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NCT07223593PHASE3Recruiting

Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

Eli Lilly and Company

Start Date

10/31/2025

Completion Date

6/1/2028

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Have symptomatic PAD with intermittent claudication of Fontaine Stage II * Have an Ankle Brachial Index (ABI) of 0.9 or less Exclusion Criteria: * Have a body mass index (BMI) less than 23 kilogram per square meter (kg/m2) * Have Hemoglobin A1c (HbA1c) greater than 10% * Have walking ability limited by conditions other than PAD * Have a planned lower limb surgery or any other surgery affecting walking ability * Had peripheral revascularization procedure within 90 days prior to the day of screening or planning to undergo peripheral revascularization during the clinical trial * Had stroke, transient ischemic attack, myocardial infarction, coronary or carotid revascularization, or hospitalization for unstable angina pectoris within 60 days prior to screening * Have heart failure presently classified as being in New York Heart Association class III - IV

Interventions

DRUG

Orforglipron

DRUG

Placebo

Interested in This Trial?

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Conditions

Peripheral Arterial Disease

Locations

St. Vincent's Birmingham Hospital

Birmingham, Alabama 35205

United States

Mercy Gilbert Medical Center

Gilbert, Arizona 85297

United States

Emvera Health at Peak Heart & Vascular Surprise

Surprise, Arizona 85378

United States

Del Sol Research Management, LLC

Tucson, Arizona 85715

United States

Angel City Research Inc.

