Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease (ATTAIN-PAD)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Peripheral Arterial Disease

Treatments: Drug: Orforglipron; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07223593

2025-523283-21-00 (EU Trial (CTIS) Number)

27632

J2A-MC-GZPR (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,205 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,205 participants in 2 patient groups, including a placebo group

Orforglipron

Experimental group

Description:

Participants will receive orforglipron orally

Treatment:

Drug: Orforglipron

Placebo

Placebo Comparator group

Description:

Participants will receive placebo orally

Treatment:

Drug: Placebo