> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-of-orforglipron-in-participants-with-d3cb72a5-3bc0-460b-9c0f-8f39197d91bb > Record changed: 2026-10-13 # Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease NCT07223593 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) Participants 1,205 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) Start date 2025-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) Number of sites 159 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) **Acronym** ATTAIN-PAD Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) **Short title** Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) **Official 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) ## Dates **Completion date** 2028-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) **First posted** 2025-11-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) **Registry last updated** 2026-08-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) **Primary completion date** 2028-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) **Start date** 2025-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) ## Size and sites **Participants** 1,205 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) **Planned participants** 1,205 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) **Number of sites** 159 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) ## Identifiers **Registry ID** NCT07223593 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) **ClinicalTrials.gov ID** NCT07223593 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) ## Outcomes ### Primary outcomes 1. Percent Change from Baseline in Maximum Walking Distance Timeframe: Baseline, Week 52 On a constant load treadmill test ### Secondary outcomes 1. Percent Change from Baseline in Pain Free Walking Distance Timeframe: Baseline, Week 52 On a constant load treadmill test 2. Change from Baseline in Vascular Quality of Life (VascuQoL-6) Questionnaire Score Timeframe: Baseline, Week 52 3. Change from Baseline in 6 Minute Walk Test Distance (meters) Timeframe: Baseline, Week 52 4. Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) Timeframe: Baseline, Week 52 5. Change from Baseline in Systolic Blood Pressure (mmHg) Timeframe: Baseline, Week 52 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) ## Sites - St. Vincent's Birmingham HospitalBirmingham, United StatesRecruiting - Mercy Gilbert Medical CenterGilbert, United StatesRecruiting - Emvera Health at Peak Heart & Vascular SurpriseSurprise, United StatesNot yet recruiting - Del Sol Research Management, LLCTucson, United StatesRecruiting - Angel City Research Inc.Los Angeles, United StatesNot yet recruiting - Valley Clinical Trials, LLC dba Flourish ResearchNorthridge, United StatesRecruiting - The Cardiovascular CenterRedding, United StatesRecruiting - InvivoCureVan Nuys, United StatesRecruiting - Interventional Cardiology Medical GroupWest Hills, United StatesRecruiting - Rocky Mountain Regional VA Medical CenterAurora, United StatesNot yet recruiting - Lakeview Institute of Clinical ResearchLeesburg, United StatesRecruiting - Inpatient Research ClinicMiami Lakes, United StatesRecruiting - Floridian Clinical Research, LLCMiami Lakes, United StatesRecruiting - St Johns Center for Clinical ResearchSaint Augustine, United StatesRecruiting - ASHA Clinical Research - Munster, LLCHammond, United StatesRecruiting - Indiana University Health Methodist HospitalIndianapolis, United StatesRecruiting - Cardiovascular Research of Northwest IndianaMunster, United StatesNot yet recruiting - Deaconess Clinic- GatewayNewburgh, United StatesRecruiting - Flourish Research - BowieBowie, United StatesRecruiting - Capitol Cardiology Associates - Lanham OfficeLanham, United StatesNot yet recruiting - Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionTroy, United StatesRecruiting - Capital Area Research, LLCCamp Hill, United StatesRecruiting - The Jackson ClinicJackson, United StatesRecruiting - East Coast Institute for Research - Jefferson CityJefferson City, United StatesRecruiting - Biopharma Informatic, LLCHouston, United StatesRecruiting And 134 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/663317) ### Other registry identifiers (3) - 2025 - 2025-523283-21-00 - J2A-MC-GZPR Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07223593) ## Related records ### Drugs (1) - [Orforglipron](https://trialight.com/data/asset/orforglipron-1138c12b-f1c7-45bb-b9ec-2b693f019a62.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (1) - [Peripheral arterial disease](https://trialight.com/data/condition/peripheral-arterial-disease-660376f2-3d22-5c83-86ea-1d146307e09b.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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