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NOT YET RECRUITING
NCT07794579
PHASE3

A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

Summary

This study will evaluate the efficacy and safety of orforglipron in participants with overweight and assess whether it helps reduce the future risk of obesity-related conditions, including type 2 diabetes, hypertension, and dyslipidemia, and progression to class 1 obesity.

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Once-Daily Oral Orforglipron Compared With Placebo in Individuals With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2001

Start Date

2026-09

Completion Date

2030-09

Last Updated

2026-08-31

Healthy Volunteers

No

Interventions

DRUG

Orforglipron

Administered orally

DRUG

Placebo

Administered orally

Locations (179)

Pinnacle Research Group, LLC

Anniston, Alabama, United States

Central Research Associates

Birmingham, Alabama, United States

Cahaba Research - Pelham

Pelham, Alabama, United States

Care Access - 801 South Power Road, Mesa

Mesa, Arizona, United States

Absolute Clinical Research

Phoenix, Arizona, United States

Synexus Clinical Research US, Inc./Orange Grove Family Practice

Tucson, Arizona, United States

Orange County Research Center

Lake Forest, California, United States

Healthy Brain Clinic

Long Beach, California, United States

Los Angeles Institute for Metabolic Research

Los Angeles, California, United States

Desert Oasis Healthcare Medical Group

Palm Springs, California, United States

Artemis Institute for Clinical Research

Riverside, California, United States

Riverside Clinical

Riverside, California, United States

Headlands Research- Sacramento

Sacramento, California, United States

Norcal Endocrinology & Internal Medicine

San Ramon, California, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Chase Medical Research, LLC

Waterbury, Connecticut, United States

Excel Medical Clinical Trials

Boca Raton, Florida, United States

Flourish Research Acquisition, LLC dba Flourish Research - North Miami

Miami, Florida, United States

New Age Medical Research Corporation

Miami, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Headlands Research Orlando

Orlando, Florida, United States

Oviedo Medical Research

Oviedo, Florida, United States

Care Access - St. Petersburg

St. Petersburg, Florida, United States

Precision Clinical Research

Sunrise, Florida, United States

SKY Clinical Research Network Group-Brown

Atlanta, Georgia, United States

HOPE Clinical Research & Wellness

Conyers, Georgia, United States

Care Access - Dalton Walmart

Dalton, Georgia, United States

Care Access - Decatur

Decatur, Georgia, United States

Family First Medical Center

Idaho Falls, Idaho, United States

Solaris Clinical Research

Meridian, Idaho, United States

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, United States

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

Cotton O'Neil Clinical Research Center

Topeka, Kansas, United States

Monroe Biomedical Research - Louisville

Louisville, Kentucky, United States

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

IMA Clinical Research Monroe-Main

Monroe, Louisiana, United States

Centennial Medical Group

Columbia, Maryland, United States

Brigham and Women's Hospital Diabetes Program

Boston, Massachusetts, United States

Great Lakes Research Group, Inc.

Bay City, Michigan, United States

Great Lakes Research Institute

Southfield, Michigan, United States

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, United States

Headlands Research-Twin Cities

Maplewood, Minnesota, United States

Clinvest Headlands Llc

Springfield, Missouri, United States

M3 Wake Research - Las Vegas Cimarron

Las Vegas, Nevada, United States

Renascor Clinical Research

Reno, Nevada, United States

IMA Clinical Research Warren

Warren Township, New Jersey, United States

Drug Trials America

Hartsdale, New York, United States

NYC Research INC

Long Island City, New York, United States

Rochester Clinical Research, LLC

Rochester, New York, United States

Medication Management

Greensboro, North Carolina, United States

West Clinical Research

Morehead City, North Carolina, United States

Trial Management Associates - Wilmington - Floral Parkway

Wilmington, North Carolina, United States

Lillestol Research

Fargo, North Dakota, United States

Remington-Davis, Inc

Columbus, Ohio, United States

Central States Research

Tulsa, Oklahoma, United States

The Corvallis Clinic, P.C.

Corvallis, Oregon, United States

Clinical Renal Associates Ltd.

Media, Pennsylvania, United States

Suburban Research Associates

West Chester, Pennsylvania, United States

Care Access - Mauldin

Mauldin, South Carolina, United States

New Phase Research and Development

Knoxville, Tennessee, United States

Clinical Research Associates Inc

Nashville, Tennessee, United States

IMA Clinical Research Austin

Austin, Texas, United States

Headlands Horizons, LLC dba Headlands Research-Brownsville

Brownsville, Texas, United States

Cedar Health Research - Texas Native Health

Dallas, Texas, United States

Headlands Research-El Paso

El Paso, Texas, United States

Cedar Health Research - Euless

Euless, Texas, United States

Biopharma Informatic, LLC

Houston, Texas, United States

Care Access - Houston - Clinical Trials Center by Walmart & Care Access

Houston, Texas, United States

Activian Clinical Research

Kingwood, Texas, United States

DCOL Center for Clinical Research

Longview, Texas, United States

IMA Clinical Research San Antonio

San Antonio, Texas, United States

VIP Trials

San Antonio, TX 78230, Texas, United States

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Care Access - Tyler - Clinical Trials Center by Walmart & Care Access

Tyler, Texas, United States

Sovah Clinical Research-River District

Danville, Virginia, United States

Clinical Research Partners, LLC

Richmond, Virginia, United States

CAMC Institute for Academic Medicine

Charleston, West Virginia, United States

Frontier Clinical Research, LLC

Kingwood, West Virginia, United States

CONEXA Investigacion Clinica S.A.

