Eloralintide for knee osteoarthritis pain in adults who are overweight or have obesity
Tests eloralintide against placebo in adults with painful knee osteoarthritis and excess weight.
Key facts
- Who runs it
- Eli Lilly and Company
- Where
- Dorado and San Juan, Puerto RicoSee the 2 sitesAlso in 12 other countries, 144 sites
- Trial code
- NCT07353931
- EU 2025-523768-19-00
- U1111-1330-5442
- Registry title
- Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain and Obesity or Overweight
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 900 people, planned
- Started
- 9 Feb 2026
- Expected to end
- May 2028
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Eloralintide
- Placebo
- Record updated
- 4 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with knee osteoarthritis pain who also have overweight or obesity (BMI of 27 kg/m² or higher) and have not lost weight through diet.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Osteoarthritis of the knee with pain, and at least one of: over 50 years old, morning knee stiffness lasting about 30 minutes, or a crackling or grinding feeling in the knee.
- Earlier treatment
- Must have tried at least once to lose weight through diet without success. Must not have taken weight-loss medications or alternative remedies within 90 days of screening.
- Biomarker or test result
- BMI of 27 kg/m² or higher at screening; stable body weight (less than 5% change) for 90 days before screening.
Main reasons for not taking part
- Any type of diabetes (type 1, type 2 or other)
- Surgery or endoscopic or device-based treatment for obesity (some exceptions if long ago)
- Active knee infection
- Heart attack, stroke, coronary artery revascularization, unstable angina or hospitalization for heart failure within 90 days before screening
- Class IV congestive heart failure (New York Heart Association)
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 had within 90 days prior to screening:; heart attack; stroke; coronary artery revascularization; unstable angina, or; hospitalization due to congestive heart failure
- Have taken medications or alternative remedies intended for weight loss within 90 days of screening
- Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
- Have an active knee infection
- Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure
Where in Puerto Rico
Also in 12 other countries, 144 sites
- Dorado Medical ComplexDorado, Puerto RicoContact: Luis Pagan-Cardona (principal investigator)Taking people
- GCM Medical Group, PSC - Hato Rey SiteSan Juan, Puerto RicoContact: Karina Vila-Rivera (principal investigator)Taking people
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Eloralintide (YOA1)Treatment being tested
Participants will receive eloralintide subcutaneously (SC)
Treatment: Eloralintide
- Placebo (YOA1)Placebo, for comparison
Participants will receive placebo SC
Treatment: Placebo
- Eloralintide (YOA2)Treatment being tested
Participants will receive eloralintide SC
Treatment: Eloralintide
- Placebo (YOA2)Placebo, for comparison
Participants will receive placebo SC
Treatment: Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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)
- Plain-language title
- Eloralintide for knee osteoarthritis pain in adults who are overweight or have obesityGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 4 November 2026