Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease
ATTAIN-PAD
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
3 other identifiers
interventional
1,205
16 countries
138
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2025
Typical duration for phase_3
138 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2025
CompletedStudy Start
First participant enrolled
October 31, 2025
CompletedFirst Posted
Study publicly available on registry
November 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
June 4, 2026
June 1, 2026
2.6 years
October 30, 2025
June 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change from Baseline in Maximum Walking Distance
On a constant load treadmill test
Baseline, Week 52
Secondary Outcomes (5)
Percent Change from Baseline in Pain Free Walking Distance
Baseline, Week 52
Change from Baseline in Vascular Quality of Life (VascuQoL-6) Questionnaire Score
Baseline, Week 52
Change from Baseline in 6 Minute Walk Test Distance (meters)
Baseline, Week 52
Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Baseline, Week 52
Change from Baseline in Systolic Blood Pressure (mmHg)
Baseline, Week 52
Study Arms (2)
Orforglipron
EXPERIMENTALParticipants will receive orforglipron orally
Placebo
PLACEBO COMPARATORParticipants will receive placebo orally
Interventions
Eligibility Criteria
You may qualify if:
- Have symptomatic PAD with intermittent claudication of Fontaine Stage II
- Have an Ankle Brachial Index (ABI) of 0.9 or less
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (138)
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
Valley Clinical Trials, Inc.
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
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, C1119ACN, Argentina
Sanatorio Finochietto
Buenos Aires, C1187AAN, Argentina
CEMEDIC
Buenos Aires, C1407GTN, Argentina
Instituto de Investigaciones Clínicas Córdoba
Córdoba, 5000, Argentina
DIM Clínica Privada
Ramos Mejía, B1704ETD, 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
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
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
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
M. P. Birla Group - Belle Vue Clinic
Kolkata, 700017, India
Government Medical College - Kozhikode
Kozhikode, 673008, 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
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
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
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
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
Research and Cardiovascular Corp.
Ponce, 00717, Puerto Rico
Alian - Bardejov
Bardejov, 085 01, Slovakia
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2025
First Posted
November 3, 2025
Study Start
October 31, 2025
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
June 4, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.