Buenos Aires, Argentina

CIPREC

Buenos Aires, Argentina

CARDIAMET Investigaciones Médicas

Buenos Aires, Argentina

Investigaciones Medicas Imoba Srl

Buenos Aires, Argentina

Centro Médico Viamonte

Buenos Aires, Argentina

CEMEDIC

Buenos Aires, Argentina

Fundación Respirar

Buenos Aires, Argentina

Instituto Centenario

CABA, Argentina

IDIM - Instituto de Investigaciones Metabólicas

Ciudad de Buenos Aires, Argentina

Sanatorio Esperanza

Esperanza, Argentina

Centro Diagnóstico Bioimagenes

Lanus, Argentina

Centro de Investigaciones Médicas Mar del Plata

Mar del Plata, Argentina

Instituto de Cardiología Wolff

Mendoza, Argentina

Instituto Especialidades de la Salud Rosario

Rosario, Argentina

Instituto de Investigaciones Clinicas Rosario

Rosario, Argentina

CardioAlem Investigaciones

San Isidro, Argentina

Instituto Médico de Alta Complejidad San Isidro Sa

San Isidro, Argentina

Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, Argentina

Instituto de Investigaciones Clínicas San Nicolas

San Nicolás de los Arroyos, Argentina

Centro de Investigaciones Clinicas del Litoral

Santa Fe, Argentina

Sichuan Provincial People's Hospital

Chengdu, China

The Second People's Hospital of Hefei

Hefei, China

The First Affiliated Hospital of Anhui Medical University

Hefei, China

Jinan Central Hospital

Jinan, China

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang Shi, China

Nanjing First Hospital

Nanjing, China

Jiangsu Province Official Hospital

Nanjing, China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, China

Ningbo First Hospital

Ningbo, China

The First Hospital of Qinhuangdao

Qinhuangdao Shi, China

Tianjin Medical University Zhu Xianyi Memorial Hospital

Tianjin, China

EFERTUS healthcare s.r.o.

Brno, Czechia

MUDr. Alena Vachova

České Budějovice, Czechia

Habrypraktik s.r.o.

Habry, Czechia

CCR Ostrava s.r.o

Ostrava, Czechia

Milan Kvapil s.r.o., Diabetologicka ambulance

Prague, Czechia

MUDr. Barbora Diepoltova

Praha 9 - Klanovice, Czechia

Medical Plus Research

Uherské Hradiště, Czechia

FutureMeds GmbH

Berlin, Germany

Siteworks GmbH - Bochum

Bochum, Germany

Siteworks GmbH - Hannover

Hanover, Germany

Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels

Hohenmölsen, Germany

Siteworks - Karlsruhe

Karlsruhe, Germany

AmBeNet GmbH

Leipzig, Germany

Rahman & Detho Studien GmbH

Obertshausen, Germany

Dedicated Research Site FutureMeds

Offenbach, Germany

RED-Institut GmbH

Oldenburg, Germany

Sanos Clinic

Ratingen, Germany

Jawaharlal Nehru Medical College

Aligarh, India

GMERS Medical College and General Hospital

Baroda, India

Endolife Speciality Hospitals

Guntur, India

Karnataka Institute of Medical Sciences

Hubli, India

Eternal Heart Care Center and Research Institute

Jaipur, India

Mysore Medical College

Mysore, India

Datta Meghe Institute of Medical Sciences (DMIMS) - Shalinitai Meghe Hospital and Research Center

Nagpur, India

Jothydev's Diabetes and Research Center

Trivandrum, India

Christian Medical College Vellore

Vellore, India

Nihonbashi Sakura Clinic

Chūōku, Japan

Tokyo Asbo Clinic

Chūōku, Japan

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, Japan

Tsuchiura Medical & Health Care Center

Tsuchiura, Japan

Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.

Ciudad Madero, Mexico

Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.

Culiacán, Mexico

Diseno y Planeacion en Investigacion Medica - Guadalajara - Calle Amado Nervo

Guadalajara, Mexico

Gastrobariátrica Santa Fe

Mexico City, Mexico

Kohler & Milstein Research S.A. De C.V.

Mérida, Mexico

Medical Care and Research SA de CV

Mérida, Mexico

Centro de investigación y control metabólico

Monterrey, Mexico

Servicios Integrales Nova de Monterrey S.A. de C.V.

San Nicolás de los Garza, Mexico

Medimanage Research

Tlalpan, Mexico

Ponce Medical School Foundation Inc.

Ponce, Puerto Rico

Latin Clinical Trial Center

San Juan, Puerto Rico

Mgcendo Llc

San Juan, Puerto Rico

Korea University Ansan Hospital

Ansan-si, South Korea

Hallym University Sacred Heart Hospital

Anyang-si, South Korea

Pusan National University Yangsan Hospital

Busan, South Korea

Hanyang University Guri Hospital

Guri-si, South Korea

Chosun University Hospital

Gwangju, South Korea

Kyungpook National University Hospital

Junggu, South Korea

Konyang University Hospital

Seogu, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea

CHA Bundang Medical Center, CHA University

Seongnam-si, South Korea

Korea University Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Hanyang University Seoul Hospital

Seoul, South Korea

Accellacare España

Alcobendas, Spain

EAP Sardenya

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

EAP Osona Sud - Alt Congost S.L.P

Centelles, Spain

C.R.A. Investigación Clínica

Ferrol, Spain

Hospital Vithas La Salud

Granada, Spain

FutureMeds - Madrid

Madrid, Spain

Centro de Salud San Juan de la Cruz

Pozuelo de Alarcón, Spain

Vithas Hospital Sevilla

Seville, Spain

Hospital Ascires

Valencia, Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Cathay General Hospital

Taipei, Taiwan