Phase 3 Peripheral Arterial Disease Trial, Recruiting NCT07223593 Sponsor: Eli Lilly and Company Condition: Peripheral Arterial Disease
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Phase 3 Peripheral Arterial Disease Trial, Recruiting

NCT07223593
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have peripheral artery disease (PAD) that causes leg pain or cramping when walking (known as intermittent claudication), at a specific stage of severity called Fontaine Stage II.
  • People whose ankle-brachial index (ABI) score — a simple test that compares blood pressure in the ankle to blood pressure in the arm — is 0.9 or below, which indicates reduced blood flow to the legs.

Who may not be able to join:

  • People whose body mass index (BMI) is below 23 kg/m² (a measure of body weight relative to height that falls in the lower-normal or underweight range).
  • People whose HbA1c blood test result — a measure of average blood sugar levels over recent months — is above 10%, indicating poorly controlled blood sugar.
  • People whose ability to walk is limited by a condition other than PAD.
  • People who have a lower limb surgery planned, or any other surgery that would affect their ability to walk.
  • People who have had a procedure to restore blood flow to the legs within the 90 days before screening, or who are planning to have such a procedure during the trial.
  • People who have had a stroke, mini-stroke (TIA), heart attack, heart or neck artery procedure, or a hospital stay for severe chest pain within the 60 days before screening.
  • People who have been diagnosed with heart failure classified as stage III or IV under a standard medical scale, meaning significant or severe limitations on physical activity.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: 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), Eli Lilly and Company

Phone: 317-615-4559

Australian sites

Box Hill Hospital, Box Hill,
Core Research Group, Brisbane,
61738765688
Heart of Australia, Brisbane,
61 409497358
Canberra Hospital, Canberra,
University of the Sunshine Coast (UniSC) Clinical Trials - Meadowbrook, Meadowbrook,
Royal Perth Hospital, Perth,
Gold Coast University Hospital, Southport,
0438083132

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
31 October 2025
Est. completion
1 June 2028

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇫🇷 France 🇮🇳 India 🇯🇵 Japan 🇳🇱 Netherlands 🇵🇱 Poland Puerto Rico 🇸🇰 Slovakia 🇰🇷 South Korea 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

7 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percent Change from Baseline in Maximum Walking Distance

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov