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NCT Number: NCT07223593

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CEMEDIC, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Orforglipron

Drug

Administered orally

Other names: LY3502970

Placebo

Drug

Administered orally

Primary outcomes

  1. Percent Change from Baseline in Maximum Walking Distance

    Time frame: Baseline, Week 52

    On a constant load treadmill test

Secondary outcomes

  1. Percent Change from Baseline in Pain Free Walking Distance

    Time frame: Baseline, Week 52

    On a constant load treadmill test

  2. Change from Baseline in Vascular Quality of Life (VascuQoL-6) Questionnaire Score

    Time frame: Baseline, Week 52

  3. Change from Baseline in 6 Minute Walk Test Distance (meters)

    Time frame: Baseline, Week 52

  4. Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)

    Time frame: Baseline, Week 52

  5. Change from Baseline in Systolic Blood Pressure (mmHg)

    Time frame: Baseline, Week 52

Interested in participating?

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Acronym: ATTAIN-PAD

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 3, 2025
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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