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A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Type 2 Diabetes
NCT06972472 · 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 main purpose of this study is to see how orforglipron, compared with placebo, helps improve glycemic control in participants with obesity or with overweight and type 2 diabetes. This trial is part of the master protocol study J2A-MC-GZPO.
Participation in the study will last about 18 months.
Eligibility criteria
Inclusion Criteria:
* Have body mass index (BMI) ≥25 kilograms per square meter (kg/m2) at screening
* Have type 2 diabetes
* Have hemoglobin A1c (HbA1c) ≥7% and ≤10% at screening
* Have a history of at least one unsuccessful dietary effort to lose body weight
Exclusion Criteria:
* Have type 1 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: 2025-05-19
Estimated completion: 2027-08
Last updated: 2025-11-04
Interventions
Drug: OrforglipronDrug: Placebo
Primary outcomes
- • Change from Baseline in Hemoglobin A1c (HbA1c) (Baseline, Week 40)
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 (77)
Clinical Research Institute of Arizona (CRI) - Sun City WestNot Yet Recruiting
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Southern California Clinical ResearchRecruiting
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Thousand Oaks, California, United States
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DeLand, Florida, United States
Innovation Medical Research Center - Fort LauderdaleRecruiting
Fort Lauderdale, Florida, United States
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Hialeah, Florida, United States
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Tampa, Florida, United States
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Decatur, Georgia, United States
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Woodstock, Georgia, United States
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Meridian, Idaho, United States
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New Iberia, Louisiana, United States
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Silver Spring, Maryland, United States
Boeson Research MSORecruiting
Missoula, Montana, United States
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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
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Charlotte, North Carolina, United States
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Fayetteville, North Carolina, United States
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Corvallis, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Centro Médico ViamonteRecruiting
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Instituto CentenarioRecruiting
CABA, Argentina
Instituto Médico Catamarca IMECRecruiting
Rosario, Argentina
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Santa Fe, Argentina
Xuanwu Hospital Capital Medical UniversityRecruiting
Beijing, China
Peking University Third HospitalRecruiting
Beijing, China
Sichuan Provincial People's HospitalRecruiting
Chengdu, China
The Second Affiliated Hospital Chongqing Medical UniversityRecruiting
Chongqing, China
Zhujiang HospitalRecruiting
Guangzhou, China
The Fourth Affiliated Hospital of Harbin Medical UniversityRecruiting
Harbin, China
The Second People's Hospital of HefeiRecruiting
Hefei, China
Jinan Central HospitalRecruiting
Jinan, China
The First Affiliated Hospital of Henan University of Science &TechnologyRecruiting
Luoyang Shi, China
Zhongda Hospital Southeast UniversityRecruiting
Nanjing, China
The Second Affiliated Hospital of Nanjing Medical UniversityRecruiting
Nanjing, China
The Second Hospital of Tianjin Medical UniversityRecruiting
Tianjin, China
MUDr. Alena VachovaRecruiting
České Budějovice, Czechia
Nemocnice Cesky KrumlovRecruiting
Český Krumlov, Czechia
VASOMED ClinicRecruiting
Ostrava, Czechia
Milan Kvapil s.r.o., Diabetologicka ambulanceRecruiting
Prague, Czechia
Medical PlusRecruiting
Uherské Hradiště, Czechia
InnoDiab Forschung GmbhRecruiting
Essen, Germany
Medizentrum Essen BorbeckRecruiting
Essen, Germany
Diabetes Zentrum WilhelmsburgRecruiting
Hamburg, Germany
AmBeNet GmbHRecruiting
Leipzig, Germany
Gemeinschaftspraxis Dr. Taeschner/Dr. BonigutRecruiting
Leipzig, Germany
Medicover NeuroendokrinologieRecruiting
Munich, Germany
RED-Institut GmbHRecruiting
Oldenburg, Germany
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Chitose, Japan
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Chūōku, Japan
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Chūōku, Japan
Tokuyama ClinicRecruiting
Mihama-ku,Chiba City, Japan
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Shinjuku-ku, Japan
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Shimokitazawa Tomo ClinicRecruiting
Tokyo, Japan
Tsuchiura Medical & Health Care CenterRecruiting
Tsuchiura, Japan
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