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RECRUITING
NCT07223593
PHASE3

Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the effect and safety of orforglipron once daily in participants with Fontaine II peripheral arterial disease (PAD). Participation in the study will last about 58 weeks.

Official title: A Study to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants With Peripheral Artery Disease: A Randomized, Double-Blind, Placebo Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1205

Start Date

2025-10-31

Completion Date

2028-06

Last Updated

2026-10-08

Healthy Volunteers

No

Interventions

DRUG

Orforglipron

Administered orally

DRUG

Placebo

Administered orally

Locations (170)

St. Vincent's Birmingham Hospital

Birmingham, Alabama, United States

Mercy Gilbert Medical Center

Gilbert, Arizona, United States

Emvera Health at Peak Heart & Vascular Surprise

Surprise, Arizona, United States

Del Sol Research Management, LLC

Tucson, Arizona, United States

Angel City Research Inc.

Los Angeles, California, United States

Valley Clinical Trials, LLC dba Flourish Research

Northridge, California, United States

The Cardiovascular Center

Redding, California, United States

InvivoCure

Van Nuys, California, United States

Interventional Cardiology Medical Group

West Hills, California, United States

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, United States

Lakeview Institute of Clinical Research

Leesburg, Florida, United States

Inpatient Research Clinic

Miami Lakes, Florida, United States

Floridian Clinical Research, LLC

Miami Lakes, Florida, United States

St Johns Center for Clinical Research

Saint Augustine, Florida, United States

Guardian Research Organization, LLC

Winter Park, Florida, United States

ASHA Clinical Research - Munster, LLC

Hammond, Indiana, United States

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States

Cardiovascular Research of Northwest Indiana

Munster, Indiana, United States

Deaconess Clinic- Gateway

Newburgh, Indiana, United States

Flourish Research - Bowie

Bowie, Maryland, United States

Capitol Cardiology Associates - Lanham Office

Lanham, Maryland, United States

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, United States

Capital Area Research, LLC

Camp Hill, Pennsylvania, United States

The Jackson Clinic

Jackson, Tennessee, United States

East Coast Institute for Research - Jefferson City

Jefferson City, Tennessee, United States

Biopharma Informatic, LLC

Houston, Texas, United States

Research Physicians Network, LLC

Houston, Texas, United States

Sherman Clinical Research

Sherman, Texas, United States

NextStage Clinical Research - Waco

Waco, Texas, United States

Alpine Research Organization

Clinton, Utah, United States

Stroobants Cardiovascular Center

Lynchburg, Virginia, United States

Carient Heart & Vascular - Manassas

Manassas, Virginia, United States

Clinical Research Partners, LLC

Richmond, Virginia, United States

Gershon Pain Specialists

Virginia Beach, Virginia, United States

ERA Health Research - CardioNow - Lynnwood

Lynnwood, Washington, United States

Eastside Research Associates

Redmond, Washington, United States

CIPREC

Buenos Aires, Argentina

CIPREC

Buenos Aires, Argentina

Sanatorio Finochietto

Buenos Aires, Argentina

CEMEDIC

Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Córdoba

Córdoba, Argentina

MICA - Medicina e Investigación Cardiometabólica

Del Viso, Argentina

Centro de Investigaciones Clínicas Baigorria

Granadero Baigorria, Argentina

DIM Clínica Privada

Ramos Mejía, Argentina

Fundacion Estudios Clinicos

Rosario, Argentina

INECO Neurociencias Oroño

Rosario, Argentina

Instituto de Investigaciones Clinicas Rosario

Rosario, Argentina

Go Centro Medico San Nicolás

San Nicolás, Argentina

Centro de Salud e Investigaciones Médicas

Santa Rosa, Argentina

Box Hill Hospital

Box Hill, Australia

Core Research Group

Brisbane, Australia

Heart of Australia

Brisbane, Australia

Canberra Hospital

Canberra, Australia

Barwon Health

Geelong, Australia

University of the Sunshine Coast (UniSC) Clinical Trials - Meadowbrook

Meadowbrook, Australia

Royal Perth Hospital

Perth, Australia

Gold Coast University Hospital

Southport, Australia

Royal North Shore Hospital

St Leonards, Australia

Centro de Pesquisa Clinica do Coracao

Aracaju, Brazil

Hospital Universitário João de Barros Barreto

Belém, Brazil

Instituto de Pesquisa clinica de Campinas

Campinas, Brazil

Centro de Pesquisa Sao Lucas

Campinas, Brazil

Universidade Federal de Goias

Goiânia, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Brazil

Centro Avançado De Pesquisa, Estudos E Diagnóstico (CAPED) - Centro Médico RibeirãoShopping

Ribeirão Preto, Brazil

Instituto de Molestias Cardiovasculares de Tatui

Tatuí, Brazil

THEO Medical Concorde

Laval, Canada

Alpha Recherche Clinique - Lévis

Lévis, Canada

KMH Cardiology Centres - Stoney Creek

Stoney Creek, Canada

Corcare

Toronto, Canada

Unity Health Toronto, St. Michael's Hospital

Toronto, Canada

Toronto General Hospital

Toronto, Canada

Cardio 1 Medical Clinic

Winnipeg, Canada

Xuanwu Hospital Capital Medical University

Beijing, China

Peking University Third Hospital

Beijing, China

Beijing Pinggu District Hospital

Beijing, China

Sichuan Provincial People's Hospital

Chengdu, China

Guangdong Provincial People's Hospital

Guangzhou, China

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, China

Heilongjiang Provincial Hospital

Harbin, China

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang Shi, China

Nanjing First Hospital

Nanjing, China

Nanjing First Hospital

Nanjing, China

Jiangsu Province Hospital

Nanjing, China

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Zhongshan Hospital,Fudan University

Shanghai, China

Tianjin Medical University General Hospital

Tianjin, China

Tianjin People' s Hospital

Tianjin, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Wuhan University Medical College - Hubei Zhongshan Hospital

Wuhan, China

The First Affiliated Hospital of Xi'an Medical University

Xi'an, China

Centre Hospitalier Universitaire d'Angers

Angers, France

CHRU Troussau

Chambray-lès-Tours, France

Hôpital Saint Philibert

Lomme, France

Centre Hospitalier Universitaire de Nice - Hopital Pasteur

Nice, France

Groupe hospitalier Paris saint Joseph

Paris, France

Hôpital Européen Georges Pompidou

Paris, France

Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou

Rennes, France

General Hospital of Athens Laiko

Athens, Greece

Athens Medical Center

Athens, Greece

And 70 more locations on ClinicalTrials.gov