A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee

Purpose

The GZPT master protocol will support two independent studies, J2A-MC-GZT1 and J2A-MC-GZT2. Each study will see how well and safely orforglipron works in people with obesity or overweight who have osteoarthritis (OA) of the knee with pain. Participation in the study will last about 74 weeks.

Condition

  • Osteoarthritis

Eligibility

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

Inclusion Criteria

  • Have a body mass index (BMI) of 27 kilograms per square meter (kg/m2) or higher at screening - Have tried at least once to lose weight through diet but were unsuccessful - Have osteoarthritis of the knee and at least one of the following conditions: - Be over 50 years old - Have morning knee stiffness that lasts about 30 minutes - Have a crackling or grinding sound or feeling in the knee

Exclusion Criteria

  • Have gained or lost more than 11 pounds within 90 days prior to screening - Have had a surgery for obesity or plan to have one in the next 18 months - Have an active knee infection - Have type 1 diabetes, type 2 diabetes, or any other type of diabetes - Have had a recent heart condition or New York Heart Association Functional Classification Class IV congestive heart failure - Have used any glucagon-like peptide-1 (GLP-1) receptor agonist medication within 180 days of screening

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Orforglipron (GZT1) 		Participants will receive orforglipron orally
  • Drug: Orforglipron
    Administered orally
    Other names:
    • (LY3502970)
Placebo Comparator
Placebo (GZT1) 		Participants will receive placebo orally
  • Drug: Placebo
    Administered orally
Experimental
Orforglipron (GZT2) 		Participants will receive orforglipron orally
  • Drug: Orforglipron
    Administered orally
    Other names:
    • (LY3502970)
Placebo Comparator
Placebo (GZT2) 		Participants will receive placebo orally
  • Drug: Placebo
    Administered orally

Recruiting Locations

Arizona Research Center
Phoenix, Arizona 85053
Contact:
602-863-6363

AMR Clinical
Tempe, Arizona 85281
Contact:
602-910-3343

Care Access - Huntington Beach
Huntington Beach, California 92648
Contact:
714-378-2440

Care Access - Thousand Oaks
Thousand Oaks, California 91360
Contact:
805-778-5143

Legacy Clinical Trials
Colorado Springs, Colorado 80909
Contact:
719-387-7572

Chase Medical Research, LLC
Waterbury, Connecticut 06708
Contact:
203-419-4420

Care Access - Decatur
Decatur, Georgia 30030
Contact:
678-470-4394

North Georgia Clinical Research
Woodstock, Georgia 30189
Contact:
678-494-5735

Northwestern University
Chicago, Illinois 60611
Contact:
312-503-2315

AMR Clinical
Newton, Kansas 67114
Contact:
316-804-7304

MedVadis Research Corporation
Waltham, Massachusetts 02451
Contact:
617-744-1310

StudyMetrix Research
City of Saint Peters, Missouri 63303
Contact:
636-387-5100

AMR Clinical
Kansas City, Missouri 64114

Cardio Metabolic Institute
Somerset, New Jersey 08873
Contact:
732-846-7000 x 108

Carolina Research Center
Shelby, North Carolina 28150
Contact:
704-600-6052

University Orthopedics Center
Altoona, Pennsylvania 16602

Care Access - Rapid City
Rapid City, South Dakota 57701
Contact:
877-791-0656

AMR Clinical
Knoxville, Tennessee 37909
Contact:
865-305-9100

Mercy Family Clinic
Dallas, Texas 75208
Contact:
281-944-3610

Juno Research
Houston, Texas 77040
Contact:
713-779-5494

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

Activian Clinical Research
Kingwood, Texas 77339
Contact:
832-969-3401

Advanced Rheumatology of Houston - Woodlands
The Woodlands, Texas 77382
Contact:
936-681-4882

Charlottesville Medical Research
Charlottesville, Virginia 22911
Contact:
434-817-2442

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

Northwest Clinical Research Center
Bellevue, Washington 98007

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

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