Clinical trial
Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease
Recruiting now · Phase 3 · 5 countries · Registry ID NCT07223593
Recruiting nowPhase 3Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionPeripheral Arterial Disease
Full registry criteria
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
Treatments and study arms
Orforglipron
Drug
Administered orally
Placebo
Drug
Administered orally
Primary outcomes
Percent Change from Baseline in Maximum Walking DistanceBaseline, Week 52
On a constant load treadmill test
Study locations
161 locations were listed when this page was built. The first 40 are shown.
CEMEDIC🇦🇷 Buenos Aires, Argentina
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Claudio MajulPrincipal Investigator
CIPREC🇦🇷 Buenos Aires, Argentina
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Fernando GuerlloyPrincipal Investigator
CIPREC🇦🇷 Buenos Aires, Argentina
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Angela Romero ZarantePrincipal Investigator
Sanatorio Finochietto🇦🇷 Buenos Aires, Argentina
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Nicolás GonzalezPrincipal Investigator
Instituto de Investigaciones Clínicas Córdoba🇦🇷 Córdoba, Argentina
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Ines BartolacciPrincipal Investigator
MICA - Medicina e Investigación Cardiometabólica🇦🇷 Del Viso, Argentina
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Micaela MiradaPrincipal Investigator
Centro de Investigaciones Clínicas Baigorria🇦🇷 Granadero Baigorria, Argentina
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Juan DominguezPrincipal Investigator
DIM Clínica Privada🇦🇷 Ramos Mejía, Argentina
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Oscar MontañaPrincipal Investigator
Fundacion Estudios Clinicos🇦🇷 Rosario, Argentina
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María SchiavoniPrincipal Investigator
INECO Neurociencias Oroño🇦🇷 Rosario, Argentina
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Dana MirallesPrincipal Investigator
Instituto de Investigaciones Clinicas Rosario🇦🇷 Rosario, Argentina
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Carolina ChacónPrincipal Investigator
Go Centro Medico San Nicolás🇦🇷 San Nicolás, Argentina
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Paulina LanchiottiPrincipal Investigator
Centro de Salud e Investigaciones Médicas🇦🇷 Santa Rosa, Argentina
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Marcos MayerPrincipal Investigator
Core Research Group🇦🇺 Brisbane, Australia
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David ColquhounPrincipal Investigator
Heart of Australia🇦🇺 Brisbane, Australia
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Rolf GomesPrincipal Investigator
University of the Sunshine Coast (UniSC) Clinical Trials - Meadowbrook🇦🇺 Meadowbrook, Australia
Ivan LimPrincipal Investigator
Gold Coast University Hospital🇦🇺 Southport, Australia
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Jessica TriayPrincipal Investigator
Centro de Pesquisa Clinica do Coracao🇧🇷 Aracaju, Brazil
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FÁBIO SILVEIRAPrincipal Investigator
Hospital Universitário João de Barros Barreto🇧🇷 Belém, Brazil
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Joao FelicioPrincipal Investigator
Centro de Pesquisa Sao Lucas🇧🇷 Campinas, Brazil
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Danilo Villagelin NetoPrincipal Investigator
Instituto de Pesquisa clinica de Campinas🇧🇷 Campinas, Brazil
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Jose SaraivaPrincipal Investigator
Universidade Federal de Goias🇧🇷 Goiânia, Brazil
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Aguinaldo FreitasPrincipal Investigator
Hospital de Clinicas de Porto Alegre🇧🇷 Porto Alegre, Brazil
Adamastor PereiraPrincipal Investigator
Centro Avançado De Pesquisa, Estudos E Diagnóstico (CAPED) - Centro Médico RibeirãoShopping🇧🇷 Ribeirão Preto, Brazil
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Pedro SchwartzmannPrincipal Investigator
Instituto de Molestias Cardiovasculares de Tatui🇧🇷 Tatuí, Brazil
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Wladmir SaporitoPrincipal Investigator
THEO Medical Concorde🇨🇦 Laval, Canada
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Mohamed Medhi KhiderPrincipal Investigator
Alpha Recherche Clinique - Lévis🇨🇦 Lévis, Canada
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Steeve Kwan TatPrincipal Investigator
KMH Cardiology Centres - Stoney Creek🇨🇦 Stoney Creek, Canada
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Fatima MeraliPrincipal Investigator
Corcare🇨🇦 Toronto, Canada
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Paul GaliwangoPrincipal Investigator
Unity Health Toronto, St. Michael's Hospital🇨🇦 Toronto, Canada
Beth AbramsonPrincipal Investigator
Cardio 1 Medical Clinic🇨🇦 Winnipeg, Canada
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Peiman Malek MarzbanPrincipal Investigator
Beijing Pinggu District Hospital🇨🇳 Beijing, China
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yufeng liPrincipal Investigator
Peking University Third Hospital🇨🇳 Beijing, China
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Dan ZhuPrincipal Investigator
Xuanwu Hospital Capital Medical University🇨🇳 Beijing, China
Lianrui GuoPrincipal Investigator