Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease (ATTAIN-PAD)

April 16, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1205

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 317-615-4559
  • Email: LillyTrials@Lilly.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1187AAN
        • Not yet recruiting
        • Sanatorio Finochietto
        • Contact:
          • Phone Number: +5491164424757
        • Principal Investigator:
          • Nicolás Gonzalez
      • Buenos Aires, Argentina, C1407GTN
        • Not yet recruiting
        • CEMEDIC
        • Principal Investigator:
          • Claudio Majul
        • Contact:
          • Phone Number: 54 11 46356624
      • Buenos Aires, Argentina, C1119ACN
        • Not yet recruiting
        • CIPREC
        • Principal Investigator:
          • Angela Romero Zarante
        • Contact:
          • Phone Number: 5491165496764
      • Córdoba, Argentina, 5000
        • Not yet recruiting
        • Instituto de Investigaciones Clinicas Cordoba
        • Contact:
          • Phone Number: 543514253456
        • Principal Investigator:
          • Ines Bartolacci
      • Ramos Mejía, Argentina, B1704ETD
        • Not yet recruiting
        • DIM Clinica Privada
        • Principal Investigator:
          • Oscar Montaña
        • Contact:
          • Phone Number: 54011 46562828
      • Rosario, Argentina, 2000
        • Not yet recruiting
        • INECO Neurociencias Oroño
        • Principal Investigator:
          • Dana Miralles
        • Contact:
          • Phone Number: 543415004351
      • Rosario, Argentina, S2000CVD
        • Not yet recruiting
        • Instituto de Investigaciones Clínicas Rosario
        • Contact:
          • Phone Number: 5493415109204
        • Principal Investigator:
          • Carolina Chacón
      • San Nicolás, Argentina, 2900
        • Not yet recruiting
        • Go Centro Medico San Nicolas
        • Contact:
          • Phone Number: 5493364571637
        • Principal Investigator:
          • Paulina Lanchiotti
      • Santa Rosa, Argentina, L6300
        • Not yet recruiting
        • Centro de Salud e Investigaciones Médicas
        • Contact:
          • Phone Number: 542954244444
        • Principal Investigator:
          • Marcos Mayer
  • Australia
      • Box Hill, Australia, 3128
        • Recruiting
        • Box Hill Hospital
        • Principal Investigator:
          • Ming Li Yee
      • Brisbane, Australia, 4064
        • Not yet recruiting
        • Core Research Group
        • Contact:
          • Phone Number: 61738765688
        • Principal Investigator:
          • David Colquhoun
      • Canberra, Australia, 2605
        • Not yet recruiting
        • Canberra Hospital
        • Principal Investigator:
          • Peter Scott
      • Meadowbrook, Australia, 4131
        • Recruiting
        • University of the Sunshine Coast (UniSC) Clinical Trials - Meadowbrook
        • Principal Investigator:
          • Ivan Lim
      • Perth, Australia, 6000
        • Not yet recruiting
        • Royal Perth Hospital
        • Principal Investigator:
          • Nishath Altaf
      • Southport, Australia, 4215
        • Not yet recruiting
        • Gold Coast University Hospital
        • Contact:
          • Phone Number: 0438083132
        • Principal Investigator:
          • Jessica Triay
  • Brazil
      • Aracaju, Brazil, 49055-530
        • Not yet recruiting
        • Centro de Pesquisa Clínica do Coração
        • Principal Investigator:
          • FÁBIO SILVEIRA
        • Contact:
          • Phone Number: 557999987-0794
      • Belém, Brazil, 66073-000
        • Not yet recruiting
        • Hospital Universitário João de Barros Barreto
        • Principal Investigator:
          • Joao Felicio
        • Contact:
          • Phone Number: 559132291329
      • Campinas, Brazil, 13060-803
        • Not yet recruiting
        • Centro de Pesquisa Sao Lucas
        • Principal Investigator:
          • Danilo Villagelin Neto
        • Contact:
          • Phone Number: 55 19 3343-8688
      • Campinas, Brazil, 13060-080
        • Not yet recruiting
        • Instituto de Pesquisa Clinica de Campinas
        • Principal Investigator:
          • Jose Saraiva
        • Contact:
          • Phone Number: 1932670023
      • Goiânia, Brazil, 74605-020
        • Not yet recruiting
        • Universidade Federal de Goiás
