A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee
- Conditions
- Osteoarthritis
- Interventions
- Drug: Placebo
- Registration Number
- NCT07153471
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 800
-
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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Orforglipron (GZT1) Orforglipron Participants will receive orforglipron orally Placebo (GZT1) Placebo Participants will receive placebo orally Orforglipron (GZT2) Orforglipron Participants will receive orforglipron orally Placebo (GZT2) Placebo Participants will receive placebo orally
- Primary Outcome Measures
Name Time Method Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Baseline, Week 72
- Secondary Outcome Measures
Name Time Method Change from Baseline in the WOMAC Physical Function Subscale Score Baseline, Week 72 Percent Change from Baseline in Body Weight Baseline, Week 72 Change from Baseline in 36-item, Short-Form Health Survey, version 2 (SF-36v2) Acute Form Physical Functioning Domain Score Baseline, Week 72 Change from Baseline in Distance Walked During the 6-Minute Walk Test Baseline, Week 72 Percent Change from Baseline in High-Sensitivity, C-reactive Protein (hsCRP) Baseline, Week 72 Change from Baseline in Waist Circumference Baseline, Week 72 Percent Change from Baseline in Tumor Necrosis Factor (TNF)-Alpha Baseline, Week 72 Change from Baseline in WOMAC Stiffness Subscale Baseline, Week 72 Change from Baseline in WOMAC Total Score Baseline, Week 72 Change from Baseline in SF-36v2 Acute Form Domain Scores Baseline, Week 72 With exception of the Physical Functioning Domain Score
Percentage of Participants Who Achieve Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Function Baseline, Week 72 Percentage of Participants Who Achieve Improved Categorical Shift in PGIS - Target Knee Pain Baseline, Week 72 Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score Baseline, Week 72 Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score Baseline, Week 72 Number of Participants with Allowed Concomitant Pain Medication Baseline, Week 72 Percent Change from Baseline in Total Cholesterol Baseline, Week 72 Pharmacokinetics (PK): Steady-State Area Under the Curve (AUC) of Orforglipron Predose through Week 48
Trial Locations
- Locations (84)
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
AMR Clinical
🇺🇸Knoxville, Tennessee, United States
Care Access - Huntington Beach
🇺🇸Huntington Beach, California, United States
Care Access - Thousand Oaks
🇺🇸Thousand Oaks, California, United States
Legacy Clinical Trials
🇺🇸Colorado Springs, Colorado, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Care Access - Decatur
🇺🇸Decatur, Georgia, United States
North Georgia Clinical Research
🇺🇸Woodstock, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
MedVadis Research Corporation
🇺🇸Waltham, Massachusetts, United States
Scroll for more (74 remaining)Arizona Research Center🇺🇸Phoenix, Arizona, United StatesLouise Taber MDPrincipal Investigator