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

RK

Rolf Kreutz, MD

Principal Investigator

Status: Enrolling By Invitation Ages: 18 Years Gender: All Genders Phase: N/A 2 Locations

Brief Description

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.

THIS STUDY IS ENROLLING BY INVITATION ONLY 

Detailed Description

Study GZPR is a randomized, double-blind, placebo-controlled, 52-week, Phase 3 study
evaluating treatment with orforglipron MTD (9 mg, 14.5 mg, or 17.2 mg) in participants with
PAD. Approximately 1200 participants will be randomized in a 1:1 ratio (600 participants per
intervention group) to receive orforglipron MTD or placebo for 52 weeks. Orforglipron dose will
be escalated every 4 weeks during the first 20 weeks to achieve MTD; after the first 20 weeks,
the dose will be maintained throughout the treatment period.
The expected total duration of study participation for each participant, including screening,
treatment period, and safety follow-up periods, is 58 weeks across the following treatment
periods:
 Screening: 4 weeks
 Treatment: 52 weeks
 Safety follow-up: 2 weeks
 

Eligibility of study

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

Interested in participating?

Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Many studies only accept people who are part of an invited group. Visit allinforhealth.info to connect with the study team, or contact your doctor to see if you are eligible.