Orforglipron for Peripheral Artery Disease

(ATTAIN-PAD Trial)

Recruiting at 132 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Disqualifiers: Low BMI, High HbA1c, Heart failure, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

1205 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effects of orforglipron, a new daily pill for people with peripheral artery disease (PAD). PAD often causes leg pain during walking, known as intermittent claudication. Participants will take either orforglipron or a placebo (a pill with no active medicine) for about 58 weeks. The trial seeks individuals with PAD who experience leg pain when walking and have an Ankle Brachial Index (a simple test for blood flow) of 0.9 or less. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the development of a potentially new treatment for PAD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that orforglipron is likely to be safe for humans?

Research shows that orforglipron is generally safe for patients. This small drug helps lower A1C levels, a measure of blood sugar control. Earlier studies found no serious safety issues with orforglipron. Most side effects were mild to moderate, such as stomach upset or mild nausea, and they typically improved over time. As this treatment is in a later testing phase, more information about its safety is available. This phase usually indicates that earlier studies have already demonstrated its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for PAD?

Orforglipron is unique because it offers a new approach to treating peripheral artery disease. Unlike most standard treatments that focus on improving blood flow through lifestyle changes, medications like statins or antiplatelets, or procedures like angioplasty, Orforglipron is an oral medication that targets metabolic pathways. Researchers are excited about its potential to address underlying metabolic issues that contribute to the disease, possibly offering a more effective and convenient treatment option. This innovative mechanism could mean better outcomes for patients who haven't responded well to traditional therapies.

What evidence suggests that orforglipron might be an effective treatment for peripheral artery disease?

Research has shown that orforglipron, a pill, could be a promising treatment for peripheral artery disease (PAD). Participants in this trial will receive either orforglipron or a placebo. Orforglipron affects GLP-1, a hormone that helps control blood sugar levels. It has reduced A1C, a measure of blood sugar, by 1.3% to 1.6% in other conditions. This suggests it might also improve blood flow in the arteries, which is important for people with PAD. While specific results for PAD are still being collected, its success in managing blood sugar provides a strong basis for its potential benefits in treating PAD symptoms. ^{1 2 3 4 5}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for individuals with Fontaine II peripheral arterial disease (PAD). Specific eligibility criteria are not provided, but typically participants must meet certain health conditions and agree to follow the study protocol.

Inclusion Criteria

Have an Ankle Brachial Index (ABI) of 0.9 or less

I experience leg pain from walking due to PAD.

Exclusion Criteria

Have a body mass index (BMI) less than 23 kilogram per square meter (kg/m2)

Have Hemoglobin A1c (HbA1c) greater than 10%

My walking is limited by a condition that is not related to leg artery problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive orforglipron or placebo orally once daily

52 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Orforglipron

Trial Overview

The trial is testing the effectiveness and safety of a medication called Orforglipron, taken once daily by people with PAD. It's compared against a placebo over approximately 58 weeks to see if it improves their condition.

How Is the Trial Designed?

Group I: Orforglipron Experimental Treatment 1 Intervention

Participants will receive orforglipron orally

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo orally

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07223593

Efficacy and Safety of Orforglipron in Participants With ...

The purpose of this study is to evaluate the effect and safety of orforglipron once daily in participants with Fontaine II peripheral ...

2.

trial.medpath.com

trial.medpath.com/clinical-trial/944737808ac3c8bb/nct07223593-orforglipron-efficacy-safety-peripheral-artery-disease

Efficacy and Safety of Orforglipron in Participants ... - MedPath

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) ...

3.

withpower.com

withpower.com/trial/phase-3-peripheral-arterial-disease-11-2025-df387

Orforglipron for Peripheral Artery Disease (ATTAIN-PAD ...

The purpose of this study is to evaluate the effect and safety of orforglipron once daily in participants with Fontaine II peripheral ...

4.

ctv.veeva.com

ctv.veeva.com/study/efficacy-and-safety-of-orforglipron-in-participants-with-peripheral-artery-disease

Efficacy and Safety of Orforglipron in Participants With ...

The purpose of this study is to evaluate the effect and safety of orforglipron once daily in participants with Fontaine II peripheral ...

5.

investor.lilly.com

investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-demonstrated-statistically

Lilly's oral GLP-1, orforglipron, demonstrated statistically ...

Orforglipron is the first small molecule GLP-1 to successfully complete a Phase 3 trial, lowering A1C by an average of 1.3% to 1.6% across doses.