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

NCT ID: NCT06993792

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-15

Study Completion Date

2027-08-31

Brief Summary

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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).

Detailed Description

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Conditions

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Obesity Overweight Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase 3b
Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Orforglipron Dose 1 (Study GZP1)

Participants will receive orforglipron orally

Group Type EXPERIMENTAL

Orforglipron

Intervention Type DRUG

Administered orally

Orforglipron Dose 2 (Study GZP1)

Participants will receive orforglipron orally

Group Type EXPERIMENTAL

Orforglipron

Intervention Type DRUG

Administered orally

Orforglipron Dose 3 (Study GZP1)

Participants will receive orforglipron orally

Group Type EXPERIMENTAL

Orforglipron

Intervention Type DRUG

Administered orally

Orforglipron Dose 4 (Study GZP1)

Participants will receive orforglipron orally

Group Type EXPERIMENTAL

Orforglipron

Intervention Type DRUG

Administered orally

Placebo (Study GZP1)

Participants will receive placebo orally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Orforglipron Dose 1 (Study GZP2)

Participants will receive orforglipron orally

Group Type EXPERIMENTAL

Orforglipron

Intervention Type DRUG

Administered orally

Orforglipron Dose 2 (Study GZP2)

Participants will receive orforglipron orally

Group Type EXPERIMENTAL

Orforglipron

Intervention Type DRUG

Administered orally

Orforglipron Dose 3 (Study GZP2)

Participants will receive orforglipron orally

Group Type EXPERIMENTAL

Orforglipron

Intervention Type DRUG

Administered orally

Orforglipron Dose 4 (Study GZP2)

Participants will receive orforglipron orally

Group Type EXPERIMENTAL

Orforglipron

Intervention Type DRUG

Administered orally

Placebo (Study GZP2)

Participants will receive placebo orally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Interventions

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Orforglipron

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Clinical Research Institute of Arizona (CRI) - Sun City West

Sun City West, Arizona, United States

Site Status NOT_YET_RECRUITING

Novak Clinical Research - Tucson - North La Cholla Boulevard

Tucson, Arizona, United States

Site Status RECRUITING

Norcal Endocrinology & Internal Medicine

San Ramon, California, United States

Site Status RECRUITING

Southern California Clinical Research

Santa Ana, California, United States

Site Status RECRUITING

Care Access - Thousand Oaks

Thousand Oaks, California, United States

Site Status RECRUITING

Accel Research Sites - DeLand Clinical Research Unit

DeLand, Florida, United States

Site Status RECRUITING

Innovation Medical Research Center - Fort Lauderdale

Fort Lauderdale, Florida, United States

Site Status RECRUITING

Indago Research & Health Center, Inc

Hialeah, Florida, United States

Site Status NOT_YET_RECRUITING

Encore Medical Research

Hollywood, Florida, United States

Site Status RECRUITING

West Orange Endocrinology P.A.

Ocoee, Florida, United States

Site Status RECRUITING

Care Access - Tampa

Tampa, Florida, United States

Site Status RECRUITING

Accel Research Sites - NeuroStudies Clinical Research Unit

Decatur, Georgia, United States

Site Status RECRUITING

Care Access - Decatur

Decatur, Georgia, United States

Site Status RECRUITING

Javara - Privia Medical Group Georgia - Savannah

Savannah, Georgia, United States

Site Status RECRUITING

North Georgia Clinical Research

Woodstock, Georgia, United States

Site Status RECRUITING

Solaris Clinical Research

Meridian, Idaho, United States

Site Status RECRUITING

Care Access - New Iberia

New Iberia, Louisiana, United States

Site Status RECRUITING

Endocrine and Metabolic Consultants

Rockville, Maryland, United States

Site Status RECRUITING

Javara - Privia Medical Group - Silver Spring

Silver Spring, Maryland, United States

Site Status RECRUITING

Boeson Research MSO

Missoula, Montana, United States

Site Status RECRUITING

Javara - Nevada Health Centers - Carson City

Carson City, Nevada, United States

Site Status RECRUITING

The Machuca Foundation

Las Vegas, Nevada, United States

Site Status RECRUITING

University of North Carolina Medical Center

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Javara - Tryon Medical Partners

Charlotte, North Carolina, United States

Site Status RECRUITING

Care Access - Fayetteville

Fayetteville, North Carolina, United States

Site Status RECRUITING

The Corvallis Clinic, P.C.