        • Principal Investigator:
          • Aguinaldo Freitas
        • Contact:
          • Phone Number: 55 62 36448186
      • Porto Alegre, Brazil, 90035-903
        • Not yet recruiting
        • Hospital de Clinicas de Porto Alegre
        • Principal Investigator:
          • Adamastor Pereira
      • Ribeirão Preto, Brazil, 14026-020
        • Not yet recruiting
        • Centro Avançado De Pesquisa, Estudos E Diagnóstico (CAPED) - Centro Médico RibeirãoShopping
        • Contact:
          • Phone Number: 55 16 99118-2046
        • Principal Investigator:
          • Pedro Schwartzmann
      • Tatuí, Brazil, 18270-170
        • Not yet recruiting
        • Instituto de Molestias Cardiovasculares de Tatui
        • Principal Investigator:
          • Wladmir Saporito
        • Contact:
          • Phone Number: +551534511300
  • Canada
      • Laval, Canada, H7G 2E6
        • Recruiting
        • THEO Medical Concorde
        • Contact:
          • Phone Number: 438-320-7171
        • Principal Investigator:
          • Mohamed Medhi Khider
      • Lévis, Canada, G6V 0C9
        • Not yet recruiting
        • Alpha Recherche Clinique - Lévis
        • Contact:
          • Phone Number: 418-380-1112
        • Principal Investigator:
          • Steeve Kwan Tat
      • Stoney Creek, Canada, L8J 3W2
        • Recruiting
        • KMH Cardiology Centres - Stoney Creek
        • Contact:
          • Phone Number: 905 855 1860
        • Principal Investigator:
          • Fatima Merali
      • Toronto, Canada, M1B 5N1
        • Recruiting
        • Corcare
        • Principal Investigator:
          • Paul Galiwango
        • Contact:
          • Phone Number: 416-284-4744
      • Toronto, Canada, M5B 1W8
        • Not yet recruiting
        • Unity Health Toronto, St. Michael's Hospital
        • Principal Investigator:
          • Beth Abramson
      • Toronto, Canada, M5G 2C4
        • Not yet recruiting
        • Toronto General Hospital
        • Principal Investigator:
          • Thomas Lindsay
      • Winnipeg, Canada, R3L 1Z5
        • Recruiting
        • Cardio 1 Medical Clinic
        • Principal Investigator:
          • Peiman Malek Marzban
        • Contact:
          • Phone Number: 204-287-5222 ext 104
  • China
      • Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital Capital Medical University
        • Principal Investigator:
          • Lianrui Guo
      • Beijing, China, 100091
        • Recruiting
        • Peking University Third Hospital
        • Principal Investigator:
          • Dan Zhu
        • Contact:
          • Phone Number: 13810103532
      • Beijing, China, 101200
        • Recruiting
        • Beijing Pinggu District Hospital
        • Contact:
          • Phone Number: 13911080328
        • Principal Investigator:
          • yufeng li
      • Chengdu, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Principal Investigator:
          • Limin Tian
      • Guangzhou, China, 510000
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Principal Investigator:
          • Jiyan Chen
      • Harbin, China, 150036
        • Recruiting
        • Heilongjiang Provincial Hospital
        • Principal Investigator:
          • weimin wang
      • Luoyang Shi, China, 471003
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science &Technology
        • Principal Investigator:
          • Hongwei Jiang
        • Contact:
          • Phone Number: 13653880139
      • Nanjing, China, 210029
        • Recruiting
        • Jiangsu Province Hospital
        • Principal Investigator:
          • Xiwei Zhang
      • Nanjing, China, 210006
        • Recruiting
        • Nanjing First Hospital
        • Principal Investigator:
          • Qian Li
      • Nanjing, China, 210012
        • Recruiting
        • Nanjing First Hospital
        • Principal Investigator:
          • Jianping Gu
      • Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital,Fudan University
        • Principal Investigator:
          • Weiguo Fu
      • Shanghai, China, 200023
        • Not yet recruiting
        • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
        • Principal Investigator:
          • Xinwu Lu
      • Tianjin, China, 300052
        • Recruiting
        • Tianjin Medical University General Hospital
        • Principal Investigator:
          • Xiangchen Dai
      • Tianjin, China, 300121
        • Recruiting
