A Master Protocol for Orforglipron (LY3502970) in Participants With Obesity or Overweight With and Without Type 2 Diabetes

April 23, 2026 updated by: Eli Lilly and Company

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1119ACN
        • CIPREC
      • Buenos Aires, Argentina, C1120AAC
        • Centro Medico Viamonte
      • Buenos Aires, Argentina, 1414
        • CARE - Centro de Alergia y Enfermedades Respiratorias
      • CABA, Argentina, 1204
        • Instituto Centenario
      • Rosario, Argentina, 2000
        • Instituto Médico Catamarca IMEC
      • Santa Fe, Argentina, 3000
        • Centro de Diagnóstico y Rehabilitación (CEDIR)
  • China
      • Beijing, China, 100053
        • Xuanwu Hospital Capital Medical University
      • Beijing, China, 100091
        • Peking University Third Hospital
      • Chengdu, China, 610072
        • Sichuan Provincial People's Hospital
      • Chongqing, China, 400010
        • The Second Affiliated Hospital Chongqing Medical University
      • Guangzhou, China, 510280
        • Zhujiang Hospital
      • Harbin, China, 150001
        • The Fourth Affiliated Hospital of Harbin Medical University
      • Hefei, China, 230011
        • The Second People's Hospital of Hefei
      • Jinan, China, 250013
        • Jinan Central Hospital
      • Luoyang Shi, China, 471003
        • The First Affiliated Hospital of Henan University of Science &Technology
      • Nanjing, China, 210009
        • Zhongda Hospital Southeast University
      • Nanjing, China, 210011
        • The Second Affiliated Hospital of Nanjing Medical University
      • Tianjin, China, 300211
        • The Second Hospital Of Tianjin Medical University
  • Czechia
      • Ostrava, Czechia, 710 00
        • Donmed s.r.o.
      • Prague, Czechia, 14900
        • Milan Kvapil s.r.o., Diabetologicka ambulance
      • Uherské Hradiště, Czechia, 686 01
        • Medical Plus
      • České Budějovice, Czechia, 37011
        • MUDr. Alena Vachova
      • Český Krumlov, Czechia, 381 01
        • Nemocnice Cesky krumlov
  • Germany
      • Essen, Germany, 45136
        • InnoDiab Forschung GmbH
      • Essen, Germany, 45355
        • Medizentrum Essen Borbeck
      • Hamburg, Germany, 21109
        • Diabetes Zentrum Wilhelmsburg
      • Leipzig, Germany, 04107
        • AmBeNet GmbH
      • Leipzig, Germany, 04249
        • Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut
      • Munich, Germany, 81667
        • Medicover Neuroendokrinologie
      • Oldenburg, Germany, 23758
        • Red-Institut GmbH
  • Japan
      • Chitose, Japan, 066-0032
        • Hasegawa Medicine Clinic
      • Chūōku, Japan, 103-0027
        • Tokyo-Eki Center-building Clinic
      • Chūōku, Japan, 104-0031
        • Fukuwa Clinic
      • Chūōku, Japan, 103-0002
        • The Institute of Medical Science, Asahi Life Foundation
      • Mihama-ku,Chiba City, Japan, 261-0004
        • Tokuyama Clinic
      • Shinjuku-ku, Japan, 160-0008
        • Medical Corporation Heishinkai ToCROM Clinic
      • Suita-shi, Japan, 565-0853
        • Medical Corporation Heishinkai OCROM Clinic
      • Takamatsu, Japan, 760-0076
        • Olive Takamatsu Medical Clinic
      • Tokyo, Japan, 155-0031
        • Shimokitazawa Tomo Clinic
      • Tsuchiura, Japan, 300-0012
        • Tsuchiura Medical & Health Care Center
      • Ushiku, Japan, 300-1207
        • Noritake Clinic
      • Yamato-shi, Japan, 242-0004
        • Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
      • Yokohama, Japan, 232-0064
        • Yokohama Minoru Clinic
  • Puerto Rico
      • Dorado, Puerto Rico, 00646
        • Puerto Rico Health and Wellness Institute
      • Guaynabo, Puerto Rico, 00968
        • Isis Clinical Research Center
  • United States
    • Arizona
      • Sun City West, Arizona, United States, 85375
        • Clinical Research Institute of Arizona (CRI) - Sun City West
      • Tucson, Arizona, United States, 85741
        • Novak Clinical Research - Tucson - North La Cholla Boulevard
    • California
      • San Ramon, California, United States, 94583
        • Norcal Endocrinology & Internal Medicine
      • Santa Ana, California, United States, 92701
        • Southern California Clinical Research
      • Thousand Oaks, California, United States, 91360
        • Care Access - Thousand Oaks
    • Florida
      • DeLand, Florida, United States, 32720
        • Accel Research Sites - Deland Clinical Research Unit
      • Fort Lauderdale, Florida, United States, 33316
        • Innovation Medical Research Center - Fort Lauderdale
      • Hialeah, Florida, United States, 33012
        • Indago Research & Health Center, Inc
      • Hollywood, Florida, United States, 33024
        • Encore Medical Research
      • Ocoee, Florida, United States, 34761
        • West Orange Endocrinology P.A.
      • Tampa, Florida, United States, 33625
        • Care Access - Tampa
      • Winter Park, Florida, United States, 32789
        • Conquest Research
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Care Access - Decatur
      • Decatur, Georgia, United States, 30030
        • Accel Research Sites - NeuroStudies Clinical Research Unit
      • Savannah, Georgia, United States, 31406
        • Javara - Privia Medical Group Georgia - Savannah
      • Woodstock, Georgia, United States, 30189
        • North Georgia Clinical Research
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Solaris Clinical Research
    • Louisiana
      • New Iberia, Louisiana, United States, 70560
        • Care Access - New Iberia
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Endocrine and Metabolic Consultants
      • Silver Spring, Maryland, United States, 20901
        • Javara - Privia Medical Group - Silver Spring
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Great Lakes Research Group, Inc.
    • Montana
      • Missoula, Montana, United States, 59804
        • Boeson Research MSO
    • Nevada
      • Carson City, Nevada, United States, 89706
        • Javara - Nevada Health Centers - Carson City
      • Las Vegas, Nevada, United States, 89101
        • The Machuca Foundation
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina Medical Center
      • Charlotte, North Carolina, United States, 28210
        • Javara - Tryon Medical Partners
      • Fayetteville, North Carolina, United States, 28314
        • Care Access - Fayetteville
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • The Corvallis Clinic, P.C.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Clinical Research of Philadelphia
      • Smithfield, Pennsylvania, United States, 15478
        • Frontier Clinical Research, LLC
    • Texas
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Research, Dallas
      • Houston, Texas, United States, 77043
        • Biopharma Informatic, LLC
      • Kingwood, Texas, United States, 77339
        • Activian Clinical Research
      • Mission, Texas, United States, 78572
        • Texas Valley Clinical Research (TVCR) - Mission
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Orforglipron Dose 1 (Study GZP1)
Participants will receive orforglipron orally
Drug: Orforglipron
Administered orally
Experimental: Orforglipron Dose 2 (Study GZP1)
Participants will receive orforglipron orally
Drug: Orforglipron
Administered orally
Experimental: Orforglipron Dose 3 (Study GZP1)
Participants will receive orforglipron orally
Drug: Orforglipron
Administered orally
Experimental: Orforglipron Dose 4 (Study GZP1)
Participants will receive orforglipron orally
Drug: Orforglipron
Administered orally
Placebo Comparator: Placebo (Study GZP1)
Participants will receive placebo orally
Drug: Placebo
Administered orally
Experimental: Orforglipron Dose 1 (Study GZP2)
Participants will receive orforglipron orally
Drug: Orforglipron
Administered orally
Experimental: Orforglipron Dose 2 (Study GZP2)
Participants will receive orforglipron orally
Drug: Orforglipron
Administered orally
Experimental: Orforglipron Dose 3 (Study GZP2)
Participants will receive orforglipron orally
Drug: Orforglipron
Administered orally
Experimental: Orforglipron Dose 4 (Study GZP2)
Participants will receive orforglipron orally
Drug: Orforglipron
Administered orally
Placebo Comparator: Placebo (Study GZP2)
Participants will receive placebo orally
Drug: Placebo
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Allocated to Each Study
Time Frame: Baseline to Week 4
Baseline to Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

May 7, 2025

First Submitted That Met QC Criteria

May 27, 2025

First Posted (Actual)

May 29, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27266
  • 2025-521098-14-00 (Ctis)
  • J2A-MC-GZP2 (Other Identifier: Eli Lilly and Company)
  • J2A-MC-GZPO (Other Identifier: Eli Lilly and Company)
  • J2A-MC-GZP1 (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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