Los Angeles, California 90010

United States

Valley Clinical Trials, LLC dba Flourish Research

Northridge, California 91325

United States

The Cardiovascular Center

Redding, California 96001

United States

InvivoCure

Van Nuys, California 91405

United States

Interventional Cardiology Medical Group

West Hills, California 91307

United States

Rocky Mountain Regional VA Medical Center

Aurora, Colorado 80045

United States

Lakeview Institute of Clinical Research

Leesburg, Florida 34748

United States

Inpatient Research Clinic

Miami Lakes, Florida 33014

United States

Floridian Clinical Research, LLC

Miami Lakes, Florida 33016-1518

United States

St Johns Center for Clinical Research

Saint Augustine, Florida 32086

United States

ASHA Clinical Research - Munster, LLC

Hammond, Indiana 46324

United States

Indiana University Health Methodist Hospital

Indianapolis, Indiana 46202

United States

Deaconess Clinic- Gateway

Newburgh, Indiana 47630

United States

Flourish Research - Bowie

Bowie, Maryland 20715

United States

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan 48098

United States

Capital Area Research, LLC

Camp Hill, Pennsylvania 17011

United States

The Jackson Clinic

Jackson, Tennessee 38305

United States

East Coast Institute for Research - Jefferson City

Jefferson City, Tennessee 37760

United States

Biopharma Informatic, LLC

Houston, Texas 77084

United States

Research Physicians Network, LLC

Houston, Texas 77089

United States

Sherman Clinical Research

Sherman, Texas 75090

United States

NextStage Clinical Research - Waco

Waco, Texas 76712

United States

Alpine Research Organization

Clinton, Utah 84015

United States

Stroobants Cardiovascular Center

Lynchburg, Virginia 24501

United States

Clinical Research Partners, LLC

Richmond, Virginia 23226

United States

Gershon Pain Specialists

Virginia Beach, Virginia 23454

United States

ERA Health Research - CardioNow - Lynnwood

Lynnwood, Washington 98036

United States

Eastside Research Associates

Redmond, Washington 98052

United States

CIPREC

Buenos Aires, 1061

Argentina

CIPREC

Buenos Aires, C1119ACN

Argentina

Sanatorio Finochietto

Buenos Aires, C1187AAN

Argentina

CEMEDIC

Buenos Aires, C1407GTN

Argentina

Instituto de Investigaciones Clínicas Córdoba

Córdoba, 5000

Argentina

MICA - Medicina e Investigación Cardiometabólica

Del Viso, 1669

Argentina

Centro de Investigaciones Clínicas Baigorria

Granadero Baigorria, 2152

Argentina

DIM Clínica Privada

Ramos Mejía, B1704ETD

Argentina

Fundacion Estudios Clinicos

Rosario, 2000

Argentina

INECO Neurociencias Oroño

Rosario, 2000

Argentina

Instituto de Investigaciones Clinicas Rosario

Rosario, S2000CVD

Argentina

Go Centro Medico San Nicolás

San Nicolás, 2900

Argentina

Centro de Salud e Investigaciones Médicas

Santa Rosa, L6300

Argentina

Box Hill Hospital

Box Hill, 3128

Australia

Core Research Group

Brisbane, 4064

Australia

Heart of Australia

Brisbane, 4068

Australia

Canberra Hospital

Canberra, 2605

Australia

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

Meadowbrook, 4131

Australia

Royal Perth Hospital

Perth, 6000

Australia

Gold Coast University Hospital

Southport, 4215

Australia

Centro de Pesquisa Clinica do Coracao

Aracaju, 49055-530

Brazil

Hospital Universitário João de Barros Barreto

Belém, 66073-000

Brazil

Instituto de Pesquisa clinica de Campinas

Campinas, 13060-080

Brazil

Centro de Pesquisa Sao Lucas

Campinas, 13060-803

Brazil

Universidade Federal de Goias

Goiânia, 74605-020

Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, 90035-903

Brazil

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

Ribeirão Preto, 14026-020

Brazil

Instituto de Molestias Cardiovasculares de Tatui

Tatuí, 18270-170

Brazil

THEO Medical Concorde

Laval, H7G 2E6

Canada

Alpha Recherche Clinique - Lévis

Lévis, G6V 0C9

Canada

KMH Cardiology Centres - Stoney Creek

Stoney Creek, L8J 3W2

Canada

Corcare

Toronto, M1B 5N1

Canada

Unity Health Toronto, St. Michael's Hospital

Toronto, M5B 1W8

Canada

Toronto General Hospital

Toronto, M5G 2C4

Canada

Cardio 1 Medical Clinic

Winnipeg, R3L 1Z5

Canada

Xuanwu Hospital Capital Medical University

Beijing, 100053

China

Peking University Third Hospital

Beijing, 100091

China

Beijing Pinggu District Hospital

Beijing, 101200

China

Sichuan Provincial People's Hospital

Chengdu, 610072

China

Guangdong Provincial People's Hospital

Guangzhou, 510000

China

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, 150001

China

Heilongjiang Provincial Hospital

Harbin, 150036

China

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang Shi, 471003

China

Nanjing First Hospital

Nanjing, 210006

China

Nanjing First Hospital

Nanjing, 210012

China

Jiangsu Province Hospital

Nanjing, 210029

China

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

Shanghai, 200023

China

Zhongshan Hospital,Fudan University

Shanghai, 200032

China

Tianjin Medical University General Hospital

Tianjin, 300052

China

Tianjin People' s Hospital

Tianjin, 300121

China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325000

China

Wuhan University Medical College - Hubei Zhongshan Hospital

Wuhan, 430000

China

The First Affiliated Hospital of Xi'an Medical University

Xi'an, 710077

China

Centre Hospitalier Universitaire d'Angers

Angers, 49933

France

CHRU Troussau

Chambray-lès-Tours, 37170

France

Hôpital Saint Philibert

Lomme, 59160

France

Centre Hospitalier Universitaire de Nice - Hopital Pasteur

Nice, 06000

France

Groupe hospitalier Paris saint Joseph

Paris, 75014

France

Hôpital Européen Georges Pompidou

Paris, 75015

France

Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou

Rennes, 35033

France

Jawaharlal Nehru Medical College

Aligarh, 202002

India

Priyanka Hospital & Cardiac Center

Jaipur, 302020

India

M. P. Birla Group - Belle Vue Clinic

Kolkata, 700017

India

Government Medical College - Kozhikode

Kozhikode, 673008

India

Central India Cardiology and Research Institute

Nagpur, 440015

India

Lata Mangeshkar Hospital - Digdoh

Nagpur, 440019

India

All India Institute of Medical Sciences (AIIMS) - Nagpur

Nagpur, 441108

India

Vijan Hospital & Research Centre

Nashik, 422005

India

Sir Ganga Ram Hospital

New Delhi, 110060

India

All India Institute of Medical Sciences - Rishikesh

Rishikesh, 249203

India

Nirmal Hospital Pvt Ltd.

