Actively Recruiting
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
Led by Eli Lilly and Company · Updated on 2026-06-04
1205
Participants Needed
138
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects and safety of orforglipron, taken once daily, in adults with Fontaine II peripheral arterial disease (PAD) who experience symptoms like intermittent claudication. This Phase 3 trial aims to evaluate how orforglipron influences walking ability and quality of life in participants with this condition. The study is sponsored by Eli Lilly and Company and will last about 58 weeks for each participant. Participants will be randomly assigned to receive either orforglipron or a placebo, both taken orally once daily. The study uses a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo. Key assessments will occur at the start and at week 52, measuring walking distance and other health indicators. The trial includes careful monitoring of safety and effectiveness during the treatment period. During the study, participants will undergo tests like the maximum walking distance and pain-free walking distance assessments, quality of life questionnaires, a 6-minute walk test, and blood tests including high-sensitivity C-reactive protein and blood pressure measurements. These evaluations help researchers understand the impact of the drug on PAD symptoms. Participants’ progress and safety will be followed closely throughout the nearly one-year study period.
CONDITIONS
Brief Title
Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have symptomatic PAD with intermittent claudication of Fontaine Stage II
- Have an Ankle Brachial Index (ABI) of 0.9 or less
- Be aged 18 years or older
You will not qualify if you...
- 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 screening or planning to undergo peripheral revascularization during the trial
- Had stroke, transient ischemic attack, myocardial infarction, coronary or carotid revascularization, or hospitalization for unstable angina within 60 days prior to screening
- Have heart failure classified as New York Heart Association class III - IV
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 52 weeks
Participants receive daily oral doses of either Orforglipron or placebo to assess efficacy and safety in managing Peripheral Artery Disease.
Multiple visits during the 52 weeks of treatment
Trial Site Locations
Total: 138 locations
1
St. Vincent's Birmingham Hospital
Birmingham, Alabama, United States, 35205
Not Yet Recruiting
2
Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297
Actively Recruiting
3
Emvera Health at Peak Heart & Vascular Surprise
Surprise, Arizona, United States, 85378
Actively Recruiting
4
Del Sol Research Management, LLC
Tucson, Arizona, United States, 85715
Actively Recruiting
5
Valley Clinical Trials, Inc.
Northridge, California, United States, 91325
Actively Recruiting
6
The Cardiovascular Center
Redding, California, United States, 96001
Actively Recruiting
7
InvivoCure
Van Nuys, California, United States, 91405
Actively Recruiting
8
Interventional Cardiology Medical Group
West Hills, California, United States, 91307
Actively Recruiting
9
Lakeview Institute of Clinical Research
Leesburg, Florida, United States, 34748
Actively Recruiting
10
Inpatient Research Clinic
Miami Lakes, Florida, United States, 33014
Actively Recruiting
11
Floridian Clinical Research, LLC
Miami Lakes, Florida, United States, 33016-1518
Actively Recruiting
12
St Johns Center for Clinical Research
Saint Augustine, Florida, United States, 32086
