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
Status: Recruiting
Location: See all (161) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Have symptomatic PAD with intermittent claudication of Fontaine Stage II
• Have an Ankle Brachial Index (ABI) of 0.9 or less
Locations
United States
Alabama
St. Vincent's Birmingham Hospital
RECRUITING
Birmingham
Arizona
Mercy Gilbert Medical Center
RECRUITING
Gilbert
Emvera Health at Peak Heart & Vascular Surprise
NOT_YET_RECRUITING
Surprise
Del Sol Research Management, LLC
RECRUITING
Tucson
California
Angel City Research Inc.
NOT_YET_RECRUITING
Los Angeles
Valley Clinical Trials, LLC dba Flourish Research
RECRUITING
Northridge
The Cardiovascular Center
RECRUITING
Redding
InvivoCure
RECRUITING
Van Nuys
Interventional Cardiology Medical Group
RECRUITING
West Hills
Colorado
Rocky Mountain Regional VA Medical Center
NOT_YET_RECRUITING
Aurora
Florida
Lakeview Institute of Clinical Research
RECRUITING
Leesburg
Floridian Clinical Research, LLC
RECRUITING
Miami Lakes
Inpatient Research Clinic
RECRUITING
Miami Lakes
St Johns Center for Clinical Research
RECRUITING
Saint Augustine
Guardian Research Organization, LLC
NOT_YET_RECRUITING
Winter Park
Indiana
ASHA Clinical Research - Munster, LLC
RECRUITING
Hammond
Indiana University Health Methodist Hospital
RECRUITING
Indianapolis
Cardiovascular Research of Northwest Indiana
NOT_YET_RECRUITING
Munster
Deaconess Clinic- Gateway
RECRUITING
Newburgh
Maryland
Flourish Research - Bowie
RECRUITING
Bowie
Capitol Cardiology Associates - Lanham Office
NOT_YET_RECRUITING
Lanham
Michigan
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
RECRUITING
Troy
Pennsylvania
Capital Area Research, LLC
RECRUITING
Camp Hill
Tennessee
The Jackson Clinic
RECRUITING
Jackson
East Coast Institute for Research - Jefferson City
RECRUITING
Jefferson City
Texas
Biopharma Informatic, LLC
RECRUITING
Houston
Research Physicians Network, LLC
RECRUITING
Houston
Sherman Clinical Research
RECRUITING
Sherman
NextStage Clinical Research - Waco
RECRUITING
Waco
Utah
Alpine Research Organization
RECRUITING
Clinton
Virginia
Stroobants Cardiovascular Center
RECRUITING
Lynchburg
Carient Heart & Vascular - Manassas
NOT_YET_RECRUITING
Manassas
Clinical Research Partners, LLC
RECRUITING
Richmond
Gershon Pain Specialists
RECRUITING
Virginia Beach
Washington
ERA Health Research - CardioNow - Lynnwood
RECRUITING
Lynnwood
Eastside Research Associates
RECRUITING
Redmond
Other Locations
Argentina
CEMEDIC
RECRUITING
Buenos Aires
CIPREC
RECRUITING
Buenos Aires
CIPREC
NOT_YET_RECRUITING
Buenos Aires
Sanatorio Finochietto
RECRUITING
Buenos Aires
Instituto de Investigaciones Clínicas Córdoba
RECRUITING
Córdoba
MICA - Medicina e Investigación Cardiometabólica
NOT_YET_RECRUITING
Del Viso
Centro de Investigaciones Clínicas Baigorria
NOT_YET_RECRUITING
Granadero Baigorria
DIM Clínica Privada
RECRUITING
Ramos Mejía
Fundacion Estudios Clinicos
NOT_YET_RECRUITING
Rosario
INECO Neurociencias Oroño
RECRUITING
Rosario
Instituto de Investigaciones Clinicas Rosario
RECRUITING
Rosario
Go Centro Medico San Nicolás
RECRUITING
San Nicolás
Centro de Salud e Investigaciones Médicas
RECRUITING
Santa Rosa
Australia
Box Hill Hospital
RECRUITING
Box Hill
Core Research Group
RECRUITING
Brisbane
