Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Orforglipron, Placebo.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Brazil, Canada +11
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
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.
Interventions
- Drug Orforglipron
Administered orally - Drug Placebo
Administered orally
Primary outcome measures
- Percent Change from Baseline in Maximum Walking Distance [Time frame: Baseline, Week 52]
Secondary outcome measures (5)
- Percent Change from Baseline in Pain Free Walking Distance [Time frame: Baseline, Week 52]
- Change from Baseline in Vascular Quality of Life (VascuQoL-6) Questionnaire Score [Time frame: Baseline, Week 52]
- Change from Baseline in 6 Minute Walk Test Distance (meters) [Time frame: Baseline, Week 52]
- Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) [Time frame: Baseline, Week 52]
- Change from Baseline in Systolic Blood Pressure (mmHg) [Time frame: Baseline, Week 52]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 34 centers
- St. Vincent's Birmingham Hospital — Birmingham
- Mercy Gilbert Medical Center — Gilbert
- Emvera Health at Peak Heart & Vascular Surprise — Surprise
- Del Sol Research Management, LLC — Tucson
- Angel City Research Inc. — Los Angeles
- Valley Clinical Trials, LLC dba Flourish Research — Northridge
- The Cardiovascular Center — Redding
- InvivoCure — Van Nuys
- … and 26 more centers
Japan · 26 centers
Center list to be confirmed — check the primary protocol.
China · 18 centers
- Xuanwu Hospital Capital Medical University — Beijing
- Peking University Third Hospital — Beijing
- Beijing Pinggu District Hospital — Beijing
- Sichuan Provincial People's Hospital — Chengdu
- Guangdong Provincial People's Hospital — Guangzhou
- The Fourth Affiliated Hospital of Harbin Medical University — Harbin
- Heilongjiang Provincial Hospital — Harbin
- The First Affiliated Hospital of Henan University of Science &Technology — Luoyang Shi
- … and 10 more centers
Argentina · 13 centers
- CIPREC — Buenos Aires
- CIPREC — Buenos Aires
- Sanatorio Finochietto — Buenos Aires
- CEMEDIC — Buenos Aires
- Instituto de Investigaciones Clínicas Córdoba — Córdoba
- MICA - Medicina e Investigación Cardiometabólica — Del Viso
- Centro de Investigaciones Clínicas Baigorria — Granadero Baigorria
- DIM Clínica Privada — Ramos Mejía
- … and 5 more centers
India · 11 centers
Center list to be confirmed — check the primary protocol.
Australia · 8 centers
- Box Hill Hospital — Box Hill
- Core Research Group — Brisbane
- Heart of Australia — Brisbane
- Canberra Hospital — Canberra
- University of the Sunshine Coast (UniSC) Clinical Trials - Meadowbrook — Meadowbrook
- Royal Perth Hospital — Perth
- Gold Coast University Hospital — Southport
- Royal North Shore Hospital — St Leonards
Brazil · 8 centers
- Centro de Pesquisa Clinica do Coracao — Aracaju
- Hospital Universitário João de Barros Barreto — Belém
- Instituto de Pesquisa clinica de Campinas — Campinas
- Centro de Pesquisa Sao Lucas — Campinas
- Universidade Federal de Goias — Goiânia
- Hospital de Clinicas de Porto Alegre — Porto Alegre
- Centro Avançado De Pesquisa, Estudos E Diagnóstico (CAPED) - Centro Médico RibeirãoShoppin — Ribeirão Preto
- Instituto de Molestias Cardiovasculares de Tatui — Tatuí
Canada · 7 centers
- THEO Medical Concorde — Laval
- Alpha Recherche Clinique - Lévis — Lévis
- KMH Cardiology Centres - Stoney Creek — Stoney Creek
- Corcare — Toronto
- Unity Health Toronto, St. Michael's Hospital — Toronto
- Toronto General Hospital — Toronto
- Cardio 1 Medical Clinic — Winnipeg
France · 7 centers
Center list to be confirmed — check the primary protocol.
Poland · 7 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 5 centers
Center list to be confirmed — check the primary protocol.
South Korea · 4 centers
Center list to be confirmed — check the primary protocol.
Taiwan · 4 centers
Center list to be confirmed — check the primary protocol.
Netherlands · 3 centers
Center list to be confirmed — check the primary protocol.
Puerto Rico · 1 center
Center list to be confirmed — check the primary protocol.
Slovakia · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07223593 · 27632 · 2025-523283-21-00 · J2A-MC-GZPR