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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Orforglipron 		Participants will receive orforglipron orally
  • Drug: Orforglipron
    Administered orally
    Other names:
    • LY3502970
Placebo Comparator
Placebo 		Participants will receive placebo orally
  • Drug: Placebo
    Administered orally

Recruiting Locations

St. Vincent's Birmingham Hospital
Birmingham, Alabama 35205

Mercy Gilbert Medical Center
Gilbert, Arizona 85297
Contact:
602-214-0886

Emvera Health at Peak Heart & Vascular Surprise
Surprise, Arizona 85378
Contact:
844-290-2273

Del Sol Research Management, LLC
Tucson, Arizona 85715
Contact:
520-257-3881

Valley Clinical Trials, LLC dba Flourish Research
Northridge, California 91325
Contact:
818-280-4220

The Cardiovascular Center
Redding, California 96001
Contact:
281-944-3610

InvivoCure
Van Nuys, California 91405
Contact:
859-509-0084

Interventional Cardiology Medical Group
West Hills, California 91307
Contact:
818-702-8800

Lakeview Institute of Clinical Research
Leesburg, Florida 34748
Contact:
352-782-0606

Inpatient Research Clinic
Miami Lakes, Florida 33014
Contact:
786-502-4303

Floridian Clinical Research, LLC
Miami Lakes, Florida 33016-1518
Contact:
305-330-9977

St Johns Center for Clinical Research
Saint Augustine, Florida 32086
Contact:
904-209-0043

ASHA Clinical Research - Munster, LLC
Hammond, Indiana 46324
Contact:
219-803-6649

Indiana University Health Methodist Hospital
Indianapolis, Indiana 46202

Deaconess Clinic- Gateway
Newburgh, Indiana 47630
Contact:
812-490-4505

Flourish Research - Bowie
Bowie, Maryland 20715
Contact:
410-824-1341

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan 48098
Contact:
248-312-0025

Capital Area Research, LLC
Camp Hill, Pennsylvania 17011
Contact:
717-441-1725

The Jackson Clinic
Jackson, Tennessee 38305
Contact:
731-660-8396

East Coast Institute for Research - Jefferson City
Jefferson City, Tennessee 37760

Biopharma Informatic, LLC
Houston, Texas 77084
Contact:
281-944-3610

Research Physicians Network, LLC
Houston, Texas 77089
Contact:
832-847-1724

Sherman Clinical Research
Sherman, Texas 75090
Contact:
903-771-4093

NextStage Clinical Research - Waco
Waco, Texas 76712

Alpine Research Organization
Clinton, Utah 84015
Contact:
801-791-2206

Stroobants Cardiovascular Center
Lynchburg, Virginia 24501

Clinical Research Partners, LLC
Richmond, Virginia 23226
Contact:
804-477-3045

Gershon Pain Specialists
Virginia Beach, Virginia 23454
Contact:
757-496-2050

ERA Health Research - CardioNow - Lynnwood
Lynnwood, Washington 98036
Contact:
425-869-6828

Eastside Research Associates
Redmond, Washington 98052
Contact:
425-869-6828

Research and Cardiovascular Corp.
Ponce, Puerto Rico 00717
Contact:
787-290-8585

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.