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Studies

Interventional Recruiting Phase 3

NCT07223593 on ClinicalTrials.gov

Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

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

  • Sponsor: Eli Lilly (Group)
  • Enrollment: 1205 (Estimated)
  • Study start: 2025-10-31 (Actual)
  • Primary completion: 2028-06-01 (Estimated)
  • Study completion: 2028-06-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Double (Participant, Investigator)
  • PrimaryPurpose: Treatment

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.

Conditions

  • Peripheral Arterial Disease

Intervention / Treatment

  • Drug: Orforglipron
  • Drug: Placebo

Primary Outcome Measures

  • Percent Change from Baseline in Maximum Walking Distance (Baseline, Week 52)
    On a constant load treadmill test

Countries

Argentina, Australia, Brazil, Canada, China, France, Greece, India, Israel, Japan, Netherlands, Poland, Puerto Rico, Slovakia, South Korea, Taiwan, United Kingdom, United States

Locations and Investigators

  • St. Vincent's Birmingham Hospital, Birmingham, United States (Recruiting)
    • Christopher DeGroat (Principal Investigator)
  • Mercy Gilbert Medical Center, Gilbert, United States (Recruiting)
    • Nabil Dib, MD, Msc, (Principal Investigator)
  • Emvera Health at Peak Heart & Vascular Surprise, Surprise, United States (Not yet recruiting)
    • Frank Lovecchio (Principal Investigator)
  • Del Sol Research Management, LLC, Tucson, United States (Recruiting)
    • Carl Diener (Principal Investigator)
  • Angel City Research Inc., Los Angeles, United States (Not yet recruiting)
    • Parham Parto (Principal Investigator)
  • Valley Clinical Trials, LLC dba Flourish Research, Northridge, United States (Recruiting)
    • Christopher Chow (Principal Investigator)
  • The Cardiovascular Center, Redding, United States (Recruiting)
    • Mohamed Hussein Khan, MD (Principal Investigator)
  • InvivoCure, Van Nuys, United States (Recruiting)
    • Rodney Samaan (Principal Investigator)
  • Interventional Cardiology Medical Group, West Hills, United States (Recruiting)
    • Farhad Rafii (Principal Investigator)
  • Rocky Mountain Regional VA Medical Center, Aurora, United States (Not yet recruiting)
    • David Saxon (Principal Investigator)
  • Lakeview Institute of Clinical Research, Leesburg, United States (Recruiting)
    • Khai Chang (Principal Investigator)
  • Inpatient Research Clinic, Miami Lakes, United States (Recruiting)
    • Alexis Gutierrez (Principal Investigator)
  • Floridian Clinical Research, LLC, Miami Lakes, United States (Recruiting)
    • Gilberto Concepcion (Principal Investigator)
  • St Johns Center for Clinical Research, Saint Augustine, United States (Recruiting)
    • Ameeth Vedre (Principal Investigator)
  • Guardian Research Organization, LLC, Winter Park, United States (Not yet recruiting)
    • Ashish Gupta (Principal Investigator)
  • ASHA Clinical Research - Munster, LLC, Hammond, United States (Recruiting)
    • Mohan Kesani (Principal Investigator)
  • Indiana University Health Methodist Hospital, Indianapolis, United States (Recruiting)
    • Rolf Kreutz (Principal Investigator)
  • Cardiovascular Research of Northwest Indiana, Munster, United States (Not yet recruiting)
    • Wail Asfour (Principal Investigator)
  • Deaconess Clinic- Gateway, Newburgh, United States (Recruiting)
    • Sridhar Banuru (Principal Investigator)
  • Flourish Research - Bowie, Bowie, United States (Recruiting)
    • Sara Collins (Principal Investigator)
  • Capitol Cardiology Associates - Lanham Office, Lanham, United States (Not yet recruiting)
