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

July 30, 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1119ACN
        • CIPREC
      • Buenos Aires, Argentina, C1120AAC
        • Centro Médico 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 Váchová
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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