        • Tianjin People' s Hospital
        • Principal Investigator:
          • Li Li
      • Wenzhou, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Principal Investigator:
          • Jingyong Huang
      • Xi'an, China, 710077
        • Recruiting
        • The First Affiliated Hospital of Xi'an Medical University
        • Principal Investigator:
          • Ya Li
  • France
      • Angers, France, 49933
        • Not yet recruiting
        • Centre Hospitalier Universitaire d'Angers
        • Contact:
          • Phone Number: +33241353610
        • Principal Investigator:
          • pierre ABRAHAM
      • Chambray-lès-Tours, France, 37170
        • Recruiting
        • CHRU Troussau
        • Contact:
          • Phone Number: +33247479054
        • Principal Investigator:
          • Jean Baptiste de Freminville
      • Lomme, France, 59160
        • Recruiting
        • Hopital Saint Philibert
        • Principal Investigator:
          • Marjolaine TALBOT
      • Nice, France, 06000
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Nice - Hopital Pasteur
        • Principal Investigator:
          • Georges Leftheriotis
        • Contact:
          • Phone Number: 10.00
      • Paris, France, 75015
        • Recruiting
        • Hôpital Européen Georges Pompidou
        • Principal Investigator:
          • Tristan Mirault
      • Paris, France, 75014
        • Not yet recruiting
        • Groupe hospitalier Paris saint Joseph
        • Principal Investigator:
          • Yann Goueffic
      • Rennes, France, 35033
        • Recruiting
        • Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
        • Principal Investigator:
          • Guillaume Mahe
  • India
      • Aligarh, India, 202002
        • Not yet recruiting
        • Jawaharlal Nehru Medical College
        • Contact:
          • Phone Number: 8126320218
        • Principal Investigator:
          • Md. Azharuddin Malik
      • Kolkata, India, 700017
        • Not yet recruiting
        • M. P. Birla Group - Belle Vue Clinic
        • Principal Investigator:
          • Santanu Dutta
      • Kozhikode, India, 673008
        • Not yet recruiting
        • Government Medical College - Kozhikode
        • Principal Investigator:
          • Dr. Rajesh S
      • Nagpur, India, 441108
        • Not yet recruiting
        • All India Institute of Medical Sciences (AIIMS) - Nagpur
        • Contact:
          • Phone Number: 9209197577
        • Principal Investigator:
          • Frankleena Parage
      • Nagpur, India, 440019
        • Not yet recruiting
        • Lata Mangeshkar Hospital - Digdoh
        • Principal Investigator:
          • Hitendra Bhagwatkar
      • Nashik, India, 422005
        • Not yet recruiting
        • Vijan Hospital & Research Centre
        • Principal Investigator:
          • Vikrant Vijan
      • New Delhi, India, 110060
        • Not yet recruiting
        • Sir Ganga Ram Hospital
        • Principal Investigator:
          • Sawhney Jitendra Pal Singh
      • Rishikesh, India, 249203
        • Not yet recruiting
        • All India Institute of Medical Sciences - Rishikesh
        • Contact:
          • Phone Number: 9935615903
        • Principal Investigator:
          • Raja Lahiri
  • Japan
      • Chūō, Japan, 409-3898
        • Not yet recruiting
        • University of Yamanashi Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takamitsu Nakamura
      • Fukuyama, Japan, 721-8511
        • Not yet recruiting
        • Fukuyama City Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Akihiro Oka
      • Hakodate, Japan, 041-8680
        • Not yet recruiting
        • Hakodate Municipal Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • masami shingaki
      • Higashi, Japan, 007-0849
        • Not yet recruiting
        • Medical Corporation Sapporo Heart Center Sapporo Cardio Vascular Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takuya Haraguchi
      • Kanazawa, Japan, 920-8650
        • Not yet recruiting
        • National Hospital Organization Kanazawa Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Fuminori Kasashima
      • Kawasaki, Japan, 215-0026
        • Recruiting
        • Shinyurigaoka General Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • KENJIRO KANEKO
      • Kitakyushu, Japan, 802-8555
        • Not yet recruiting
        • Kokura Memorial Hospital
        • Principal Investigator:
