ATTAIN-PADOrforglipron for Peripheral Artery Disease
The study aims to evaluate if Orforglipron can improve maximum walking distance in people with peripheral artery disease.
Orforglipron
+ Placebo
Arterial Occlusive Diseases+4
+ Arteriosclerosis
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: October 31, 2025
Actual date on which the first participant was enrolled.This clinical trial is designed to assess the effectiveness and safety of a medication called orforglipron, which is taken once daily, for individuals suffering from peripheral artery disease (PAD), specifically those classified as Fontaine II. Fontaine II PAD refers to a stage where patients experience leg pain during exercise. The study aims to determine if orforglipron can improve the condition by potentially increasing the distance patients can walk without pain. This investigation is significant as PAD is a common circulatory problem, and finding a reliable treatment could greatly enhance the quality of life for those affected. Participants in this study will take the medication or a placebo daily for about 58 weeks. The trial is set up in a way where neither the participants nor the researchers know who is receiving the actual medication or the placebo, ensuring unbiased results. The effectiveness of the treatment will be measured by looking at the change in the maximum distance participants can walk on a treadmill over time. This study structure aims to provide clear insights into how well the medication works and its safety profile for people with this condition.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1205 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 139 locations
Axsendo Clinical Research - Peak Heart & Vascular - Surprise
Surprise, United StatesOpen Axsendo Clinical Research - Peak Heart & Vascular - Surprise in Google MapsDel Sol Research Management, LLC
Tucson, United StatesValley Clinical Trials, Inc.
Northridge, United StatesThe Cardiovascular Center
Redding, United States