    • Vineet Venugopal (Principal Investigator)
  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division, Troy, United States (Recruiting)
    • Neil Fraser (Principal Investigator)
  • Capital Area Research, LLC, Camp Hill, United States (Recruiting)
    • Venkatesh Nadar (Principal Investigator)
  • The Jackson Clinic, Jackson, United States (Recruiting)
    • Antwan Robinson (Principal Investigator)
  • East Coast Institute for Research - Jefferson City, Jefferson City, United States (Recruiting)
    • Pragnesh Patel (Principal Investigator)
  • Biopharma Informatic, LLC, Houston, United States (Recruiting)
    • Imran Ahmed Dar, MD (Principal Investigator)
  • Research Physicians Network, LLC, Houston, United States (Recruiting)
    • Nadish Garg, MD (Principal Investigator)
  • Sherman Clinical Research, Sherman, United States (Recruiting)
    • Tariq Yousuf (Principal Investigator)
  • NextStage Clinical Research - Waco, Waco, United States (Recruiting)
    • Donald Cross (Principal Investigator)
  • Alpine Research Organization, Clinton, United States (Recruiting)
    • Justin Mansfield (Principal Investigator)
  • Stroobants Cardiovascular Center, Lynchburg, United States (Recruiting)
    • Supawat Ratanapo (Principal Investigator)
  • Carient Heart & Vascular - Manassas, Manassas, United States (Not yet recruiting)
    • Hamid Taheri (Principal Investigator)
  • Clinical Research Partners, LLC, Richmond, United States (Recruiting)
    • Robert Call (Principal Investigator)
  • Gershon Pain Specialists, Virginia Beach, United States (Recruiting)
    • Steven Gershon (Principal Investigator)
  • ERA Health Research - CardioNow - Lynnwood, Lynnwood, United States (Not yet recruiting)
    • Mahesh Mulumudi (Principal Investigator)
  • Eastside Research Associates, Redmond, United States (Recruiting)
    • Christopher Price (Principal Investigator)
  • CIPREC, Buenos Aires, Argentina (Recruiting)
    • Fernando Guerlloy (Principal Investigator)
  • CIPREC, Buenos Aires, Argentina (Recruiting)
    • Angela Romero Zarante (Principal Investigator)
  • Sanatorio Finochietto, Buenos Aires, Argentina (Recruiting)
    • Nicolás Gonzalez (Principal Investigator)
  • CEMEDIC, Buenos Aires, Argentina (Recruiting)
    • Claudio Majul (Principal Investigator)
  • Instituto de Investigaciones Clínicas Córdoba, Córdoba, Argentina (Recruiting)
    • Ines Bartolacci (Principal Investigator)
  • MICA - Medicina e Investigación Cardiometabólica, Del Viso, Argentina (Not yet recruiting)
    • Micaela Mirada (Principal Investigator)
  • Centro de Investigaciones Clínicas Baigorria, Granadero Baigorria, Argentina (Recruiting)
    • Juan Dominguez (Principal Investigator)
  • DIM Clínica Privada, Ramos Mejía, Argentina (Recruiting)
    • Oscar Montaña (Principal Investigator)
  • Fundacion Estudios Clinicos, Rosario, Argentina (Recruiting)
    • María Schiavoni (Principal Investigator)
  • INECO Neurociencias Oroño, Rosario, Argentina (Recruiting)
    • Dana Miralles (Principal Investigator)
  • Instituto de Investigaciones Clinicas Rosario, Rosario, Argentina (Recruiting)
    • Carolina Chacón (Principal Investigator)
  • Go Centro Medico San Nicolás, San Nicolás, Argentina (Recruiting)
    • Paulina Lanchiotti (Principal Investigator)
  • Centro de Salud e Investigaciones Médicas, Santa Rosa, Argentina (Recruiting)
    • Marcos Mayer (Principal Investigator)
  • Box Hill Hospital, Box Hill, Australia (Recruiting)
    • Ming Li Yee (Principal Investigator)

And 120 other sites.

Study Officials

  • 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) (Study Director) — Eli Lilly and Company