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

Investigating the Effects of an Investigational Medication on Peripheral Artery Disease (PAD)

R
Rolf Kreutz, MD

Primary Investigator

Enrolling By Invitation
18 years or above
All
Phase N/A
2 participants needed
2 Locations

Brief description of study

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.

THIS STUDY IS ENROLLING BY INVITATION ONLY 

Detailed description of study

Study GZPR is a randomized, double-blind, placebo-controlled, 52-week, Phase 3 study
evaluating treatment with orforglipron MTD (9 mg, 14.5 mg, or 17.2 mg) in participants with
PAD. Approximately 1200 participants will be randomized in a 1:1 ratio (600 participants per
intervention group) to receive orforglipron MTD or placebo for 52 weeks. Orforglipron dose will
be escalated every 4 weeks during the first 20 weeks to achieve MTD; after the first 20 weeks,
the dose will be maintained throughout the treatment period.
The expected total duration of study participation for each participant, including screening,
treatment period, and safety follow-up periods, is 58 weeks across the following treatment
periods:
 Screening: 4 weeks
 Treatment: 52 weeks
 Safety follow-up: 2 weeks
 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Peripheral Arterial Disease, PAD
  • Age: 18 years or above
  • Gender: All

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

This study investigates the effects and safety of an investigational medication taken once daily in people with peripheral artery disease (PAD). PAD is a condition where the blood vessels, usually in the legs, are narrowed, reducing blood flow and causing pain during walking, known as intermittent claudication. The purpose of this study is to understand how this medication works in people with PAD at Fontaine Stage II, which is characterized by pain when walking that is relieved by rest.

Participants in the study will be randomly assigned to receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study is double-blind, meaning neither the participants nor the researchers know who is receiving the medication or the placebo. The dosage of the investigational medication will be increased every 4 weeks for the first 20 weeks to find the most suitable dose, and then maintained for the rest of the study period.

  • Who can participate: Participants must have symptomatic PAD with intermittent claudication of Fontaine Stage II and an Ankle Brachial Index (ABI) of 0.9 or less. They should not have a BMI less than 23 kg/m2 or an HbA1c greater than 10%.
  • Study details: Participants will be randomly assigned to receive either the investigational medication or a placebo. The dosage will be increased every 4 weeks for the first 20 weeks to find the most suitable dose, and then maintained for the rest of the study period.
  • Study timelines: The study will last 58 weeks.
Updated on 25 Feb 2026. Study ID: ECRO-LILLY-ATTAIN-PAD, 29300
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only