Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain and Obesity or Overweight

Phase 3Not Yet RecruitingNCT07353931

Eli Lilly and Company900 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

900

Conditions

Osteoarthritis Overweight or Obesity

Interventions

EloralintideDRUG

Administered SC

PlaceboDRUG

Placebo administered SC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (155)

Outcomes

Primary Outcomes

Percent Change from Baseline in Body Weight

Time frame: Baseline, Week 64

Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score

Change from Baseline in the WOMAC Pain Subscale Score

Time frame: Baseline, Week 64

Secondary Outcomes

Change from Baseline in Systolic Blood Pressure (SBP)

Change from Baseline in SBP

Time frame: Baseline, Week 64

Percent Change from Baseline in Triglycerides

Percent Change in Baseline in Triglycerides

Time frame: Baseline, Week 64

Change from Baseline in Short Form-36 (SF-36 v2) Acute Form Physical Functioning Domain Score

Change from Baseline in SF-36 v2 Score

Time frame: Baseline, Week 64

Percent Change from Baseline in High Sensitivity, C-reactive Protein (hsCRP)

Percent Change from Baseline in hsCRP

Time frame: Baseline, Week 64

Change from Baseline in the WOMAC Physical Function Subscale Score

Time frame: Baseline, Week 40, Week 64

Change from Baseline WOMAC Pain Subscale Score

Central Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

AMR Clinical

Mobile, Alabama, United States

Care Access - 801 South Power Road, Mesa

Mesa, Arizona, United States

Elite Pain and Spine Institute - South Crimson Road

Mesa, Arizona, United States

Tucson Orthopaedic Institute - North Wyatt Drive

Tucson, Arizona, United States

Ark Clinical Research - Fountain Valley

Fountain Valley, California, United States

Wolverine Clinical Trials

Santa Ana, California, United States

Encompass Clinical Research

Spring Valley, California, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Westside Center for Clinical Research

Jacksonville, Florida, United States

Care Access - St. Petersburg

St. Petersburg, Florida, United States

...and 145 more locations

Time frame: Baseline, Week 40

Change from Baseline in Distance Walked During the 6-Minute Walk Test

Time frame: Baseline, Week 64

Change from Baseline in Body Mass Index (BMI)

Change from Baseline in BMI

Time frame: Baseline, Week 64

Change in Medication Use

Time frame: Baseline, Week 64

Change from Baseline in SF-36v2 Acute Form Domain Scores With Exception of the Physical Functioning Domain Score

Time frame: Baseline, Week 64

Change from Baseline in Health Status EQ-5D-5L Health State Utility

Time frame: Baseline, Week 64

Percent Change from Baseline in Fasting Insulin

Time frame: Baseline, Week 64

Percent Change from Baseline in Total Cholesterol

Time frame: Baseline, Week 64

Change from Baseline in Waist Circumference

Time frame: Baseline, Week 64

Percent Change from Baseline in Hemoglobin A1c (HbA1c)

Percent Change from Baseline in HbA1c

Time frame: Baseline, Week 64

Change from Baseline in WOMAC Stiffness Subscale Score

Time frame: Baseline, Week 64

Change from Baseline in WOMAC Total Score

Time frame: Baseline, Week 64

Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Pain

Achievement of Improved Categorical Shift in PGIS - Target Knee Pain

Time frame: Baseline, Week 64

Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Function

Achievement of Improved Categorical Shift in PGIS - Target Knee Function

Time frame: Baseline, Week 64

Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score

Change from Baseline in API-NRS Score

Time frame: Baseline, Week 64

Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score

Change from Baseline in WPI-NRS Score

Time frame: Baseline, Week 64

Pharmacokinetics (PK): Maximum Concentration at Steady State (Cmax, ss)

PK: Cmax, ss

Time frame: Baseline through Week 64

PK: Area Under the Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-T)ss)

PK: AUC(0-T)ss

Time frame: Baseline through Week 64

Number of Participants with Allowed Concomitant Pain Medication

Time frame: Baseline, Week 64