Efficacy and Safety of Orforglipron in Participants with Peripheral Artery Disease: A Randomized, Double-Blind, Placebo-Controlled Trial

The primary objective of this study is to evaluate the efficacy of orforglipron in increasing the maximum walking distance in patients diagnosed with peripheral artery disease. This investigation aims to demonstrate the superiority of the investigational product compared to a placebo. The study also includes assessments related to safety and pharmacokinetics.

The study involves a total of 1065 patients. The participant population includes both males and females within specific age ranges. Inclusion is based on the presence of symptoms related to peripheral arterial disease, specifically characterized by claudication during ambulation. The primary objective is to evaluate the efficacy of orforglipron in increasing maximum walking distance compared to a placebo.

This randomized, double-blind, placebo-controlled trial is designed to investigate the efficacy and safety of orforglipron in participants with peripheral artery disease. The primary objective is to demonstrate the superiority of the investigational product compared to a placebo in increasing the maximum walking distance measured via a constant load treadmill test. The study involves a screening process to identify individuals presenting with symptoms of the disease, such as pain during ambulation. Following baseline assessments, participants will receive a once-daily oral dose of either the test medication or a matching placebo. The clinical evaluation includes a 52-week period to monitor the percent change from baseline in the primary endpoint. The overall trial is estimated to occur between January 2026 and February 2028.

The experimental medication is orforglipron, which contains the active substance orforglipron hemicalcium. This investigational product is administered as an oral tablet once daily.

A matching placebo is utilized as a comparator treatment in this study.

The efficacy of the investigational product is evaluated by assessing the percent change from baseline in maximum walking distance. This primary endpoint is measured using a constant load treadmill test at baseline and at week 52. The study aims to demonstrate the superiority of orforglipron compared to placebo in participants with peripheral artery disease.