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 (75) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The main purpose of this study is to see how orforglipron, compared with placebo, helps reduce body weight in participants with obesity or with overweight and at least one other related health condition (excluding type 2 diabetes). This trial is part of the master protocol study J2A-MC-GZPO (NCT06993792). Participation in the study will last about 18 months.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Have body mass index (BMI) ≥30 kilograms per square meter (kg/m2) or BMI ≥25.0 kg/m2 and at least 1 of the following weight-related comorbidities at screening:
‣ hypertension
⁃ dyslipidemia
⁃ obstructive sleep apnea, or
⁃ cardiovascular disease
• Have a history of at least one unsuccessful dietary effort to lose body weight
Locations
United States
Arizona
Clinical Research Institute of Arizona (CRI) - Sun City West
ACTIVE_NOT_RECRUITING
Sun City West
Novak Clinical Research - Tucson - North La Cholla Boulevard
ACTIVE_NOT_RECRUITING
Tucson
California
Norcal Endocrinology & Internal Medicine
ACTIVE_NOT_RECRUITING
San Ramon
Southern California Clinical Research
ACTIVE_NOT_RECRUITING
Santa Ana
Care Access - Thousand Oaks
ACTIVE_NOT_RECRUITING
Thousand Oaks
Florida
Accel Research Sites - DeLand Clinical Research Unit
ACTIVE_NOT_RECRUITING
Deland
Innovation Medical Research Center - Fort Lauderdale
ACTIVE_NOT_RECRUITING
Fort Lauderdale
Indago Research & Health Center, Inc
ACTIVE_NOT_RECRUITING
Hialeah
Encore Medical Research
ACTIVE_NOT_RECRUITING
Hollywood
West Orange Endocrinology P.A.
ACTIVE_NOT_RECRUITING
Ocoee
Care Access - Tampa
ACTIVE_NOT_RECRUITING
Tampa
Conquest Research
ACTIVE_NOT_RECRUITING
Winter Park
Georgia
Accel Research Sites - NeuroStudies Clinical Research Unit
ACTIVE_NOT_RECRUITING
Decatur
Care Access - Decatur
ACTIVE_NOT_RECRUITING
Decatur
Javara - Privia Medical Group Georgia - Savannah
ACTIVE_NOT_RECRUITING
Savannah
North Georgia Clinical Research
ACTIVE_NOT_RECRUITING
Woodstock
Idaho
Solaris Clinical Research
ACTIVE_NOT_RECRUITING
Meridian
Louisiana
Care Access - New Iberia
ACTIVE_NOT_RECRUITING
New Iberia
Maryland
Endocrine and Metabolic Consultants
ACTIVE_NOT_RECRUITING
Rockville
Javara - Privia Medical Group - Silver Spring
ACTIVE_NOT_RECRUITING
Silver Spring
Michigan
Great Lakes Research Group, Inc.
ACTIVE_NOT_RECRUITING
Bay City
Montana
Boeson Research MSO
ACTIVE_NOT_RECRUITING
Missoula
North Carolina
University of North Carolina Medical Center
ACTIVE_NOT_RECRUITING
Chapel Hill
Javara - Tryon Medical Partners
ACTIVE_NOT_RECRUITING
Charlotte
Care Access - Fayetteville
ACTIVE_NOT_RECRUITING
Fayetteville
Nevada
Javara - Nevada Health Centers - Carson City
ACTIVE_NOT_RECRUITING
Carson City
The Machuca Foundation
ACTIVE_NOT_RECRUITING
Las Vegas
Oregon
The Corvallis Clinic, P.C.
ACTIVE_NOT_RECRUITING
Corvallis
Pennsylvania
Clinical Research of Philadelphia
ACTIVE_NOT_RECRUITING
Philadelphia
Frontier Clinical Research, LLC
ACTIVE_NOT_RECRUITING
Smithfield
Texas
Velocity Clinical Research, Dallas
ACTIVE_NOT_RECRUITING
Dallas
Biopharma Informatic, LLC
ACTIVE_NOT_RECRUITING
Houston
Activian Clinical Research
ACTIVE_NOT_RECRUITING
Kingwood
Texas Valley Clinical Research (TVCR) - Mission
ACTIVE_NOT_RECRUITING
Mission
Consano Clinical Research, LLC
ACTIVE_NOT_RECRUITING
Shavano Park
Other Locations
Argentina
CARE - Centro de Alergia y Enfermedades Respiratorias
ACTIVE_NOT_RECRUITING
Buenos Aires
Centro Médico Viamonte
ACTIVE_NOT_RECRUITING
Buenos Aires
CIPREC
ACTIVE_NOT_RECRUITING
Buenos Aires
Instituto Centenario
ACTIVE_NOT_RECRUITING
Caba
Instituto Médico Catamarca IMEC
ACTIVE_NOT_RECRUITING
Rosario
Centro de Diagnóstico y Rehabilitación (CEDIR)
ACTIVE_NOT_RECRUITING
Santa Fe
China
Peking University Third Hospital
COMPLETED
Beijing
Xuanwu Hospital Capital Medical University
ACTIVE_NOT_RECRUITING
Beijing
Sichuan Provincial People's Hospital
ACTIVE_NOT_RECRUITING
Chengdu
The Second Affiliated Hospital Chongqing Medical University
ACTIVE_NOT_RECRUITING
Chongqing
Zhujiang Hospital
ACTIVE_NOT_RECRUITING
Guangzhou
The Fourth Affiliated Hospital of Harbin Medical University
ACTIVE_NOT_RECRUITING
Harbin
The Second People's Hospital of Hefei
ACTIVE_NOT_RECRUITING
Hefei
Jinan Central Hospital
ACTIVE_NOT_RECRUITING
Jinan
The First Affiliated Hospital of Henan University of Science &Technology
ACTIVE_NOT_RECRUITING
Luoyang Shi
The Second Affiliated Hospital of Nanjing Medical University
ACTIVE_NOT_RECRUITING
Nanjing
Zhongda Hospital Southeast University
ACTIVE_NOT_RECRUITING
Nanjing
The Second Hospital of Tianjin Medical University
ACTIVE_NOT_RECRUITING
Tianjin
Germany
InnoDiab Forschung Gmbh
ACTIVE_NOT_RECRUITING
Essen
Medizentrum Essen Borbeck
ACTIVE_NOT_RECRUITING
Essen
Diabetes Zentrum Wilhelmsburg
ACTIVE_NOT_RECRUITING
Hamburg
AmBeNet GmbH
ACTIVE_NOT_RECRUITING
Leipzig
Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut
ACTIVE_NOT_RECRUITING
Leipzig
Medicover Neuroendokrinologie
ACTIVE_NOT_RECRUITING
Munich
RED-Institut GmbH
ACTIVE_NOT_RECRUITING
Oldenburg
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
Puerto Rico
Puerto Rico Health and Wellness Institute
ACTIVE_NOT_RECRUITING
Dorado
Isis Clinical Research Center
ACTIVE_NOT_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: 600
Treatments
Experimental: Orforglipron Dose 1
Participants will receive orforglipron orally
Experimental: Orforglipron Dose 2
Participants will receive orforglipron orally
Experimental: Orforglipron Dose 3
Participants will receive orforglipron orally
Experimental: Orforglipron Dose 4
Participants will receive orforglipron orally
Placebo_comparator: Placebo
Participants will receive placebo orally
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company