, New Jersey 08611
United StatesSite Not Available
Medication Management
Greensboro, North Carolina 27405
United StatesSite Not Available
Meridian Clinical Research, LLC
Cincinnati, Ohio 45219
United StatesSite Not Available
Alliance for Multispecialty Research, LLC
Norman, Oklahoma 73069
United StatesSite Not Available
Heritage Valley Multispecialty Group, Inc
Beaver, Pennsylvania 15009
United StatesSite Not Available
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
Pittsburgh, Pennsylvania 15236
United StatesSite Not Available
Preferred Primary Care Physicians
Uniontown, Pennsylvania 15401
United StatesSite Not Available
Velocity Clinical Research, Providence
East Greenwich, Rhode Island 02818
United StatesSite Not Available
HealthStar Physicians, P.C.
Morristown, Tennessee 37813
United StatesSite Not Available
Healthstar Physicians
Morristown, Tennessee 37813
United StatesSite Not Available
Elligo Clinical Research Center
Austin, Texas 78738
United StatesSite Not Available
UT Southwestern Medical Center
Dallas, Texas 75390
United StatesSite Not Available
Velocity Clinical Research, Dallas
Dallas, Texas 75230
United StatesSite Not Available
Medical Colleagues of Texas, LLP
Katy, Texas 77450
United StatesSite Not Available
Tapia Internal Medicine Clinic
Paris, Texas 75462
United StatesSite Not Available
Northeast Clinical Research of San Antonio
San Antonio, Texas 78233
United StatesSite Not Available
Consano Clinical Research, LLC
Shavano Park, Texas 78231
United StatesSite Not Available
Sugar Lakes Family Practice
Sugar Land, Texas 77479
United StatesSite Not Available
Chrysalis Clinical Research
Saint George, Utah 84790
United StatesSite Not Available
Southwest Internal Medicine
Saint George, Utah 84790
United StatesSite Not Available
Manassas Clinical Research Center
Manassas, Virginia 20110
United StatesSite Not Available

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