Surat, 395002

India

University of Yamanashi Hospital

Chūō, 409-3898

Japan

Fukuyama City Hospital

Fukuyama, 721-8511

Japan

Hakodate Municipal Hospital

Hakodate, 041-8680

Japan

Medical Corporation Sapporo Heart Center Sapporo Cardio Vascular Clinic

Higashi, 007-0849

Japan

Mito Medical Center

Higashiibaraki, 311-3117

Japan

National Hospital Organization Kanazawa Medical Center

Kanazawa, 920-8650

Japan

Shinyurigaoka General Hospital

Kawasaki, 215-0026

Japan

Kokura Memorial Hospital

Kitakyushu, 802-8555

Japan

Kobe City Medical Center General Hospital

Kobe, 650-0047

Japan

Omi Medical Center

Kusatsu, 525-0066

Japan

Seikeikai Medical Corporation New Tokyo Heart Clinic

Matsudo, 271-0077

Japan

Tokyo Saiseikai Central Hospital

Minatoku, 108-0073

Japan

Japanese Red Cross Musashino Hospital

Musashino-shi, 180-8610

Japan

Koujunkai Daido Clinic

Nagoya, 457-8511

Japan

Nakakinen clinic

Naka, 311-0113

Japan

National Hospital Organization Osaka National Hospital

Osaka, 540-0006

Japan

Osaka Keisatsu Hospital

Osaka, 543-0042

Japan

Kansai Electric Power Hospital

Osaka, 553-0003

Japan

Osaka General Medical Center

Osaka, 558-8558

Japan

Oita Oka Hospital

Ōita, 870-0192

Japan

Saitama City Hospital

Saitama, 336-8522

Japan

Japan Community Healthcare Organization Hokkaido Hospital

Sapporo, 062-8618

Japan

Iwate Medical University Hospital

Shiwa-gun Yahaba-cho, 028-3695

Japan

Municipal Toyonaka Hospital

Toyonaka, 560-0055

Japan

Yamagata University Hospital

Yamagata, 990-9585

Japan

Yokohama City Minato Red Cross Hospital

Yokohama, 231-0801

Japan

Albert Schweitzer Ziekenhuis, locatie Dordwijk

Dordrecht, 3318 AT

Netherlands

Catharina Ziekenhuis

Eindhoven, 5623 EJ

Netherlands

Radboudumc

Nijmegen, 6525 GA

Netherlands

Centrum Medyczne INTERCOR Sp. z o.o.

Bydgoszcz, 85-605

Poland

NZOZ Twoje Zdrowie EL Sp. z o. o.

Elblag, 82-300

Poland

Przychodnie Grudziądz

Grudziądz, 86-300

Poland

Centrum Medyczne Komorniki

Komorniki, 62-052

Poland

Poliklinika Kardiologiczna Serce

Leszno, 64-100

Poland

Centrum Badań Klinicznych Piotr Napora lekarze sp.p.

Wroclaw, 51-162

Poland

Pracownia Badań Klinicznych Salus

Wroclaw, 53-034

Poland

Research and Cardiovascular Corp.

Ponce, 00717

Puerto Rico

MEDIVASA

Žilina, 01001

Slovakia

Daegu Catholic University Medical Center

Daegu, 42472

South Korea

Korea University Anam Hospital

Seoul, 02841

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807

Taiwan

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung Niao Sung Dist, 83301

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, 333

Taiwan

Imperial College Healthcare NHS Trust, Charing Cross Hospital

London, W6 8RF

United Kingdom

Derriford Hospital

Plymouth, Pl6 8DH

United Kingdom

Royal Stoke University Hospital

Stoke-on-Trent, ST4 6QG

United Kingdom

Swansea University

Swansea, SA2 8PP

United Kingdom

Moorgreen Hospital

West End, SO30 3JB

United Kingdom