          • Kenji Ando
        • Contact:
          • Phone Number: 81120023812
      • Kobe, Japan, 650-0047
        • Recruiting
        • Kobe City Medical Center General Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yuta Azumi
      • Matsudo, Japan, 271-0077
        • Not yet recruiting
        • Seikeikai Medical Corporation New Tokyo Heart Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Haruhito Yuki
      • Minatoku, Japan, 108-0073
        • Not yet recruiting
        • Tokyo Saiseikai Central Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kenji Suzuki
      • Musashino-shi, Japan, 180-8610
        • Not yet recruiting
        • Japanese Red Cross Musashino Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Toshihiro Nozato
      • Nagoya, Japan, 457-8511
        • Not yet recruiting
        • Koujunkai Daido Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Sumio Morita
      • Naka, Japan, 311-0113
        • Recruiting
        • Nakakinen Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takeshi Osonoi
      • Osaka, Japan, 558-8558
        • Not yet recruiting
        • Osaka General Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Mitsutoshi Asai
      • Osaka, Japan, 540-0006
        • Not yet recruiting
        • National Hospital Organization Osaka National Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yasunori Ueda
      • Osaka, Japan, 553-0003
        • Recruiting
        • Kansai Electric Power Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Shuichiro Kaji
      • Osaka, Japan, 543-0042
        • Recruiting
        • Osaka Keisatsu Hospital
        • Principal Investigator:
          • Osamu Iida
        • Contact:
          • Phone Number: 81120023812
      • Saitama, Japan, 336-8522
        • Recruiting
        • Saitama City Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Atsunori Asami
      • Sapporo, Japan, 062-8618
        • Not yet recruiting
        • Japan Community Healthcare Organization Hokkaido Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masashige Takahashi
      • Shiwa-gun Yahaba-cho, Japan, 028-3695
        • Not yet recruiting
        • Iwate Medical University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yoshihiro Morino
      • Toyonaka, Japan, 560-0055
        • Not yet recruiting
        • Municipal Toyonaka Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hironobu Fujimura
      • Yamagata, Japan, 990-9585
        • Not yet recruiting
        • Yamagata University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masafumi Watanabe
      • Yokohama, Japan, 231-0801
        • Recruiting
        • Yokohama city minato Red Cross Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yasuteru Yamauchi
  • Netherlands
      • Dordrecht, Netherlands, 3318 AT
        • Not yet recruiting
        • Albert Schweitzer Ziekenhuis, Locatie Dordwijk
        • Principal Investigator:
          • Simone Hartong
        • Contact:
          • Phone Number: 0786542686
      • Eindhoven, Netherlands, 5623 EJ
        • Not yet recruiting
        • Catharina Ziekenhuis
        • Contact:
          • Phone Number: 0402397150
        • Principal Investigator:
          • Marc van Sambeek
      • Nijmegen, Netherlands, 6525 GA
        • Not yet recruiting
        • Radboudumc
        • Contact:
          • Phone Number: 31243615333
        • Principal Investigator:
          • Michiel Warle
  • Poland
      • Bydgoszcz, Poland, 85-605
        • Recruiting
        • Centrum Medyczne Intercor Sp. z o.o.
        • Principal Investigator:
          • Grzegorz Grzesk
        • Contact:
          • Phone Number: 48 603 127 021
      • Elblag, Poland, 82-300
        • Recruiting
        • NZOZ Twoje Zdrowie EL Sp. z o. o.
        • Principal Investigator:
          • Waldemar Bieniek
      • Grudziądz, Poland, 86-300
        • Recruiting
        • Przychodnie Grudziądz
        • Principal Investigator:
          • Piotr Kubalski
      • Komorniki, Poland, 62-052
        • Not yet recruiting
        • Centrum Medyczne Komorniki
        • Principal Investigator:
          • Marta Karczewska-Mastalerz
      • Leszno, Poland, 64-100
        • Recruiting
        • Poliklinika Kardiologiczna Serce
        • Principal Investigator:
          • Witold Piotrowski
  • Puerto Rico
      • Ponce, Puerto Rico, 00717
        • Recruiting
        • Research and Cardiovascular Corp.
