Recruiting NCT07353931

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

Phase III Interventional Osteoarthritis Overweight or Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Eloralintide, Placebo.
Who it may be relevant to: Registry conditions: Osteoarthritis, Overweight or Obesity. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Belgium, Brazil, Canada +9
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Osteoarthritis Knee Pain, and Obesity or Overweight (ENLIGHTEN-4)

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.

Interventions

Drug Eloralintide
Administered SC
Drug Placebo
Placebo administered SC

Primary outcome measures

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 [Time frame: Baseline, Week 64]

Secondary outcome measures (12)

Change from Baseline in Systolic Blood Pressure (SBP) [Time frame: Baseline, Week 64]
Percent Change from Baseline in Triglycerides [Time frame: Baseline, Week 64]
Change from Baseline in Short Form-36 (SF-36 v2) Acute Form Physical Functioning Domain Score [Time frame: Baseline, Week 64]
Percent Change from Baseline in High Sensitivity, C-reactive Protein (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 [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) [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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment

Study locations

United States · 38 centers

AMR Clinical — Mobile
Care Access - 801 South Power Road, Mesa — Mesa
Elite Pain and Spine Institute - South Crimson Road — Mesa
Elite Clinical Studies, LLC — Phoenix
Tucson Orthopaedic Institute - North Wyatt Drive — Tucson
Ark Clinical Research - Fountain Valley — Fountain Valley
Wolverine Clinical Trials — Santa Ana
Encompass Clinical Research — Spring Valley
… and 30 more centers

China · 23 centers

Beijing Ji Shui Tan Hospital — Beijing
The First Afflilated Hospital of Bengbu Medical College — Bengbu
Jilin Province People's Hospital — Changchun
The Second Hospital of Jilin University — Changchun
Xiangya Hospital Central South University — Changsha
2nd Affiliated Hospital Chongqing Medical Universi — Chongqing
The Second Affiliated hospital of Zhejiang University school of medicine — Hangzhou
… and 16 more centers

Japan · 15 centers