Actively Recruiting
13
ASHA Clinical Research - Munster, LLC
Hammond, Indiana, United States, 46324
Actively Recruiting
14
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
15
Deaconess Clinic- Gateway
Newburgh, Indiana, United States, 47630
Actively Recruiting
16
Flourish Research - Bowie
Bowie, Maryland, United States, 20715
Actively Recruiting
17
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States, 48098
Actively Recruiting
18
Capital Area Research, LLC
Camp Hill, Pennsylvania, United States, 17011
Actively Recruiting
19
The Jackson Clinic
Jackson, Tennessee, United States, 38305
Actively Recruiting
20
East Coast Institute for Research - Jefferson City
Jefferson City, Tennessee, United States, 37760
Actively Recruiting
21
Biopharma Informatic, LLC
Houston, Texas, United States, 77084
Actively Recruiting
22
Research Physicians Network, LLC
Houston, Texas, United States, 77089
Actively Recruiting
23
Sherman Clinical Research
Sherman, Texas, United States, 75090
Actively Recruiting
24
NextStage Clinical Research - Waco
Waco, Texas, United States, 76712
Actively Recruiting
25
Alpine Research Organization
Clinton, Utah, United States, 84015
Actively Recruiting
26
Stroobants Cardiovascular Center
Lynchburg, Virginia, United States, 24501
Actively Recruiting
27
Clinical Research Partners, LLC
Richmond, Virginia, United States, 23226
Actively Recruiting
28
Gershon Pain Specialists
Virginia Beach, Virginia, United States, 23454
Actively Recruiting
29
ERA Health Research - CardioNow - Lynnwood
Lynnwood, Washington, United States, 98036
Actively Recruiting
30
Eastside Research Associates
Redmond, Washington, United States, 98052
Actively Recruiting
31
CIPREC
Buenos Aires, Argentina, C1119ACN
Actively Recruiting
32
Sanatorio Finochietto
Buenos Aires, Argentina, C1187AAN
Actively Recruiting
33
CEMEDIC
Buenos Aires, Argentina, C1407GTN
Actively Recruiting
34
Instituto de Investigaciones Clínicas Córdoba
Córdoba, Argentina, 5000
Actively Recruiting
35
DIM Clínica Privada
Ramos Mejía, Argentina, B1704ETD
Actively Recruiting
36
INECO Neurociencias Oroño
Rosario, Argentina, 2000
Actively Recruiting
37
Instituto de Investigaciones Clinicas Rosario
Rosario, Argentina, S2000CVD
Actively Recruiting
38
Go Centro Medico San Nicolás
San Nicolás, Argentina, 2900
Actively Recruiting
39
Centro de Salud e Investigaciones Médicas
Santa Rosa, Argentina, L6300
Actively Recruiting
40
Box Hill Hospital
Box Hill, Australia, 3128
Actively Recruiting
41
Core Research Group
Brisbane, Australia, 4064
Actively Recruiting
42
Canberra Hospital
Canberra, Australia, 2605
Actively Recruiting
43
University of the Sunshine Coast (UniSC) Clinical Trials - Meadowbrook
Meadowbrook, Australia, 4131
Actively Recruiting
44
Royal Perth Hospital
Perth, Australia, 6000
Actively Recruiting
45
Gold Coast University Hospital
Southport, Australia, 4215
Not Yet Recruiting
46
Centro de Pesquisa Clinica do Coracao
Aracaju, Brazil, 49055-530
Not Yet Recruiting
47
Hospital Universitário João de Barros Barreto
Belém, Brazil, 66073-000
Not Yet Recruiting
48
Instituto de Pesquisa clinica de Campinas
Campinas, Brazil, 13060-080
Not Yet Recruiting
49
Centro de Pesquisa Sao Lucas
Campinas, Brazil, 13060-803
Not Yet Recruiting
50
Universidade Federal de Goias
Goiânia, Brazil, 74605-020
Not Yet Recruiting
51
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil, 90035-903
Not Yet Recruiting
52
Centro Avançado De Pesquisa, Estudos E Diagnóstico (CAPED) - Centro Médico RibeirãoShopping
Ribeirão Preto, Brazil, 14026-020
Not Yet Recruiting
53
Instituto de Molestias Cardiovasculares de Tatui
Tatuí, Brazil, 18270-170
Not Yet Recruiting
54
THEO Medical Concorde
Laval, Canada, H7G 2E6
Actively Recruiting
55
Alpha Recherche Clinique - Lévis
Lévis, Canada, G6V 0C9
Actively Recruiting
56
KMH Cardiology Centres - Stoney Creek
Stoney Creek, Canada, L8J 3W2
Actively Recruiting
57
Corcare
Toronto, Canada, M1B 5N1
Actively Recruiting
58
Unity Health Toronto, St. Michael's Hospital
Toronto, Canada, M5B 1W8
Not Yet Recruiting
59
Toronto General Hospital
Toronto, Canada, M5G 2C4
Not Yet Recruiting
60
Cardio 1 Medical Clinic
Winnipeg, Canada, R3L 1Z5
Actively Recruiting
61
Xuanwu Hospital Capital Medical University
Beijing, China, 100053
Actively Recruiting
62
Peking University Third Hospital
Beijing, China, 100091
Actively Recruiting
63
Beijing Pinggu District Hospital
Beijing, China, 101200
Actively Recruiting
64
Sichuan Provincial People's Hospital
Chengdu, China, 610072
Actively Recruiting
65
Guangdong Provincial People's Hospital
Guangzhou, China, 510000
Actively Recruiting
66
Heilongjiang Provincial Hospital
Harbin, China, 150036
Actively Recruiting
67
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, China, 471003
Actively Recruiting
68
Nanjing First Hospital
Nanjing, China, 210006
Actively Recruiting
69
Nanjing First Hospital
Nanjing, China, 210012
Actively Recruiting
70
Jiangsu Province Hospital
Nanjing, China, 210029
Actively Recruiting
71
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200023
Actively Recruiting
72
Zhongshan Hospital,Fudan University
Shanghai, China, 200032
Actively Recruiting
73
Tianjin Medical University General Hospital
Tianjin, China, 300052
Actively Recruiting
74
Tianjin People' s Hospital
Tianjin, China, 300121
Actively Recruiting
75
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China, 325000
Actively Recruiting
76
The First Affiliated Hospital of Xi'an Medical University
Xi'an, China, 710077
Actively Recruiting
77
Centre Hospitalier Universitaire d'Angers
Angers, France, 49933
Not Yet Recruiting
78
CHRU Troussau
Chambray-lès-Tours, France, 37170
Actively Recruiting
79
Hôpital Saint Philibert
Lomme, France, 59160
Actively Recruiting
80
Centre Hospitalier Universitaire de Nice - Hopital Pasteur
Nice, France, 06000
Actively Recruiting
81
Groupe hospitalier Paris saint Joseph
Paris, France, 75014
Actively Recruiting
82
Hôpital Européen Georges Pompidou
Paris, France, 75015
Actively Recruiting
83
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, France, 35033
Actively Recruiting
84
Jawaharlal Nehru Medical College
Aligarh, India, 202002
Not Yet Recruiting
85
M. P. Birla Group - Belle Vue Clinic
Kolkata, India, 700017
Not Yet Recruiting
86
Government Medical College - Kozhikode
Kozhikode, India, 673008
Not Yet Recruiting
87
Lata Mangeshkar Hospital - Digdoh
Nagpur, India, 440019
Not Yet Recruiting
88
All India Institute of Medical Sciences (AIIMS) - Nagpur
Nagpur, India, 441108
Not Yet Recruiting
89
Vijan Hospital & Research Centre
Nashik, India, 422005
Not Yet Recruiting
90
Sir Ganga Ram Hospital
New Delhi, India, 110060
Not Yet Recruiting
91
All India Institute of Medical Sciences - Rishikesh
Rishikesh, India, 249203
Not Yet Recruiting
92
University of Yamanashi Hospital
Chūō, Japan, 409-3898
Actively Recruiting
93
Fukuyama City Hospital
Fukuyama, Japan, 721-8511
Actively Recruiting
94
Hakodate Municipal Hospital
Hakodate, Japan, 041-8680
Actively Recruiting
95
Medical Corporation Sapporo Heart Center Sapporo Cardio Vascular Clinic
Higashi, Japan, 007-0849
Actively Recruiting
96
