A Master Protocol for Orforglipron (LY3502970) in Participants With Obesity or Overweight With and Without Type 2 Diabetes
Phase 3 – large-scale trial before approval
Conditions:
Obesity
Overweight
Type 2 Diabetes
Sponsor: Eli Lilly and Company
trial.available_in:
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Overview
The purpose of this Master Protocol is to support two studies to see how well and how safely orforglipron works compared to placebo in participants who have obesity or overweight with or without type 2 diabetes. Participants will be screened for about 4 weeks, after which they will enroll into either J2A-MC-GZP1, NCT06972459 (do not have type 2 diabetes) or J2A-MC-GZP2, NCT06972472 (have type 2 diabetes).
Who can participate
There are no specific eligibility criteria for the Master Protocol.
* See study GZP1 for eligibility criteria relevant to participants with obesity and overweight without type 2 diabetes
* See study GZP2 for eligibility criteria relevant to participants with type 2 diabetes
Interventions
Orforglipron
DRUG
Placebo
DRUG
Locations
80
Argentina (6)
CARE - Centro de Alergia y Enfermedades Respiratorias
Buenos Aires
CIPREC
Buenos Aires
Centro Médico Viamonte
Buenos Aires
Instituto Centenario
CABA
Instituto Médico Catamarca IMEC
Rosario
Centro de Diagnóstico y Rehabilitación (CEDIR)
Santa Fe
China (12)
Xuanwu Hospital Capital Medical University
Beijing
Peking University Third Hospital
Beijing
Sichuan Provincial People's Hospital
Chengdu
The Second Affiliated Hospital Chongqing Medical University
Chongqing
Zhujiang Hospital
Guangzhou
The Fourth Affiliated Hospital of Harbin Medical University
Harbin
The Second People's Hospital of Hefei
Hefei
Jinan Central Hospital
Jinan
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi
Zhongda Hospital Southeast University
Nanjing
The Second Affiliated Hospital of Nanjing Medical University
Nanjing
The Second Hospital of Tianjin Medical University
Tianjin
Czech Republic (5)
MUDr. Alena Vachova
České Budějovice
Nemocnice Cesky Krumlov
Český Krumlov
Donmed s.r.o.
Ostrava
Milan Kvapil s.r.o., Diabetologicka ambulance
Prague
Medical Plus
Uherské Hradiště
Germany (7)
InnoDiab Forschung Gmbh
Essen
Medizentrum Essen Borbeck
Essen
Diabetes Zentrum Wilhelmsburg
Hamburg
AmBeNet GmbH
Leipzig
Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut
Leipzig
Medicover Neuroendokrinologie
Munich
RED-Institut GmbH
Oldenburg
Japan (13)
Hasegawa Medicine Clinic
Chitose
The Institute of Medical Science, Asahi Life Foundation
Chūōku
Tokyo-Eki Center-building Clinic
Chūōku
Fukuwa Clinic
Chūōku
Tokuyama Clinic
Mihama-ku,Chiba City
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku
Medical Corporation Heishinkai OCROM Clinic
Suita-shi
Olive Takamatsu Medical Clinic
Takamatsu
Shimokitazawa Tomo Clinic
Tokyo
Tsuchiura Medical & Health Care Center
Tsuchiura
Noritake Clinic
Ushiku
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
Yamato-shi
Yokohama Minoru Clinic
Yokohama
Puerto Rico (2)
Puerto Rico Health and Wellness Institute
Dorado
Isis Clinical Research Center
Guaynabo
United States (35)
Great Lakes Research Group, Inc.
Bay City , Michigan
Javara - Nevada Health Centers - Carson City
Carson City , Nevada
University of North Carolina Medical Center
Chapel Hill , North Carolina
Javara - Tryon Medical Partners
Charlotte , North Carolina
The Corvallis Clinic, P.C.
Corvallis , Oregon
Velocity Clinical Research, Dallas
Dallas , Texas
Accel Research Sites - NeuroStudies Clinical Research Unit
Decatur , Georgia
Care Access - Decatur
Decatur , Georgia
Accel Research Sites - DeLand Clinical Research Unit
DeLand , Florida
Care Access - Fayetteville
Fayetteville , North Carolina
Innovation Medical Research Center - Fort Lauderdale
Fort Lauderdale , Florida
Indago Research & Health Center, Inc
Hialeah , Florida
Encore Medical Research
Hollywood , Florida
Biopharma Informatic, LLC
Houston , Texas
Activian Clinical Research
Kingwood , Texas
The Machuca Foundation
Las Vegas , Nevada
Solaris Clinical Research
Meridian , Idaho
Texas Valley Clinical Research (TVCR) - Mission
Mission , Texas
Boeson Research MSO
Missoula , Montana
Care Access - New Iberia
New Iberia , Louisiana
West Orange Endocrinology P.A.
Ocoee , Florida
Clinical Research of Philadelphia
Philadelphia , Pennsylvania
Endocrine and Metabolic Consultants
Rockville , Maryland
Norcal Endocrinology & Internal Medicine
San Ramon , California
Southern California Clinical Research
Santa Ana , California
Javara - Privia Medical Group Georgia - Savannah
Savannah , Georgia
Consano Clinical Research, LLC
Shavano Park , Texas
Javara - Privia Medical Group - Silver Spring
Silver Spring , Maryland
Frontier Clinical Research, LLC
Smithfield , Pennsylvania
Clinical Research Institute of Arizona (CRI) - Sun City West
Sun City West , Arizona
Care Access - Tampa
Tampa , Florida
Care Access - Thousand Oaks
Thousand Oaks , California
Novak Clinical Research - Tucson - North La Cholla Boulevard
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