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A study to evaluate the efficacy and safety of orforglipron in patients with peripheral artery disease

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is being conducted to investigate the efficacy and safety of orforglipron in individuals living with Peripheral Artery Disease. This condition involves narrowed or blocked blood vessels, which can reduce blood flow to the limbs. The study compares the effects of the experimental tablet against a placebo.

Participants will be assigned to different groups to receive either orforglipron or a placebo once daily by oral use. During the study, the ability to walk a certain distance will be monitored to see how the medication affects movement and physical activity over time.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the trial

    After joining the study, a 52-week period of treatment begins.

    A daily dose of either orforglipron, which is an oral tablet, or a placebo, which is a pill with no active medicine, is taken.

  2. Step 2

    Walking distance measurement

    At the beginning of the trial, a baseline measurement is taken to determine the maximum walking distance using a treadmill with a constant speed and incline.

    After 52 weeks of taking the daily medication, the maximum walking distance is measured again on the treadmill to evaluate any changes.

Who can join the trial?

4 criteria

  • You must have symptoms of Peripheral Arterial Disease, which is a condition where narrowed blood vessels reduce blood flow to your limbs, typically causing pain during physical activity.
  • You must experience pain when walking due to this condition.
  • You must be either male or female.
  • You must fall within the specific age range required for this study.

Who cannot join the trial?

4 criteria

  • Having a Body Mass Index (BMI), which is a measure of body fat based on your height and weight, of less than 23 kg/m2.
  • Having an HbA1c level, which is a blood test that shows your average blood sugar levels over the past few months, that is higher than 10%.
  • Having had or planning to have leg surgery designed to improve blood flow in your legs.
  • Having experienced a heart condition, which is any problem with the heart, within the 60 days before being checked for this study.
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Investigated drugs

Orforglipron is an oral tablet taken once a day that is being tested to see if it can help improve the walking distance for people with peripheral artery disease.

What is already known about the treatment

  • Orforglipron

    This medication is an experimental oral tablet taken once daily that is currently being studied in clinical trials. It belongs to a class of drugs known as GLP-1 receptor agonists, which are used to manage conditions like obesity and type 2 diabetes. At a molecular level, it works by mimicking a natural hormone in the body that helps regulate blood sugar and signals the brain to feel full. This trial specifically investigates its ability to improve physical function in people with peripheral arterial disease.

  • Placebo

    A placebo is an inactive substance, such as a pill, that looks exactly like the medication being tested but contains no active medicinal ingredients. It is used in clinical trials as a control to help researchers determine if the effects seen in patients are truly caused by the experimental drug. This substance is administered in the same way as the test medication to ensure the study remains unbiased. It has no therapeutic effect on medical conditions.

Investigated diseases

Peripheral Arterial Disease - This condition occurs when arteries that supply blood to the legs and feet become narrow or blocked. The buildup of fatty deposits inside these vessels restricts healthy blood flow. As the disease progresses, the reduced circulation can cause discomfort during physical activity. Over time, the narrowing may become more severe, affecting movement and daily activities.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523283-21-00Protocol codeJ2A-MC-GZPREstimated enrolment1 250 patientsSponsorEli Lilly & Co.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).