Osteoarthritis, Overweight or Obesity
Conditions
Brief summary
The YDAN master protocol will support two independent studies, J3R-MC-YOA1 and J3R-MC-YOA2. Each study will investigate how well and safely Eloralintide (LY3841136) works in adults with obesity or overweight who have osteoarthritis (OA) of the knee with pain. Participation in the study will last about 75 weeks, including screening.
Interventions
DRUGEloralintide
Administered SC
DRUGPlacebo
Placebo administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a body mass index (BMI) of 27 kilograms per square meter (kg/m²) or higher at screening * Have a stable body weight (less than 5% body weight change) for 90 days prior to 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 a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed greater than 1 year before screening) * Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening) * Have type 1 diabetes, type 2 diabetes, or any other type of diabetes * Have an active knee infection * Have had within 90 days prior to screening: * heart attack * stroke * coronary artery revascularization * unstable angina, or * hospitalization due to congestive heart failure * Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure * Have taken medications or alternative remedies intended for weight loss within 90 days of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 64 | Percent Change from Baseline in Body Weight |
| Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Baseline, Week 64 | Change from Baseline in the WOMAC Pain Subscale Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 64 | Change from Baseline in SBP |
| Percent Change from Baseline in Triglycerides | Baseline, Week 64 | Percent Change in Baseline in Triglycerides |
| Change from Baseline in Short Form-36 (SF-36 v2) Acute Form Physical Functioning Domain Score | Baseline, Week 64 | Change from Baseline in SF-36 v2 Score |
| Percent Change from Baseline in High Sensitivity, C-reactive Protein (hsCRP) | Baseline, Week 64 | Percent Change from Baseline in hsCRP |
| Change from Baseline in the WOMAC Physical Function Subscale Score | Baseline, Week 40, Week 64 | Change from Baseline in the WOMAC Physical Function Subscale Score |
| Change from Baseline WOMAC Pain Subscale Score | Baseline, Week 40 | Change from Baseline WOMAC Pain Subscale Score |
| Change from Baseline in Distance Walked During the 6-Minute Walk Test | Baseline, Week 64 | Change from Baseline in Distance Walked During the 6-Minute Walk Test |
| Change from Baseline in Body Mass Index (BMI) | Baseline, Week 64 | Change from Baseline in BMI |
| Change in Medication Use | Baseline, Week 64 | Change in Medication Use |
| Change from Baseline in SF-36v2 Acute Form Domain Scores With Exception of the Physical Functioning Domain Score | Baseline, Week 64 | Change from Baseline in SF-36v2 Acute Form Domain Scores With Exception of the Physical Functioning Domain Score |
| Change from Baseline in Health Status EQ-5D-5L Health State Utility | Baseline, Week 64 | Change from Baseline in Health Status EQ-5D-5L Health State Utility |
| Percent Change from Baseline in Fasting Insulin | Baseline, Week 64 | Percent Change from Baseline in Fasting Insulin |
| Percent Change from Baseline in Total Cholesterol | Baseline, Week 64 | Percent Change from Baseline in Total Cholesterol |
| Change from Baseline in Waist Circumference | Baseline, Week 64 | Change from Baseline in Waist Circumference |
| Percent Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 64 | Percent Change from Baseline in HbA1c |
| Change from Baseline in WOMAC Stiffness Subscale Score | Baseline, Week 64 | Change from Baseline in WOMAC Stiffness Subscale Score |
| Change from Baseline in WOMAC Total Score | Baseline, Week 64 | Change from Baseline in WOMAC Total Score |
| Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Pain | Baseline, Week 64 | Achievement of Improved Categorical Shift in PGIS - Target Knee Pain |
| Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Function | Baseline, Week 64 | Achievement of Improved Categorical Shift in PGIS - Target Knee Function |
| Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score | Baseline, Week 64 | Change from Baseline in API-NRS Score |
| Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score | Baseline, Week 64 | Change from Baseline in WPI-NRS Score |
| Pharmacokinetics (PK): Maximum Concentration at Steady State (Cmax, ss) | Baseline through Week 64 | PK: Cmax, ss |
| PK: Area Under the Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-T)ss) | Baseline through Week 64 | PK: AUC(0-T)ss |
| Number of Participants with Allowed Concomitant Pain Medication | Baseline, Week 64 | Number of Participants with Allowed Concomitant Pain Medication |
Countries
Argentina, Belgium, Brazil, Canada, China, Czechia, Denmark, Germany, Japan, Mexico, Puerto Rico, South Korea, Taiwan, United Kingdom, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed