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

Last updated: July 9, 2024
Sponsor: Pfizer
Overall Status: Terminated

Phase

2

Condition

Obesity

Diabetes Prevention

Diabetes And Hypertension

Treatment

Rybelsus

PF-07081532

Placebo

Clinical Study ID

NCT05579977
C3991004
2022-002834-15
  • Ages 18-75
  • All Genders

Study 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.

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

Total Participants: 902
Treatment Group(s): 3
Primary Treatment: Rybelsus
Phase: 2
Study Start date:
October 27, 2022
Estimated Completion Date:
September 22, 2023

Connect with a study center

  • Medical Centre "Asklepiy"

    Dupnitsa, Kyustendil 2600
    Bulgaria

    Site Not Available

  • MHAT Botevgrad

    Botevgrad, Sofia 2140
    Bulgaria

    Site Not Available

  • Diagnostic Consultative Center Aleksandrovska

    Sofia, Sofia (stolitsa) 1431
    Bulgaria

    Site Not Available

  • Medical Center Zdrave 1

    Kozloduy, Vratsa 3320
    Bulgaria

    Site Not Available

  • "Prevencia - 2000 - Medical Center for Prehospital Medical Care" OOD

    Stara Zagora, 6000
    Bulgaria

    Site Not Available

  • Dr. M.B. Jones Inc.

    Victoria, British Columbia V8V 4A1
    Canada

    Site Not Available

  • G A Research Associates

    Moncton, New Brunswick E1G 1A7
    Canada

    Site Not Available

  • Aggarwal and Associates Limited

    Brampton, Ontario L6T 0G1
    Canada

    Site Not Available

  • Dawson Clinical Research

    Guelph, Ontario N1H 1B1
    Canada

    Site Not Available

  • Milestone Research Inc.

    London, Ontario N5W 6A2
    Canada

    Site Not Available

  • Bluewater Clinical Research Group Inc.

    Sarnia, Ontario N7T 4X3
    Canada

    Site Not Available

  • LMC Clinical Research Inc. (Bayview)

    Toronto, Ontario M4G 3E8
    Canada

    Site Not Available

  • Manna Research Mirabel

    Mirabel, Quebec J7J 2K8
    Canada

    Site Not Available

  • Diex Recherche Victoriavile Inc.

    Victoriaville, Quebec G6P 6P6
    Canada

    Site Not Available

  • Centre de Recherche Saint-Louis

    Quebec, G1W 4R4
    Canada

    Site Not Available

  • Diex Recherche Quebec Inc.

    Quebec, G1V 4T3
    Canada

    Site Not Available

  • MUDr. Alena Vachova

    Ceske Budejovice, Jihočeský KRAJ 37011
    Czechia

    Site Not Available

  • EDUMED s.r.o.

    Broumov, Kralovehradecky KRAY 550 01
    Czechia

    Site Not Available

  • Kardiologicka a Angiologicka Ambulance

    Ostrava, Ostrava Město 700 30
    Czechia

    Site Not Available

  • Clinical Trials Service s.r.o.

    Uherské Hradiště, Zlínský KRAJ 686 01
    Czechia

    Site Not Available

  • Agentura Science Pro

    Olomouc, 779 00
    Czechia

    Site Not Available

  • Private Practice - Dr. Tomáš Brychta

    Olomouc, 779 00
    Czechia

    Site Not Available

  • EUC Klinika Praha

    Prague, 150 00
    Czechia

    Site Not Available

  • Clinical Trials Service s.r.o.

    Uherske Hradiste,
    Czechia

    Site Not Available

  • Belinus Orvosi és Számitástechnikai Bt

    Debrecen, Hajdú-bihar 4025
    Hungary

    Site Not Available

  • Borbánya Praxis

    Nyíregyháza, Borbánya, Szabolcs-szatmár-bereg 4405
    Hungary

    Site Not Available

  • CLINFAN Szolgáltató Kft

    Szekszárd, Tolna 7100
    Hungary

    Site Not Available

  • DRC Gyógyszervizsgáló Központ

    Balatonfüred, Veszprém 8230
    Hungary

    Site Not Available

  • ClinDiab Kft.

    Budapest, 1089
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 04032
    Hungary

    Site Not Available

  • Nakakinen clinic

    Naka, Ibaraki 311-0113
    Japan

    Site Not Available

  • Yokohama Minoru Clinic

    Yokohama, Kanagawa 232-0064
    Japan

    Site Not Available

  • Shiraiwa Medical Clinic

    Kashiwara, Osaka 582-0005
    Japan

    Site Not Available

  • Medical Corporation Heishinkai OCROM Clinic

    Suita-shi, Osaka 565-0853
    Japan

    Site Not Available

  • Seiwa Clinic

    Adachi-ku, Tokyo 120-0011
    Japan

    Site Not Available

  • Fukuwa Clinic

    Chuo-ku, Tokyo 104-0031
    Japan

    Site Not Available

  • Medical Corporation Chiseikai Tokyo Center Clinic

    Chuo-ku, Tokyo 103-0028
    Japan

    Site Not Available

  • Tokyo-Eki Center-building Clinic

    Chuo-ku, Tokyo 103-0027
    Japan

    Site Not Available

  • Medical Corporation Heishinkai ToCROM Clinic

    Shinjuku-ku, Tokyo 160-0008
    Japan

    Site Not Available

  • KO-MED Centra Kliniczne Pulawy

    Pulawy, Lubelskie 24-100
    Poland

    Site Not Available

  • Ko-Med Centra Kliniczne Puławy

    Pulawy, Lubelskie 24-100
    Poland

    Active - Recruiting

  • Oświęcimskie Centrum Badań Klinicznych

    Oświęcim, Małopolskie 32-600
    Poland

    Site Not Available

  • Zdrowie Osteo-Medic

    Bialystok, Podlaskie 15-351
    Poland

    Site Not Available

  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk, Pomorskie 80-546
    Poland

    Site Not Available

  • NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki

    Ruda Slaska, Śląskie 41-709
    Poland

    Site Not Available

  • Centrum Zdrowia Metabolicznego Pawel Bogdanski

    Poznan, 60-589
    Poland

    Site Not Available

  • Gabinet Lekarski Małgorzata Jadwiga Saryusz-Wolska

    Łódź, 90-132
    Poland

    Site Not Available

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, 00917
    Puerto Rico

    Site Not Available

  • Latin Clinical Trial Center

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • Trinity Clinical Research

    Centreville, Alabama 35042
    United States

    Site Not Available

  • Anaheim Clinical Trials, LLC

    Anaheim, California 92801
    United States

    Site Not Available

  • San Fernando Valley Health Institute

    Canoga Park, California 91304
    United States

    Site Not Available

  • Catalina Research Institute, LLC

    Montclair, California 91763
    United States

    Site Not Available

  • Empire Clinical Research

    Pomona, California 91767
    United States

    Site Not Available

  • University Clinical Investigators, Inc.

    Tustin, California 92780
    United States

    Site Not Available

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Innovative Research of West Florida

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Adult Medicine of Lake County

    Mount Dora, Florida 32757
    United States

    Site Not Available

  • Endocrine Research Solutions, Inc.

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Cedar Crosse Research Center

    Chicago, Illinois 60607
    United States

    Site Not Available

  • Evanston Premier Healthcare Research LLC

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa 50265
    United States

    Site Not Available

  • Anderson Medical Research

    Fort Washington, Maryland 20744
    United States

    Site Not Available

  • StudyMetrix Research

    Saint Peters, Missouri 63303
    United States

    Site Not Available

  • Mercury Street Medical Group, PLLC

    Butte, Montana 59701
    United States

    Site Not Available

  • Hassman Research Institute

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Premier Research

    Trenton, New Jersey 08611
    United States

    Site Not Available

  • Medication Management

    Greensboro, North Carolina 27405
    United States

    Site Not Available

  • Meridian Clinical Research, LLC

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Heritage Valley Multispecialty Group, Inc

    Beaver, Pennsylvania 15009
    United States

    Site Not Available

  • Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)

    Pittsburgh, Pennsylvania 15236
    United States

    Site Not Available

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania 15401
    United States

    Site Not Available

  • Velocity Clinical Research, Providence

    East Greenwich, Rhode Island 02818
    United States

    Site Not Available

  • HealthStar Physicians, P.C.

    Morristown, Tennessee 37813
    United States

    Site Not Available

  • Healthstar Physicians

    Morristown, Tennessee 37813
    United States

    Site Not Available

  • Elligo Clinical Research Center

    Austin, Texas 78738
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Velocity Clinical Research, Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • Medical Colleagues of Texas, LLP

    Katy, Texas 77450
    United States

    Site Not Available

  • Tapia Internal Medicine Clinic

    Paris, Texas 75462
    United States

    Site Not Available

  • Northeast Clinical Research of San Antonio

    San Antonio, Texas 78233
    United States

    Site Not Available

  • Consano Clinical Research, LLC

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • Sugar Lakes Family Practice

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Chrysalis Clinical Research

    Saint George, Utah 84790
    United States

    Site Not Available

  • Southwest Internal Medicine

    Saint George, Utah 84790
    United States

    Site Not Available

  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.