        • Principal Investigator:
          • Jose Vazquez-Tanus
        • Contact:
          • Phone Number: 787-290-8585
  • Slovakia
      • Bardejov, Slovakia, 085 01
        • Not yet recruiting
        • Alian - Bardejov
        • Contact:
          • Phone Number: 00421905271108
        • Principal Investigator:
          • Andrej Dzupina
      • Žilina, Slovakia, 01001
        • Not yet recruiting
        • MEDIVASA
        • Contact:
          • Phone Number: 421414510419
        • Principal Investigator:
          • Viliam Bugan
  • South Korea
      • Daegu, South Korea, 42472
        • Not yet recruiting
        • Daegu Catholic University Medical Center
        • Principal Investigator:
          • Kihyuk Park
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center
        • Principal Investigator:
          • SEUNG WHAN LEE
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Seung-Kee Min
      • Seoul, South Korea, 02841
        • Not yet recruiting
        • Korea University Anam Hospital
        • Principal Investigator:
          • Cheol Woong Yu
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Principal Investigator:
          • Tsung-Hsien Lin
        • Contact:
          • Phone Number: 886-7-3121101 ext 7741
      • Kaohsiung Niao Sung Dist, Taiwan, 83301
        • Not yet recruiting
        • Chang Gung Memorial Hospital at Kaohsiung
        • Principal Investigator:
          • Shu-Kai Hsueh
      • Taipei, Taiwan, 10002
        • Not yet recruiting
        • National Taiwan University Hospital
        • Contact:
          • Phone Number: 886 972651064
        • Principal Investigator:
          • Hsien-Li Kao
      • Taoyuan District, Taiwan, 333
        • Not yet recruiting
        • Chang Gung Medical Foundation-Linkou Branch
        • Principal Investigator:
          • Pao-Hsien Chu
  • United Kingdom
      • London, United Kingdom, W6 8RF
        • Recruiting
        • Imperial College Healthcare NHS Trust, Charing Cross Hospital
        • Principal Investigator:
          • Alun Davies
      • Plymouth, United Kingdom, Pl6 8DH
        • Not yet recruiting
        • Derriford Hospital
        • Contact:
          • Phone Number: 01752431822
        • Principal Investigator:
          • Devender Mittapalli
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • Not yet recruiting
        • Royal Stoke University Hospital
        • Principal Investigator:
          • Arun Pherwani
      • Swansea, United Kingdom, SA2 8PP
        • Not yet recruiting
        • Swansea University
        • Principal Investigator:
          • Stephen Bain
        • Contact:
          • Phone Number: 07710641345
      • West End, United Kingdom, SO30 3JB
        • Not yet recruiting
        • Moorgreen Hospital
        • Principal Investigator:
          • Sarah Brewster
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Not yet recruiting
        • St. Vincent's Birmingham Hospital
        • Principal Investigator:
          • Christopher DeGroat
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Not yet recruiting
        • Mercy Gilbert Medical Center
        • Contact:
          • Phone Number: 602-214-0886
        • Principal Investigator:
          • Nabil Dib, MD, Msc,
      • Surprise, Arizona, United States, 85378
        • Recruiting
        • Axsendo Clinical Research - Peak Heart & Vascular - Surprise
        • Contact:
          • Phone Number: 844-290-2273
        • Principal Investigator:
          • Frank Lovecchio
      • Tucson, Arizona, United States, 85715
        • Recruiting
        • Del Sol Research Management, LLC
        • Contact:
          • Phone Number: 520-257-3881
        • Principal Investigator:
          • Carl Diener
    • California
      • Northridge, California, United States, 91325
        • Recruiting
        • Valley Clinical Trials, Inc.
        • Principal Investigator:
          • Christopher Chow
        • Contact:
          • Phone Number: 818-280-4220
      • Redding, California, United States, 96001
        • Recruiting
        • The Cardiovascular Center
        • Contact:
          • Phone Number: 281-944-3610
        • Principal Investigator:
          • Mohamed Hussein Khan, MD
      • Van Nuys, California, United States, 91405
        • Not yet recruiting
        • InvivoCure
        • Principal Investigator:
          • Rodney Samaan
        • Contact:
          • Phone Number: 859-509-0084
      • West Hills, California, United States, 91307
        • Recruiting
        • Interventional Cardiology Medical Group
        • Principal Investigator:
          • Farhad Rafii
        • Contact:
          • Phone Number: 818-702-8800
    • Florida
      • Leesburg, Florida, United States, 34748
        • Recruiting
        • Lakeview Institute of Clinical Research
        • Contact:
          • Phone Number: 352-782-0606
        • Principal Investigator:
          • Khai Chang
      • Miami Lakes, Florida, United States, 33016-1518
        • Recruiting
        • Floridian Clinical Research, LLC
        • Contact:
          • Phone Number: 305-330-9977
        • Principal Investigator:
          • Gilberto Concepcion
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Inpatient Research Clinic
        • Principal Investigator:
          • Alexis Gutierrez
        • Contact:
          • Phone Number: 786-502-4303
      • Saint Augustine, Florida, United States, 32086