Corvallis, Oregon, United States

Site Status RECRUITING

Clinical Research of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Frontier Clinical Research, LLC

Smithfield, Pennsylvania, United States

Site Status RECRUITING

Velocity Clinical Research, Dallas

Dallas, Texas, United States

Site Status RECRUITING

Biopharma Informatic, LLC

Houston, Texas, United States

Site Status RECRUITING

Texas Valley Clinical Research (TVCR) - Mission

Mission, Texas, United States

Site Status RECRUITING

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Site Status RECRUITING

CARE - Centro de Alergia y Enfermedades Respiratorias

Buenos Aires, , Argentina

Site Status RECRUITING

CIPREC

Buenos Aires, , Argentina

Site Status RECRUITING

Centro Médico Viamonte

Buenos Aires, , Argentina

Site Status RECRUITING

Instituto Centenario

CABA, , Argentina

Site Status RECRUITING

Instituto Médico Catamarca IMEC

Rosario, , Argentina

Site Status RECRUITING

Centro de Diagnóstico y Rehabilitación (CEDIR)

Santa Fe, , Argentina

Site Status RECRUITING

Xuanwu Hospital Capital Medical University

Beijing, , China

Site Status RECRUITING

Peking University Third Hospital

Beijing, , China

Site Status RECRUITING

Sichuan Provincial People's Hospital

Chengdu, , China

Site Status RECRUITING

The Second Affiliated Hospital Chongqing Medical University

Chongqing, , China

Site Status RECRUITING

Zhujiang Hospital

Guangzhou, , China

Site Status RECRUITING

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, , China

Site Status RECRUITING

The Second People's Hospital of Hefei

Hefei, , China

Site Status RECRUITING

Jinan Central Hospital

Jinan, , China

Site Status RECRUITING

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang Shi, , China

Site Status RECRUITING

Zhongda Hospital Southeast University

Nanjing, , China

Site Status RECRUITING

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, , China

Site Status RECRUITING

The Second Hospital of Tianjin Medical University

Tianjin, , China

Site Status RECRUITING

MUDr. Alena Vachova

České Budějovice, , Czechia

Site Status RECRUITING

Nemocnice Cesky Krumlov

Český Krumlov, , Czechia

Site Status RECRUITING

VASOMED Clinic

Ostrava, , Czechia

Site Status RECRUITING

Milan Kvapil s.r.o., Diabetologicka ambulance

Prague, , Czechia

Site Status RECRUITING

Medical Plus

Uherské Hradiště, , Czechia

Site Status RECRUITING

InnoDiab Forschung Gmbh

Essen, , Germany

Site Status RECRUITING

Medizentrum Essen Borbeck

Essen, , Germany

Site Status RECRUITING

Diabetes Zentrum Wilhelmsburg

Hamburg, , Germany

Site Status RECRUITING

AmBeNet GmbH

Leipzig, , Germany

Site Status RECRUITING

Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut

Leipzig, , Germany

Site Status RECRUITING

Medicover Neuroendokrinologie

Munich, , Germany

Site Status RECRUITING

RED-Institut GmbH

Oldenburg, , Germany

Site Status RECRUITING

Hasegawa Medicine Clinic

Chitose, , Japan

Site Status RECRUITING

The Institute of Medical Science, Asahi Life Foundation

Chūōku, , Japan

Site Status RECRUITING

Tokyo-Eki Center-building Clinic

Chūōku, , Japan

Site Status RECRUITING

Fukuwa Clinic

Chūōku, , Japan

Site Status RECRUITING

Tokuyama Clinic

Mihama-ku,Chiba City, , Japan

Site Status RECRUITING

Medical Corporation Heishinkai ToCROM Clinic

Shinjuku-ku, , Japan

Site Status RECRUITING

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, , Japan

Site Status RECRUITING

Olive Takamatsu Medical Clinic

Takamatsu, , Japan

Site Status RECRUITING

Shimokitazawa Tomo Clinic

Tokyo, , Japan

Site Status RECRUITING

Tsuchiura Medical & Health Care Center

Tsuchiura, , Japan

Site Status RECRUITING

Noritake Clinic

Ushiku, , Japan

Site Status RECRUITING

Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic

Yamato-shi, , Japan

Site Status RECRUITING

Yokohama Minoru Clinic

Yokohama, , Japan

Site Status RECRUITING

Puerto Rico Health and Wellness Institute

Dorado, , Puerto Rico

Site Status RECRUITING

Isis Clinical Research Center

Guaynabo, , Puerto Rico

Site Status RECRUITING

Countries

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India Mexico United States Argentina China Czechia Germany Japan Puerto Rico

Central Contacts

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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Role: CONTACT

Phone: 1-317-615-4559

Email: [email protected]

Physicians interested in becoming principal investigators please contact

Role: CONTACT

Email: [email protected]

Facility Contacts

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Other Identifiers

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2025-521098-14-00

Identifier Type: CTIS

Identifier Source: secondary_id

J2A-MC-GZPO

Identifier Type: OTHER

Identifier Source: secondary_id

J2A-MC-GZP1

Identifier Type: OTHER

Identifier Source: secondary_id

J2A-MC-GZP2

Identifier Type: OTHER

Identifier Source: secondary_id

27266

Identifier Type: -

Identifier Source: org_study_id