Heart of Australia
NOT_YET_RECRUITING
Brisbane
Canberra Hospital
RECRUITING
Canberra
Barwon Health
NOT_YET_RECRUITING
Geelong
University of the Sunshine Coast (UniSC) Clinical Trials - Meadowbrook
RECRUITING
Meadowbrook
Royal Perth Hospital
RECRUITING
Perth
Gold Coast University Hospital
RECRUITING
Southport
Royal North Shore Hospital
NOT_YET_RECRUITING
St Leonards
Brazil
Centro de Pesquisa Clinica do Coracao
RECRUITING
Aracaju
Hospital Universitário João de Barros Barreto
NOT_YET_RECRUITING
Belém
Centro de Pesquisa Sao Lucas
RECRUITING
Campinas
Instituto de Pesquisa clinica de Campinas
RECRUITING
Campinas
Universidade Federal de Goias
RECRUITING
Goiânia
Hospital de Clinicas de Porto Alegre
RECRUITING
Porto Alegre
Centro Avançado De Pesquisa, Estudos E Diagnóstico (CAPED) - Centro Médico RibeirãoShopping
RECRUITING
Ribeirão Preto
Instituto de Molestias Cardiovasculares de Tatui
RECRUITING
Tatuí
Canada
THEO Medical Concorde
RECRUITING
Laval
Alpha Recherche Clinique - Lévis
RECRUITING
Lévis
KMH Cardiology Centres - Stoney Creek
RECRUITING
Stoney Creek
Corcare
RECRUITING
Toronto
Toronto General Hospital
NOT_YET_RECRUITING
Toronto
Unity Health Toronto, St. Michael's Hospital
NOT_YET_RECRUITING
Toronto
Cardio 1 Medical Clinic
RECRUITING
Winnipeg
China
Beijing Pinggu District Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Xuanwu Hospital Capital Medical University
RECRUITING
Beijing
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Heilongjiang Provincial Hospital
RECRUITING
Harbin
The Fourth Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING
Harbin
The First Affiliated Hospital of Henan University of Science &Technology
RECRUITING
Luoyang Shi
Jiangsu Province Hospital
RECRUITING
Nanjing
Nanjing First Hospital
RECRUITING
Nanjing
Nanjing First Hospital
RECRUITING
Nanjing
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Zhongshan Hospital,Fudan University
RECRUITING
Shanghai
Tianjin Medical University General Hospital
RECRUITING
Tianjin
Tianjin People' s Hospital
RECRUITING
Tianjin
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Wuhan University Medical College - Hubei Zhongshan Hospital
RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Medical University
RECRUITING
Xi'an
France
Centre Hospitalier Universitaire d'Angers
RECRUITING
Angers
CHRU Troussau
RECRUITING
Chambray-lès-tours
Hôpital Saint Philibert
RECRUITING
Lomme
Centre Hospitalier Universitaire de Nice - Hopital Pasteur
RECRUITING
Nice
Groupe hospitalier Paris saint Joseph
RECRUITING
Paris
Hôpital Européen Georges Pompidou
RECRUITING
Paris
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
RECRUITING
Rennes
India
Jawaharlal Nehru Medical College
RECRUITING
Aligarh
Priyanka Hospital & Cardiac Center
NOT_YET_RECRUITING
Jaipur
M. P. Birla Group - Belle Vue Clinic
RECRUITING
Kolkata
Government Medical College - Kozhikode
RECRUITING
Kozhikode
All India Institute of Medical Sciences (AIIMS) - Nagpur
RECRUITING
Nagpur
Central India Cardiology and Research Institute
NOT_YET_RECRUITING
Nagpur
Lata Mangeshkar Hospital - Digdoh
RECRUITING
Nagpur
Vijan Hospital & Research Centre
RECRUITING
Nashik
Sir Ganga Ram Hospital
RECRUITING
New Delhi
All India Institute of Medical Sciences - Rishikesh
RECRUITING
Rishikesh
Nirmal Hospital Pvt Ltd.
