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Recruiting Phase 3 NCT07223593

Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

Phase 3 – large-scale trial before approval
Conditions: Peripheral Arterial Disease

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 16
Argentina (1)
CIPREC
Buenos Aires
NOT_YET_RECRUITING
Australia (1)
Box Hill Hospital
Box Hill
Brazil (1)
Centro de Pesquisa Clinica do Coracao
Aracaju
NOT_YET_RECRUITING
Canada (1)
THEO Medical Concorde
Laval
China (1)
Xuanwu Hospital Capital Medical University
Beijing
France (1)
Centre Hospitalier Universitaire d'Angers
Angers
NOT_YET_RECRUITING
India (1)
Jawaharlal Nehru Medical College
Aligarh
NOT_YET_RECRUITING
Japan (1)
University of Yamanashi Hospital
Chūō
NOT_YET_RECRUITING
Netherlands (1)
Albert Schweitzer Ziekenhuis, locatie Dordwijk
Dordrecht
NOT_YET_RECRUITING
Poland (1)
Centrum Medyczne INTERCOR Sp. z o.o.
Bydgoszcz
Puerto Rico (1)
Research and Cardiovascular Corp.
Ponce
Slovakia (1)
Alian - Bardejov
Bardejov
NOT_YET_RECRUITING
South Korea (1)
Daegu Catholic University Medical Center
Daegu
NOT_YET_RECRUITING
Taiwan (1)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
United Kingdom (1)
Imperial College Healthcare NHS Trust, Charing Cross Hospital
London
United States (1)
St. Vincent's Birmingham Hospital
Birmingham , Alabama
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
31.10.2025
Completion date
01.06.2028
Registry ID
NCT07223593
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.