A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared With Placebo in Participants With Obesity or Overweight With and Without Type 2 Diabetes
Status: Recruiting
Location: See all (83) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ 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
Locations
United States
Arizona
Novak Clinical Research - Tucson - North La Cholla Boulevard
RECRUITING
Tucson
California
Norcal Endocrinology & Internal Medicine
RECRUITING
San Ramon
Southern California Clinical Research
RECRUITING
Santa Ana
Care Access - Thousand Oaks
RECRUITING
Thousand Oaks
Florida
Accel Research Sites - DeLand Clinical Research Unit
RECRUITING
Deland
Innovation Medical Research Center - Fort Lauderdale
RECRUITING
Fort Lauderdale
Encore Medical Research
RECRUITING
Hollywood
West Orange Endocrinology P.A.
RECRUITING
Ocoee
Care Access - Tampa
RECRUITING
Tampa
Georgia
Accel Research Sites - NeuroStudies Clinical Research Unit
RECRUITING
Decatur
Care Access - Decatur
RECRUITING
Decatur
Javara - Privia Medical Group Georgia - Savannah
RECRUITING
Savannah
North Georgia Clinical Research
RECRUITING
Woodstock
Idaho
Solaris Clinical Research
RECRUITING
Meridian
Louisiana
Care Access - New Iberia
RECRUITING
New Iberia
Maryland
Endocrine and Metabolic Consultants
RECRUITING
Rockville
Javara - Privia Medical Group - Silver Spring
RECRUITING
Silver Spring
Montana
Boeson Research MSO
RECRUITING
Missoula
North Carolina
University of North Carolina Medical Center
RECRUITING
Chapel Hill
Javara - Tryon Medical Partners
RECRUITING
Charlotte
Care Access - Fayetteville
RECRUITING
Fayetteville
Nevada
Javara - Nevada Health Centers - Carson City
RECRUITING
Carson City
The Machuca Foundation
RECRUITING
Las Vegas
Oregon
The Corvallis Clinic, P.C.
RECRUITING
Corvallis
Pennsylvania
Clinical Research of Philadelphia
RECRUITING
Philadelphia
Frontier Clinical Research, LLC
RECRUITING
Smithfield
Texas
Velocity Clinical Research, Dallas
RECRUITING
Dallas
Biopharma Informatic, LLC
RECRUITING
Houston
Texas Valley Clinical Research (TVCR) - Mission
RECRUITING
Mission
Consano Clinical Research, LLC
RECRUITING
Shavano Park
Other Locations
Argentina
CARE - Centro de Alergia y Enfermedades Respiratorias
RECRUITING
Buenos Aires
Centro Médico Viamonte
RECRUITING
Buenos Aires
CIPREC
RECRUITING
Buenos Aires
Instituto Centenario
RECRUITING
Caba
Instituto Médico Catamarca IMEC
RECRUITING
Rosario
Centro de Diagnóstico y Rehabilitación (CEDIR)
RECRUITING
Santa Fe
China
Peking University Third Hospital
RECRUITING
Beijing
Xuanwu Hospital Capital Medical University
RECRUITING
Beijing
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
The Second Affiliated Hospital Chongqing Medical University
RECRUITING
Chongqing
Zhujiang Hospital
RECRUITING
Guangzhou
The Fourth Affiliated Hospital of Harbin Medical University
RECRUITING
Harbin
The Second People's Hospital of Hefei
RECRUITING
Hefei
Jinan Central Hospital
RECRUITING
Jinan
The First Affiliated Hospital of Henan University of Science &Technology
RECRUITING
Luoyang Shi
The Second Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Zhongda Hospital Southeast University
RECRUITING
Nanjing
The Second Hospital of Tianjin Medical University
RECRUITING
Tianjin
Germany
InnoDiab Forschung Gmbh
RECRUITING
Essen
Medizentrum Essen Borbeck
RECRUITING
Essen
Diabetes Zentrum Wilhelmsburg
RECRUITING
Hamburg
AmBeNet GmbH
RECRUITING
Leipzig
Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut
RECRUITING
Leipzig
Medicover Neuroendokrinologie
RECRUITING
Munich
RED-Institut GmbH
RECRUITING
Oldenburg
India
All India Institute of Medical Sciences
NOT_YET_RECRUITING
Bhubaneswar
Apollo Excelcare Hospital
NOT_YET_RECRUITING
Guwahati
Karnataka Institute of Medical Sciences
NOT_YET_RECRUITING
Hubli
Diabetes Research Center
NOT_YET_RECRUITING
Hyderabad
Sir Ganga Ram Hospital
NOT_YET_RECRUITING
New Delhi
Chellaram Diabetes Institute
NOT_YET_RECRUITING
Pune
All India Institute of Medical Sciences - Rishikesh
NOT_YET_RECRUITING
Rishikesh
Japan
Hasegawa Medicine Clinic
RECRUITING
Chitose
Fukuwa Clinic
RECRUITING
Chūōku
The Institute of Medical Science, Asahi Life Foundation
RECRUITING
Chūōku
Tokyo-Eki Center-building Clinic
RECRUITING
Chūōku
Tokuyama Clinic
RECRUITING
Mihama-ku,chiba City
Medical Corporation Heishinkai ToCROM Clinic
RECRUITING
Shinjuku-ku
Medical Corporation Heishinkai OCROM Clinic
RECRUITING
Suita-shi
Olive Takamatsu Medical Clinic
RECRUITING
Takamatsu
Shimokitazawa Tomo Clinic
RECRUITING
Tokyo
Tsuchiura Medical & Health Care Center
RECRUITING
Tsuchiura
Noritake Clinic
RECRUITING
Ushiku
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
RECRUITING
Yamato-shi
Yokohama Minoru Clinic
RECRUITING
Yokohama
Mexico
Enclifar Ensayos Clínicos Farmacológicos Sc
NOT_YET_RECRUITING
Chihuahua City
Diseno y Planeacion en Investigacion Medica - Guadalajara - Calle Amado Nervo
NOT_YET_RECRUITING
Guadalajara
Kohler & Milstein Research S.A. De C.V.
NOT_YET_RECRUITING
Mérida
Medical Care and Research SA de CV
NOT_YET_RECRUITING
Mérida
RM Pharma Specialists - Unidad Especializada en Datos
NOT_YET_RECRUITING
Mexico City
Centro Medico Zambrano Hellion
NOT_YET_RECRUITING
San Pedro Garza García
Puerto Rico
Puerto Rico Health and Wellness Institute
RECRUITING
Dorado
Isis Clinical Research Center
RECRUITING
Guaynabo
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2025-05-15
Estimated Completion Date: 2027-08
Participants
Target number of participants: 1200
Treatments
Experimental: Orforglipron Dose 1 (Study GZP1)
Participants will receive orforglipron orally
Experimental: Orforglipron Dose 2 (Study GZP1)
Participants will receive orforglipron orally
Experimental: Orforglipron Dose 3 (Study GZP1)
Participants will receive orforglipron orally
Experimental: Orforglipron Dose 4 (Study GZP1)
Participants will receive orforglipron orally
Placebo_comparator: Placebo (Study GZP1)
Participants will receive placebo orally
Experimental: Orforglipron Dose 1 (Study GZP2)
Participants will receive orforglipron orally
Experimental: Orforglipron Dose 2 (Study GZP2)
Participants will receive orforglipron orally
Experimental: Orforglipron Dose 3 (Study GZP2)
Participants will receive orforglipron orally
Experimental: Orforglipron Dose 4 (Study GZP2)
Participants will receive orforglipron orally
Placebo_comparator: Placebo (Study GZP2)
Participants will receive placebo orally
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company