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RECRUITING Phase 3

Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

NCT07223593 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Orforglipron

Study Locations (20)

California

  • Valley Clinical Trials, Inc. — Northridge
  • The Cardiovascular Center — Redding
  • InvivoCure — Van Nuys
  • Interventional Cardiology Medical Group — West Hills

Florida

  • Lakeview Institute of Clinical Research — Leesburg
  • Inpatient Research Clinic — Miami Lakes
  • Floridian Clinical Research, LLC — Miami Lakes
  • St Johns Center for Clinical Research — Saint Augustine

Arizona

  • Mercy Gilbert Medical Center — Gilbert
  • Axsendo Clinical Research - Peak Heart & Vascular - Surprise — Surprise
  • Del Sol Research Management, LLC — Tucson

Indiana

  • ASHA Clinical Research - Munster, LLC — Hammond
  • Indiana University Health Methodist Hospital — Indianapolis
  • Deaconess Clinic- Gateway — Newburgh

Tennessee

  • The Jackson Clinic — Jackson
  • East Coast Institute for Research - Jefferson City — Jefferson City

Alabama

  • St. Vincent's Birmingham Hospital — Birmingham

Maryland

  • Flourish Research - Bowie — Bowie

Michigan

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy

Trial Details

FieldValue
Enrollment Target 1,205 participants
Start Date 2025-10-31
Est. Completion 2028-06
Phase Phase 3

Sponsor

Eli Lilly and Company

704 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07223593

The ClinicalTrials.gov registry entry for NCT07223593 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,205 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 704 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07223593 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07223593 about?

NCT07223593 is a clinical study titled "Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease". 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.

What is the current status of trial NCT07223593?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,205 participants. The study started on 2025-10-31. Estimated completion is 2028-06.

What conditions does trial NCT07223593 study?

This clinical trial studies the following conditions: Peripheral Arterial Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07223593?

The interventions under investigation include: Placebo (DRUG), Orforglipron (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07223593?

This trial is sponsored by Eli Lilly and Company, which has 704 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07223593 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial