RecruitingPhase 3NCT06993792

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

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

Sponsor

Eli Lilly and Company

Enrollment

1,200 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity Overweight Type 2 Diabetes

Summary

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an umbrella study (master protocol) for a drug called orforglipron, a once-daily pill for weight management. The specific eligibility details depend on whether you have obesity without diabetes, or obesity with type 2 diabetes — please ask about the relevant sub-study (GZP1 or GZP2). **You may be eligible if...** - You have obesity or are overweight - You may or may not have type 2 diabetes - (Full eligibility details are in the specific sub-study protocols GZP1 or GZP2) **You may NOT be eligible if...** - (Detailed exclusion criteria are defined within GZP1 and GZP2) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOrforglipron

Administered orally

DRUGPlacebo

Administered orally

Locations(80)

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

Sun City West, Arizona, United States

Novak Clinical Research - Tucson - North La Cholla Boulevard

Tucson, Arizona, United States

Norcal Endocrinology & Internal Medicine

San Ramon, California, United States

Southern California Clinical Research

Santa Ana, California, United States

Care Access - Thousand Oaks

Thousand Oaks, California, United States

Accel Research Sites - DeLand Clinical Research Unit

DeLand, Florida, United States

Innovation Medical Research Center - Fort Lauderdale

Fort Lauderdale, Florida, United States

Indago Research & Health Center, Inc

Hialeah, Florida, United States

Encore Medical Research

Hollywood, Florida, United States

West Orange Endocrinology P.A.

Ocoee, Florida, United States

Care Access - Tampa

Tampa, Florida, United States

Conquest Research

Winter Park, Florida, United States

Accel Research Sites - NeuroStudies Clinical Research Unit

Decatur, Georgia, United States

Care Access - Decatur

Decatur, Georgia, United States

Javara - Privia Medical Group Georgia - Savannah

Savannah, Georgia, United States

North Georgia Clinical Research

Woodstock, Georgia, United States

Solaris Clinical Research

Meridian, Idaho, United States

Care Access - New Iberia

New Iberia, Louisiana, United States

Endocrine and Metabolic Consultants

Rockville, Maryland, United States

Javara - Privia Medical Group - Silver Spring

Silver Spring, Maryland, United States

Great Lakes Research Group, Inc.

Bay City, Michigan, United States

Boeson Research MSO

Missoula, Montana, United States

Javara - Nevada Health Centers - Carson City

Carson City, Nevada, United States

The Machuca Foundation

Las Vegas, Nevada, United States

University of North Carolina Medical Center

Chapel Hill, North Carolina, United States

Javara - Tryon Medical Partners

Charlotte, North Carolina, United States

Care Access - Fayetteville

Fayetteville, North Carolina, United States

The Corvallis Clinic, P.C.

Corvallis, Oregon, United States

Clinical Research of Philadelphia

Philadelphia, Pennsylvania, United States

Frontier Clinical Research, LLC

Smithfield, Pennsylvania, United States

Velocity Clinical Research, Dallas

Dallas, Texas, United States

Biopharma Informatic, LLC

Houston, Texas, United States

Activian Clinical Research

Kingwood, Texas, United States

Texas Valley Clinical Research (TVCR) - Mission

Mission, Texas, United States

Consano Clinical Research, LLC

Shavano Park, Texas, United States

CARE - Centro de Alergia y Enfermedades Respiratorias

Buenos Aires, Argentina

CIPREC

Buenos Aires, Argentina

Centro Médico Viamonte

Buenos Aires, Argentina

Instituto Centenario

CABA, Argentina

Instituto Médico Catamarca IMEC

Rosario, Argentina

Centro de Diagnóstico y Rehabilitación (CEDIR)

Santa Fe, Argentina

Xuanwu Hospital Capital Medical University

Beijing, China

Peking University Third Hospital

Beijing, China

Sichuan Provincial People's Hospital

Chengdu, China

The Second Affiliated Hospital Chongqing Medical University

Chongqing, China

Zhujiang Hospital

Guangzhou, China

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, China

The Second People's Hospital of Hefei

Hefei, China

Jinan Central Hospital

Jinan, China

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang Shi, China

Zhongda Hospital Southeast University

Nanjing, China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, China

The Second Hospital of Tianjin Medical University

Tianjin, China

MUDr. Alena Vachova

České Budějovice, Czechia

Nemocnice Cesky Krumlov

Český Krumlov, Czechia

Donmed s.r.o.

Ostrava, Czechia

Milan Kvapil s.r.o., Diabetologicka ambulance

Prague, Czechia

Medical Plus

Uherské Hradiště, Czechia

InnoDiab Forschung Gmbh

Essen, Germany

Medizentrum Essen Borbeck

Essen, Germany

Diabetes Zentrum Wilhelmsburg

Hamburg, Germany

AmBeNet GmbH

Leipzig, Germany

Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut

Leipzig, Germany

Medicover Neuroendokrinologie

Munich, Germany

RED-Institut GmbH

Oldenburg, Germany

Hasegawa Medicine Clinic

Chitose, Japan

The Institute of Medical Science, Asahi Life Foundation

Chūōku, Japan

Tokyo-Eki Center-building Clinic

Chūōku, Japan

Fukuwa Clinic

Chūōku, Japan

Tokuyama Clinic

Mihama-ku,Chiba City, Japan

Medical Corporation Heishinkai ToCROM Clinic

Shinjuku-ku, Japan

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, Japan

Olive Takamatsu Medical Clinic

Takamatsu, Japan

Shimokitazawa Tomo Clinic

Tokyo, Japan

Tsuchiura Medical & Health Care Center

Tsuchiura, Japan

Noritake Clinic

Ushiku, Japan

Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic

Yamato-shi, Japan

Yokohama Minoru Clinic

Yokohama, Japan

Puerto Rico Health and Wellness Institute

Dorado, Puerto Rico

Isis Clinical Research Center

Guaynabo, Puerto Rico

View Full Details on ClinicalTrials.gov

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