Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

Short name ATTAIN-PAD

NCTNCT07223593Other id27632Other id2025-523283-21-00Other idJ2A-MC-GZPROther id2025

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 3
Enrollment: 1,205 participants (estimated)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Double masking
Countries: 18 countries
United States, Argentina, Australia, Brazil, Canada, China, France, Greece, India, Israel, Japan, Netherlands, Poland, Puerto Rico, Slovakia, South Korea, Taiwan, United Kingdom
Start: 31 Oct 2025
Primary completion: Jun 2028 (estimated)
Completion: Jun 2028 (estimated)
First posted: 3 Nov 2025
Last update posted: 8 Oct 2026
Conditions: Peripheral Arterial Disease

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20252026202720282029

Ph 3
ATTAIN-PAD
NCT07223593
31 Oct 2025 to est. Jun 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

OrforglipronDrug
PlaceboDrug

Arms2

Experimental
Orforglipron
Participants will receive orforglipron orally
Placebo comparator
Placebo
Participants will receive placebo orally

Primary outcomes1

Outcomes the sponsor listed as primary.

Percent Change from Baseline in Maximum Walking Distance
Time frame · Baseline, Week 52
Registry description
On a constant load treadmill test

Secondary outcomes(5)

Percent Change from Baseline in Pain Free Walking Distance
Time frame · Baseline, Week 52
Registry description
On a constant load treadmill test
Change from Baseline in Vascular Quality of Life (VascuQoL-6) Questionnaire Score
Time frame · Baseline, Week 52
Change from Baseline in 6 Minute Walk Test Distance (meters)
Time frame · Baseline, Week 52
Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Time frame · Baseline, Week 52
Change from Baseline in Systolic Blood Pressure (mmHg)
Time frame · Baseline, Week 52

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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