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A Master Protocol for Orforglipron (LY3502970) in Participants With Obesity or Overweight With and Without Type 2 Diabetes
NCT06993792 · Eli Lilly and Company
In plain English
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Official title
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
About this study
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 criteria
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
Study design
Enrollment target: 1200 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-05-15
Estimated completion: 2027-08
Last updated: 2026-04-16
Interventions
Drug: OrforglipronDrug: Placebo
Primary outcomes
- • Number of Participants Allocated to Each Study (Baseline to Week 4)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · study_director, Eli Lilly and Company
All locations (80)
Clinical Research Institute of Arizona (CRI) - Sun City WestRecruiting
Sun City West, Arizona, United States
Novak Clinical Research - Tucson - North La Cholla BoulevardRecruiting
Tucson, Arizona, United States
Norcal Endocrinology & Internal MedicineRecruiting
San Ramon, California, United States
Southern California Clinical ResearchRecruiting
Santa Ana, California, United States
Care Access - Thousand OaksRecruiting
Thousand Oaks, California, United States
Accel Research Sites - DeLand Clinical Research UnitRecruiting
DeLand, Florida, United States
Innovation Medical Research Center - Fort LauderdaleRecruiting
Fort Lauderdale, Florida, United States
Indago Research & Health Center, IncRecruiting
Hialeah, Florida, United States
Encore Medical ResearchRecruiting
Hollywood, Florida, United States
West Orange Endocrinology P.A.Recruiting
Ocoee, Florida, United States
Care Access - TampaRecruiting
Tampa, Florida, United States
Conquest ResearchRecruiting
Winter Park, Florida, United States
Accel Research Sites - NeuroStudies Clinical Research UnitRecruiting
Decatur, Georgia, United States
Care Access - DecaturRecruiting
Decatur, Georgia, United States
Javara - Privia Medical Group Georgia - SavannahRecruiting
Savannah, Georgia, United States
North Georgia Clinical ResearchRecruiting
Woodstock, Georgia, United States
Solaris Clinical ResearchRecruiting
Meridian, Idaho, United States
Care Access - New IberiaRecruiting
New Iberia, Louisiana, United States
Endocrine and Metabolic ConsultantsRecruiting
Rockville, Maryland, United States
Javara - Privia Medical Group - Silver SpringRecruiting
Silver Spring, Maryland, United States
Great Lakes Research Group, Inc.Recruiting
Bay City, Michigan, United States
Boeson Research MSORecruiting
Missoula, Montana, United States
Javara - Nevada Health Centers - Carson CityRecruiting
Carson City, Nevada, United States
The Machuca FoundationRecruiting
Las Vegas, Nevada, United States
University of North Carolina Medical CenterRecruiting
Chapel Hill, North Carolina, United States
Javara - Tryon Medical PartnersRecruiting
Charlotte, North Carolina, United States
Care Access - FayettevilleRecruiting
Fayetteville, North Carolina, United States
The Corvallis Clinic, P.C.Recruiting
Corvallis, Oregon, United States
Clinical Research of PhiladelphiaRecruiting
Philadelphia, Pennsylvania, United States
Frontier Clinical Research, LLCRecruiting
Smithfield, Pennsylvania, United States
Velocity Clinical Research, DallasRecruiting
Dallas, Texas, United States
Biopharma Informatic, LLCRecruiting
Houston, Texas, United States
Activian Clinical ResearchRecruiting
Kingwood, Texas, United States
Texas Valley Clinical Research (TVCR) - MissionRecruiting
Mission, Texas, United States
Consano Clinical Research, LLCRecruiting
Shavano Park, Texas, United States
CARE - Centro de Alergia y Enfermedades RespiratoriasRecruiting
Buenos Aires, Argentina
CIPRECRecruiting
Buenos Aires, Argentina
Centro Médico ViamonteRecruiting
Buenos Aires, Argentina
Instituto CentenarioRecruiting
CABA, Argentina
Instituto Médico Catamarca IMECRecruiting
Rosario, Argentina
Centro de Diagnóstico y Rehabilitación (CEDIR)Recruiting
Santa Fe, Argentina
Xuanwu Hospital Capital Medical UniversityActive Not Recruiting
Beijing, China
Peking University Third HospitalActive Not Recruiting
Beijing, China
Sichuan Provincial People's HospitalActive Not Recruiting
Chengdu, China
The Second Affiliated Hospital Chongqing Medical UniversityActive Not Recruiting
Chongqing, China
Zhujiang HospitalActive Not Recruiting
Guangzhou, China
The Fourth Affiliated Hospital of Harbin Medical UniversityActive Not Recruiting
Harbin, China
The Second People's Hospital of HefeiActive Not Recruiting
Hefei, China
Jinan Central HospitalActive Not Recruiting
Jinan, China
The First Affiliated Hospital of Henan University of Science &TechnologyActive Not Recruiting
Luoyang Shi, China
Zhongda Hospital Southeast UniversityActive Not Recruiting
Nanjing, China
The Second Affiliated Hospital of Nanjing Medical UniversityActive Not Recruiting
Nanjing, China
The Second Hospital of Tianjin Medical UniversityActive Not Recruiting
Tianjin, China
MUDr. Alena VachovaActive Not Recruiting
České Budějovice, Czechia
Nemocnice Cesky KrumlovActive Not Recruiting
Český Krumlov, Czechia
Donmed s.r.o.Active Not Recruiting
Ostrava, Czechia
Milan Kvapil s.r.o., Diabetologicka ambulanceActive Not Recruiting
Prague, Czechia
Medical PlusActive Not Recruiting
Uherské Hradiště, Czechia
InnoDiab Forschung GmbhActive Not Recruiting
Essen, Germany
Medizentrum Essen BorbeckActive Not Recruiting
Essen, Germany
Diabetes Zentrum WilhelmsburgActive Not Recruiting
Hamburg, Germany
AmBeNet GmbHActive Not Recruiting
Leipzig, Germany
Gemeinschaftspraxis Dr. Taeschner/Dr. BonigutActive Not Recruiting
Leipzig, Germany
Medicover NeuroendokrinologieActive Not Recruiting
Munich, Germany
RED-Institut GmbHActive Not Recruiting
Oldenburg, Germany
Hasegawa Medicine ClinicRecruiting
Chitose, Japan
The Institute of Medical Science, Asahi Life FoundationRecruiting
Chūōku, Japan
Tokyo-Eki Center-building ClinicRecruiting
Chūōku, Japan
Fukuwa ClinicRecruiting
Chūōku, Japan
Tokuyama ClinicRecruiting
Mihama-ku,Chiba City, Japan
Medical Corporation Heishinkai ToCROM ClinicRecruiting
Shinjuku-ku, Japan
Medical Corporation Heishinkai OCROM ClinicRecruiting
Suita-shi, Japan
Olive Takamatsu Medical ClinicRecruiting
Takamatsu, Japan
Shimokitazawa Tomo ClinicRecruiting
Tokyo, Japan
Tsuchiura Medical & Health Care CenterRecruiting
Tsuchiura, Japan
Noritake ClinicRecruiting
Ushiku, Japan
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes ClinicRecruiting
Yamato-shi, Japan
Yokohama Minoru ClinicRecruiting
Yokohama, Japan
Puerto Rico Health and Wellness InstituteRecruiting
Dorado, Puerto Rico
Isis Clinical Research CenterRecruiting
Guaynabo, Puerto Rico