Recruiting PHASE3 Peripheral Arterial Disease

Tests treatment safety and results for Peripheral Arterial Disease

Official title Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

ClinicalTrials.gov ID: NCT07223593

What this study is testing

What is Orforglipron?

Orforglipron is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for peripheral arterial disease.

Also referred to as LY3502970.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Have symptomatic PAD with intermittent claudication of Fontaine Stage II
  • Have an Ankle Brachial Index (ABI) of 0.9 or less

You likely can't join if

  • 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...
  • Had stroke, transient ischemic attack, myocardial infarction, coronary or carotid revascularization, or hospitalization for unstable angina pectoris...
See the full eligibility criteria
Who can join
  • Have symptomatic PAD with intermittent claudication of Fontaine Stage II
  • Have an Ankle Brachial Index (ABI) of 0.9 or less
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Birmingham, Alabama, United States
  • Gilbert, Arizona, United States
  • Surprise, Arizona, United States
  • Tucson, Arizona, United States
  • Los Angeles, California, United States
  • Northridge, California, United States
  • Redding, California, United States
  • Van Nuys, California, United States
  • West Hills, California, United States
  • Aurora, Colorado, United States
  • Leesburg, Florida, United States
  • Miami Lakes, Florida, United States
  • Saint Augustine, Florida, United States
  • Hammond, Indiana, United States
  • Indianapolis, Indiana, United States
  • Newburgh, Indiana, United States
  • Bowie, Maryland, United States
  • Troy, Michigan, United States
  • Camp Hill, Pennsylvania, United States
  • Jackson, Tennessee, United States

+ 107 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Birmingham, Alabama, United States; Gilbert, Arizona, United States; Surprise, Arizona, United States; Tucson, Arizona, United States; Los Angeles, California, United States; Northridge, California, United States and 121 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.