National Hospital Organization Kanazawa Medical Center
Kanazawa, Japan, 920-8650
Actively Recruiting
97
Shinyurigaoka General Hospital
Kawasaki, Japan, 215-0026
Actively Recruiting
98
Kokura Memorial Hospital
Kitakyushu, Japan, 802-8555
Actively Recruiting
99
Kobe City Medical Center General Hospital
Kobe, Japan, 650-0047
Actively Recruiting
100
Seikeikai Medical Corporation New Tokyo Heart Clinic
Matsudo, Japan, 271-0077
Actively Recruiting
101
Tokyo Saiseikai Central Hospital
Minatoku, Japan, 108-0073
Not Yet Recruiting
102
Japanese Red Cross Musashino Hospital
Musashino-shi, Japan, 180-8610
Actively Recruiting
103
Koujunkai Daido Clinic
Nagoya, Japan, 457-8511
Not Yet Recruiting
104
Nakakinen clinic
Naka, Japan, 311-0113
Actively Recruiting
105
National Hospital Organization Osaka National Hospital
Osaka, Japan, 540-0006
Actively Recruiting
106
Osaka Keisatsu Hospital
Osaka, Japan, 543-0042
Actively Recruiting
107
Kansai Electric Power Hospital
Osaka, Japan, 553-0003
Actively Recruiting
108
Osaka General Medical Center
Osaka, Japan, 558-8558
Actively Recruiting
109
Saitama City Hospital
Saitama, Japan, 336-8522
Actively Recruiting
110
Japan Community Healthcare Organization Hokkaido Hospital
Sapporo, Japan, 062-8618
Actively Recruiting
111
Iwate Medical University Hospital
Shiwa-gun Yahaba-cho, Japan, 028-3695
Actively Recruiting
112
Municipal Toyonaka Hospital
Toyonaka, Japan, 560-0055
Actively Recruiting
113
Yamagata University Hospital
Yamagata, Japan, 990-9585
Actively Recruiting
114
Yokohama City Minato Red Cross Hospital
Yokohama, Japan, 231-0801
Actively Recruiting
115
Albert Schweitzer Ziekenhuis, locatie Dordwijk
Dordrecht, Netherlands, 3318 AT
Not Yet Recruiting
116
Catharina Ziekenhuis
Eindhoven, Netherlands, 5623 EJ
Not Yet Recruiting
117
Radboudumc
Nijmegen, Netherlands, 6525 GA
Not Yet Recruiting
118
Centrum Medyczne INTERCOR Sp. z o.o.
Bydgoszcz, Poland, 85-605
Actively Recruiting
119
NZOZ Twoje Zdrowie EL Sp. z o. o.
Elblag, Poland, 82-300
Actively Recruiting
120
Przychodnie Grudziądz
Grudziądz, Poland, 86-300
Actively Recruiting
121
Centrum Medyczne Komorniki
Komorniki, Poland, 62-052
Actively Recruiting
122
Poliklinika Kardiologiczna Serce
Leszno, Poland, 64-100
Actively Recruiting
123
Research and Cardiovascular Corp.
Ponce, Puerto Rico, 00717
Actively Recruiting
124
Alian - Bardejov
Bardejov, Slovakia, 085 01
Not Yet Recruiting
125
MEDIVASA
Žilina, Slovakia, 01001
Actively Recruiting
126
Daegu Catholic University Medical Center
Daegu, South Korea, 42472
Actively Recruiting
127
Korea University Anam Hospital
Seoul, South Korea, 02841
Not Yet Recruiting
128
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
129
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
130
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
Actively Recruiting
131
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Taiwan, 83301
Actively Recruiting
132
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
133
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan, 333
Actively Recruiting
134
Imperial College Healthcare NHS Trust, Charing Cross Hospital
London, United Kingdom, W6 8RF
Actively Recruiting
135
Derriford Hospital
Plymouth, United Kingdom, Pl6 8DH
Actively Recruiting
136
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom, ST4 6QG
Not Yet Recruiting
137
Swansea University
Swansea, United Kingdom, SA2 8PP
Not Yet Recruiting
138
Moorgreen Hospital
West End, United Kingdom, SO30 3JB
Not Yet Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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