J2A-MC-GZPR
Research type
Research Study
Full 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.
IRAS ID
1012984
Contact name
Maryna Kvochka
Contact email
Sponsor organisation
Eli Lilly and Company
Research summary
GLP-1 receptor agonists are established treatments for blood sugar control in type 2 diabetes, as well as weight management in people who are overweight or have obesity. GLP-1 receptor agonists approved by regulatory authorities to date are injectable and oral peptides (small proteins). Study drug orforglipron (LY3502970) is an oral, nonpeptide, small-molecule GLP-1 RA.
Orforglipron is currently in development as a treatment for multiple disease areas. These include treating type 2 diabetes and chronic weight management in people who are overweight or have obesity. Additionally, researchers believe that orforglipron will improve physical function and mobility in peripheral artery disease (PAD) by improving how blood vessels work, reducing chronic low-grade inflammation, lowering blood pressure, improving blood sugar, and reducing weight in study participants.
The purpose of this study is to investigate the efficacy and safety of orforglipron once daily in participants with PAD and is a randomised, double-blind, placebo-controlled, 52-week, phase 3 clinical trial. Approximately 1200 participants will be randomly assigned to either orforglipron or placebo in a 1:1 ratio (600 participants per treatment group). 60 participants in total will be recruited in the United Kingdom.REC name
London - Westminster Research Ethics Committee
REC reference
25/LO/0860
Date of REC Opinion
17 Dec 2025
REC opinion
Further Information Favourable Opinion