        • Recruiting
        • St Johns Center for Clinical Research
        • Contact:
          • Phone Number: 904-209-0043
        • Principal Investigator:
          • Ameeth Verde
    • Indiana
      • Hammond, Indiana, United States, 46324
        • Recruiting
        • ASHA Clinical Research - Munster, LLC
        • Principal Investigator:
          • Mohan Kesani
        • Contact:
          • Phone Number: 219-803-6649
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health Methodist Hospital
        • Principal Investigator:
          • Rolf Kreutz
      • Newburgh, Indiana, United States, 47630
        • Recruiting
        • Deaconess Clinic- Gateway
        • Contact:
          • Phone Number: 812-490-4505
        • Principal Investigator:
          • Sridhar Banuru
    • Maryland
      • Bowie, Maryland, United States, 20715
        • Recruiting
        • Flourish Research - Bowie
        • Principal Investigator:
          • Sara Collins
        • Contact:
          • Phone Number: 410-824-1341
    • Michigan
      • Troy, Michigan, United States, 48098
        • Recruiting
        • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
        • Contact:
          • Phone Number: 248-312-0025
        • Principal Investigator:
          • Neil Fraser
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Recruiting
        • Capital Area Research, LLC
        • Contact:
          • Phone Number: 717-441-1725
        • Principal Investigator:
          • Venkatesh Nadar
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Not yet recruiting
        • The Jackson Clinic
        • Contact:
          • Phone Number: 731-660-8396
        • Principal Investigator:
          • Antwan Robinson
      • Jefferson City, Tennessee, United States, 37760
        • Recruiting
        • East Coast Institute for Research - Jefferson City
        • Principal Investigator:
          • Pragnesh Patel
    • Texas
      • Houston, Texas, United States, 77084
        • Recruiting
        • Biopharma Informatic, LLC
        • Contact:
          • Phone Number: 281-944-3610
        • Principal Investigator:
          • Imran Ahmed Dar, MD
      • Houston, Texas, United States, 77089
        • Recruiting
        • Research Physicians Network, LLC
        • Contact:
          • Phone Number: 832-847-1724
        • Principal Investigator:
          • Nadish Garg, MD
      • Sherman, Texas, United States, 75090
        • Recruiting
        • Sherman Clinical Research
        • Contact:
          • Phone Number: 903-771-4093
        • Principal Investigator:
          • Tariq Yousuf
      • Waco, Texas, United States, 76712
        • Recruiting
        • NextStage Clinical Research - Waco
        • Principal Investigator:
          • Donald Cross
    • Utah
      • Clinton, Utah, United States, 84015
        • Recruiting
        • Alpine Research Organization
        • Principal Investigator:
          • Justin Mansfield
        • Contact:
          • Phone Number: 801-791-2206
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Recruiting
        • Stroobants Cardiovascular Center
        • Principal Investigator:
          • Supawat Ratanapo
      • Richmond, Virginia, United States, 23226
        • Recruiting
        • Clinical Research Partners, LLC
        • Contact:
          • Phone Number: 804-477-3045
        • Principal Investigator:
          • Robert Call
      • Virginia Beach, Virginia, United States, 23454
        • Recruiting
        • Gershon Pain Specialists
        • Contact:
          • Phone Number: 757-496-2050
        • Principal Investigator:
          • Steven Gershon
    • Washington
      • Lynnwood, Washington, United States, 98036
        • Recruiting
        • ERA Health Research - CardioNow - Lynnwood
        • Contact:
          • Phone Number: 425-869-6828
        • Principal Investigator:
          • Mahesh Mulumudi
      • Redmond, Washington, United States, 98052
        • Recruiting
        • Eastside Research Associates
        • Contact:
          • Phone Number: 425-869-6828
        • Principal Investigator:
          • Christopher Price

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo orally
Drug: Placebo
Administered orally
Experimental: Orforglipron
Participants will receive orforglipron orally
Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change from Baseline in Maximum Walking Distance
Time Frame: Baseline, Week 52
On a constant load treadmill test
Baseline, Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change from Baseline in Pain Free Walking Distance
Time Frame: Baseline, Week 52
On a constant load treadmill test
Baseline, Week 52
Change from Baseline in Vascular Quality of Life (VascuQoL-6) Questionnaire Score
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in 6 Minute Walk Test Distance (meters)
Time Frame: Baseline, Week 52
Baseline, Week 52
Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Systolic Blood Pressure (mmHg)
Time Frame: Baseline, Week 52
Baseline, Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

October 30, 2025

First Submitted That Met QC Criteria

October 30, 2025

First Posted (Actual)

November 3, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27632
  • 2025-523283-21-00 (Ctis)
  • J2A-MC-GZPR (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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