A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity
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
4 other identifiers
interventional
600
7 countries
80
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 obesity
Started May 2025
Typical duration for phase_3 obesity
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2025
CompletedFirst Posted
Study publicly available on registry
May 15, 2025
CompletedStudy Start
First participant enrolled
May 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
April 24, 2026
April 1, 2026
2.2 years
May 7, 2025
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change from Baseline in Body Weight
Baseline, Week 72
Secondary Outcomes (9)
Percentage of Participants Achieving Weight Reduction of ≥5%
Baseline up to 72 weeks
Change from Baseline in Waist Circumference
Baseline up to 72 weeks
Change from Baseline in Body Mass Index (BMI)
Baseline, Week 72
Change from Baseline in Systolic Blood Pressure (SBP)
Baseline up to 72 weeks
Percent Change from Baseline in Triglycerides
Baseline up to 72 weeks
- +4 more secondary outcomes
Study Arms (5)
Orforglipron Dose 1
EXPERIMENTALParticipants will receive orforglipron orally
Orforglipron Dose 2
EXPERIMENTALParticipants will receive orforglipron orally
Orforglipron Dose 3
EXPERIMENTALParticipants will receive orforglipron orally
Orforglipron Dose 4
EXPERIMENTALParticipants will receive orforglipron orally
Placebo
PLACEBO COMPARATORParticipants will receive placebo orally
Interventions
Administered orally
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (80)
Clinical Research Institute of Arizona (CRI) - Sun City West
Sun City West, Arizona, 85375, United States
Novak Clinical Research - Tucson - North La Cholla Boulevard
Tucson, Arizona, 85741, United States
Norcal Endocrinology & Internal Medicine
San Ramon, California, 94583, United States
Southern California Clinical Research
Santa Ana, California, 92701, United States
Care Access - Thousand Oaks
Thousand Oaks, California, 91360, United States
Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, 32720, United States
Innovation Medical Research Center - Fort Lauderdale
Fort Lauderdale, Florida, 33316, United States
Indago Research & Health Center, Inc
Hialeah, Florida, 33012, United States
Encore Medical Research
Hollywood, Florida, 33024, United States
West Orange Endocrinology P.A.
Ocoee, Florida, 34761, United States
Care Access - Tampa
Tampa, Florida, 33625, United States
Conquest Research
Winter Park, Florida, 32789, United States
Accel Research Sites - NeuroStudies Clinical Research Unit
Decatur, Georgia, 30030, United States
Care Access - Decatur
Decatur, Georgia, 30030, United States
Javara - Privia Medical Group Georgia - Savannah
Savannah, Georgia, 31406, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
Solaris Clinical Research
Meridian, Idaho, 83646, United States
Care Access - New Iberia
New Iberia, Louisiana, 70560, United States
Endocrine and Metabolic Consultants
Rockville, Maryland, 20852, United States
Javara - Privia Medical Group - Silver Spring
Silver Spring, Maryland, 20901, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
Boeson Research MSO
Missoula, Montana, 59804, United States
Javara - Nevada Health Centers - Carson City
Carson City, Nevada, 89706, United States
The Machuca Foundation
Las Vegas, Nevada, 89101, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514, United States
Javara - Tryon Medical Partners
Charlotte, North Carolina, 28210, United States
Care Access - Fayetteville
Fayetteville, North Carolina, 28314, United States
The Corvallis Clinic, P.C.
Corvallis, Oregon, 97330, United States
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, 19114, United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, 15478, United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230, United States
Biopharma Informatic, LLC
Houston, Texas, 77043, United States
Activian Clinical Research
Kingwood, Texas, 77339, United States
Texas Valley Clinical Research (TVCR) - Mission
Mission, Texas, 78572, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
CARE - Centro de Alergia y Enfermedades Respiratorias
Buenos Aires, 1414, Argentina
CIPREC
Buenos Aires, C1119ACN, Argentina
Centro Médico Viamonte
Buenos Aires, C1120AAC, Argentina
Instituto Centenario
CABA, 1204, Argentina
Instituto Médico Catamarca IMEC
Rosario, 2000, Argentina
Centro de Diagnóstico y Rehabilitación (CEDIR)
Santa Fe, 3000, Argentina
Xuanwu Hospital Capital Medical University
Beijing, 100053, China
Peking University Third Hospital
Beijing, 100091, China
Sichuan Provincial People's Hospital
Chengdu, 610072, China
The Second Affiliated Hospital Chongqing Medical University
Chongqing, 400010, China
Zhujiang Hospital
Guangzhou, 510280, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, 150001, China
The Second People's Hospital of Hefei
Hefei, 230011, China
Jinan Central Hospital
Jinan, 250013, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, 471003, China
Zhongda Hospital Southeast University
Nanjing, 210009, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, 210011, China
The Second Hospital of Tianjin Medical University
Tianjin, 300211, China
MUDr. Alena Vachova
České Budějovice, 37011, Czechia
Nemocnice Cesky Krumlov
Český Krumlov, 381 01, Czechia
Donmed s.r.o.
Ostrava, 710 00, Czechia
Milan Kvapil s.r.o., Diabetologicka ambulance
Prague, 14900, Czechia
Medical Plus
Uherské Hradiště, 686 01, Czechia
InnoDiab Forschung Gmbh
Essen, 45136, Germany
Medizentrum Essen Borbeck
Essen, 45355, Germany
Diabetes Zentrum Wilhelmsburg
Hamburg, 21109, Germany
AmBeNet GmbH
Leipzig, 04107, Germany
Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut
Leipzig, 04249, Germany
Medicover Neuroendokrinologie
Munich, 81667, Germany
RED-Institut GmbH
Oldenburg, 23758, Germany
Hasegawa Medicine Clinic
Chitose, 066-0032, Japan
The Institute of Medical Science, Asahi Life Foundation
Chūōku, 103-0002, Japan
Tokyo-Eki Center-building Clinic
Chūōku, 103-0027, Japan
Fukuwa Clinic
Chūōku, 104-0031, Japan
Tokuyama Clinic
Mihama-ku,Chiba City, 261-0004, Japan
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, 160-0008, Japan
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, 565-0853, Japan
Olive Takamatsu Medical Clinic
Takamatsu, 760-0076, Japan
Shimokitazawa Tomo Clinic
Tokyo, 155-0031, Japan
Tsuchiura Medical & Health Care Center
Tsuchiura, 300-0012, Japan
Noritake Clinic
Ushiku, 300-1207, Japan
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
Yamato-shi, 242-0004, Japan
Yokohama Minoru Clinic
Yokohama, 232-0064, Japan
Puerto Rico Health and Wellness Institute
Dorado, 00646, Puerto Rico
Isis Clinical Research Center
Guaynabo, 00968, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 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)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2025
First Posted
May 15, 2025
Study Start
May 15, 2025
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.