NOT_YET_RECRUITING
Surat
Israel
Hadassah Medical Center
NOT_YET_RECRUITING
Jerusalem
Japan
University of Yamanashi Hospital
RECRUITING
Chūō
Fukuyama City Hospital
RECRUITING
Fukuyama
Hakodate Municipal Hospital
RECRUITING
Hakodate
Medical Corporation Sapporo Heart Center Sapporo Cardio Vascular Clinic
RECRUITING
Higashi
Mito Medical Center
NOT_YET_RECRUITING
Higashiibaraki
National Hospital Organization Kanazawa Medical Center
RECRUITING
Kanazawa
Shinyurigaoka General Hospital
RECRUITING
Kawasaki
Kokura Memorial Hospital
RECRUITING
Kitakyushu
Kobe City Medical Center General Hospital
RECRUITING
Kobe
Omi Medical Center
RECRUITING
Kusatsu
Seikeikai Medical Corporation New Tokyo Heart Clinic
RECRUITING
Matsudo
Japanese Red Cross Musashino Hospital
RECRUITING
Musashino-shi
Koujunkai Daido Clinic
RECRUITING
Nagoya
Nakakinen clinic
RECRUITING
Naka
Oita Oka Hospital
NOT_YET_RECRUITING
Ōita
Kansai Electric Power Hospital
RECRUITING
Osaka
National Hospital Organization Osaka National Hospital
RECRUITING
Osaka
Osaka General Medical Center
RECRUITING
Osaka
Osaka Keisatsu Hospital
RECRUITING
Osaka
Saitama City Hospital
RECRUITING
Saitama
Japan Community Healthcare Organization Hokkaido Hospital
RECRUITING
Sapporo
Iwate Medical University Hospital
RECRUITING
Shiwa-gun Yahaba-cho
Municipal Toyonaka Hospital
RECRUITING
Toyonaka
Yamagata University Hospital
RECRUITING
Yamagata
Yokohama City Minato Red Cross Hospital
RECRUITING
Yokohama
Netherlands
Albert Schweitzer Ziekenhuis, locatie Dordwijk
NOT_YET_RECRUITING
Dordrecht
Catharina Ziekenhuis
NOT_YET_RECRUITING
Eindhoven
Radboudumc
NOT_YET_RECRUITING
Nijmegen
Poland
Centrum Medyczne INTERCOR Sp. z o.o.
RECRUITING
Bydgoszcz
NZOZ Twoje Zdrowie EL Sp. z o. o.
RECRUITING
Elblag
Przychodnie Grudziądz
RECRUITING
Grudziądz
Centrum Medyczne Komorniki
RECRUITING
Komorniki
Poliklinika Kardiologiczna Serce
RECRUITING
Leszno
KO-MED Centra Kliniczne
NOT_YET_RECRUITING
Puławy
Centrum Badań Klinicznych Piotr Napora lekarze sp.p.
NOT_YET_RECRUITING
Wroclaw
Pracownia Badań Klinicznych Salus
NOT_YET_RECRUITING
Wroclaw
Puerto Rico
Research and Cardiovascular Corp.
RECRUITING
Ponce
Republic of Korea
Daegu Catholic University Medical Center
RECRUITING
Daegu
Asan Medical Center
RECRUITING
Seoul
Korea University Anam Hospital
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Slovakia
MEDIVASA
RECRUITING
Žilina
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Chang Gung Memorial Hospital at Kaohsiung
RECRUITING
Kaohsiung Niao Sung Dist
National Taiwan University Hospital
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch
RECRUITING
Taoyuan
United Kingdom
Imperial College Healthcare NHS Trust, Charing Cross Hospital
RECRUITING
London
Derriford Hospital
RECRUITING
Plymouth
Royal Stoke University Hospital
RECRUITING
Stoke-on-trent
Swansea University
RECRUITING
Swansea
Moorgreen Hospital
RECRUITING
West End
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2025-10-31
Estimated Completion Date: 2028-06
Participants
Target number of participants: 1205
Treatments
Experimental: Orforglipron
Participants will receive orforglipron orally
Placebo_comparator: Placebo
Participants will receive placebo orally
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company