Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

NCT07223593
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Recruitment status
Recruiting
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Participants
1,205
clinicaltrials.gov
Lead sponsor
Eli Lilly and Company
clinicaltrials.gov
Start date
2025-10-31
clinicaltrials.gov
Number of sites
159
clinicaltrials.gov

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.
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Acronym
ATTAIN-PAD
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Short title
Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease
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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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2028-06-01
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First posted
2025-11-03
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Registry last updated
2026-08-21
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Primary completion date
2028-06-01
clinicaltrials.gov
Start date
2025-10-31
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Participants
1,205
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Participant count basis
Estimated
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Planned participants
1,205
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Protocol amendments
0
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Number of sites
159
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07223593
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07223593
clinicaltrials.gov
Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Percent Change from Baseline in Maximum Walking Distance

    Timeframe: Baseline, Week 52

    On a constant load treadmill test

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

  • 2025
  • 2025-523283-21-00
  • J2A-MC-GZPR
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)