RecruitingPhase 3

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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

Two separate studies will test how well eloralintide (LY3841136) works and how safe it is. They are for adults with obesity or overweight who have knee pain from osteoarthritis, a disease that wears down joints. Taking part lasts about 75 weeks, including screening.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a BMI of 27 or higher at screening. BMI is a measure based on height and weight.
  • Have had less than a 5% change in body weight during the 90 days before screening.
  • Have tried to lose weight through diet at least once without success.
  • Have knee osteoarthritis and at least one of these: be over age 50, have morning knee stiffness lasting about 30 minutes, or have a crackling or grinding sound or feeling in the knee.

Who can't join

  • Have had or plan to have surgery for obesity. Liposuction, fat freezing, or a tummy tuck is allowed if done more than 1 year before screening.
  • Have had or plan to have an obesity treatment using a scope or device. Past device treatment is allowed if the device was removed more than 6 months before screening.
  • Have any type of diabetes.
  • Have a current knee infection.
  • In the 90 days before screening, had a heart attack, stroke, procedure to restore blood flow to the heart, unstable angina (new or worsening heart-related chest pain), or a hospital stay for heart failure.
  • Have or have had Class IV heart failure, the most severe class of heart failure.
  • Have used medicines or alternative remedies meant for weight loss within 90 days of screening.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (39)

AL

AZ

  • Care Access - 801 South Power Road, Mesa · Mesa, AZ 85206 · Study contact · 877-791-0656Michael Waters · Principal investigatorMore trials in Mesa
  • Elite Pain and Spine Institute - South Crimson Road · Mesa, AZ 85209Zeeshan Malik · Principal investigatorMore trials in Mesa
  • Elite Clinical Studies, LLC · Phoenix, AZ 85018 · Study contact · 602-788-3437Joseph Lillo, DO · Principal investigatorMore trials in Phoenix
  • Tucson Orthopaedic Institute - North Wyatt Drive · Tucson, AZ 85712 · Study contact · 520-404-0276Nebojsa Skrepnik · Principal investigatorMore trials in Tucson

CA

CO

FL

GA

ID

IL

IN

KS

KY

MA

NY

OK

PA

TX

UT

VA

WA