Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

What Was Tested

The trial (phase 3) is built around Orforglipron (Foundayo, non-peptide).

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.

It had two arms (groups): Orforglipron (experimental) and Placebo (placebo comparator).

Participants will receive orforglipron orally.

Participants will receive placebo orally.

The registry classes the interventions as drug.

Who Took Part

The registry lists 1205 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have symptomatic PAD with intermittent claudication of Fontaine Stage II. Have an Ankle Brachial Index (ABI) of 0.9 or less.

The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: have a body mass index (bmi) less than 23 kilogram per square meter (kg/m2); have walking ability limited by conditions other than pad; have a planned lower limb surgery or any other surgery affecting walking ability.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Orforglipron (Foundayo, non-peptide) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Orforglipron (Foundayo, non-peptide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2025-10-31 with completion listed for 2028-06.

It ran at 170 sites in United States (36), Japan (25), China (18), Argentina (13), India (11) and Australia (9).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent Change from Baseline in Maximum Walking Distance (time frame: Baseline, Week 52).

It also tracked 5 secondary outcomes, for example Percent Change from Baseline in Pain Free Walking Distance, Change from Baseline in Vascular Quality of Life (VascuQoL-6) Questionnaire Score, Change from Baseline in 6 Minute Walk Test Distance (meters), Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) and Change from Baseline in Systolic Blood Pressure (mmHg).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Orforglipron (Foundayo, non-peptide) in 1205 people.

With 1205 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Orforglipron (Foundayo, non-peptide) compound page, all human trials.