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A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity
NCT06972459 · Eli Lilly and Company
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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 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 criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* Have type 1 diabetes, type 2 diabetes, or any other types of diabetes
* Have an unstable body weight within 90 days prior to screening
* Have New York Heart Association functional classification IV congestive heart failure or an acute cardiovascular condition within 90 days prior to screening
* Have acute or chronic hepatitis or pancreatitis
* Are taking other medications or alternative remedies to manage weight loss
Study design
Enrollment target: 600 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
- • Percent Change from Baseline in Body Weight (Baseline, Week 72)
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 WestActive Not Recruiting
Sun City West, Arizona, United States
Novak Clinical Research - Tucson - North La Cholla BoulevardActive Not Recruiting
Tucson, Arizona, United States
Norcal Endocrinology & Internal MedicineActive Not Recruiting
San Ramon, California, United States
Southern California Clinical ResearchActive Not Recruiting
Santa Ana, California, United States
Care Access - Thousand OaksActive Not Recruiting
Thousand Oaks, California, United States
Accel Research Sites - DeLand Clinical Research UnitActive Not Recruiting
DeLand, Florida, United States
Innovation Medical Research Center - Fort LauderdaleActive Not Recruiting
Fort Lauderdale, Florida, United States
Indago Research & Health Center, IncActive Not Recruiting
Hialeah, Florida, United States
Encore Medical ResearchActive Not Recruiting
Hollywood, Florida, United States
West Orange Endocrinology P.A.Active Not Recruiting
Ocoee, Florida, United States
Care Access - TampaActive Not Recruiting
Tampa, Florida, United States
Conquest ResearchActive Not Recruiting
Winter Park, Florida, United States
Accel Research Sites - NeuroStudies Clinical Research UnitActive Not Recruiting
Decatur, Georgia, United States
Care Access - DecaturActive Not Recruiting
Decatur, Georgia, United States
Javara - Privia Medical Group Georgia - SavannahActive Not Recruiting
Savannah, Georgia, United States
North Georgia Clinical ResearchActive Not Recruiting
Woodstock, Georgia, United States
Solaris Clinical ResearchActive Not Recruiting
Meridian, Idaho, United States
Care Access - New IberiaActive Not Recruiting
New Iberia, Louisiana, United States
Endocrine and Metabolic ConsultantsActive Not Recruiting
Rockville, Maryland, United States
Javara - Privia Medical Group - Silver SpringActive Not Recruiting
Silver Spring, Maryland, United States
Great Lakes Research Group, Inc.Active Not Recruiting
Bay City, Michigan, United States
Boeson Research MSOActive Not Recruiting
Missoula, Montana, United States
Javara - Nevada Health Centers - Carson CityActive Not Recruiting
Carson City, Nevada, United States
The Machuca FoundationActive Not Recruiting
Las Vegas, Nevada, United States
University of North Carolina Medical CenterActive Not Recruiting
Chapel Hill, North Carolina, United States
Javara - Tryon Medical PartnersActive Not Recruiting
Charlotte, North Carolina, United States
Care Access - FayettevilleActive Not Recruiting
Fayetteville, North Carolina, United States
The Corvallis Clinic, P.C.Active Not Recruiting
Corvallis, Oregon, United States
Clinical Research of PhiladelphiaActive Not Recruiting
Philadelphia, Pennsylvania, United States
Frontier Clinical Research, LLCActive Not Recruiting
Smithfield, Pennsylvania, United States
Velocity Clinical Research, DallasActive Not Recruiting
Dallas, Texas, United States
Biopharma Informatic, LLCActive Not Recruiting
Houston, Texas, United States
Activian Clinical ResearchActive Not Recruiting
Kingwood, Texas, United States
Texas Valley Clinical Research (TVCR) - MissionActive Not Recruiting
Mission, Texas, United States
Consano Clinical Research, LLCActive Not Recruiting
Shavano Park, Texas, United States
CARE - Centro de Alergia y Enfermedades RespiratoriasActive Not Recruiting
Buenos Aires, Argentina
CIPRECActive Not Recruiting
Buenos Aires, Argentina
Centro Médico ViamonteActive Not Recruiting
Buenos Aires, Argentina
Instituto CentenarioActive Not Recruiting
CABA, Argentina
Instituto Médico Catamarca IMECActive Not Recruiting
Rosario, Argentina
Centro de Diagnóstico y Rehabilitación (CEDIR)Active Not Recruiting
Santa Fe, Argentina
Xuanwu Hospital Capital Medical UniversityActive Not Recruiting
Beijing, China
Peking University Third HospitalCompleted
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 InstituteActive Not Recruiting
Dorado, Puerto Rico
Isis Clinical Research CenterActive Not Recruiting
Guaynabo, Puerto Rico