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Eloralintide for knee osteoarthritis pain in adults with overweight or obesity

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)

Phase 3 Interventional Eli Lilly and Company · NCT07353931

This trial tests whether eloralintide reduces knee osteoarthritis pain in adults who are overweight or have obesity.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment900 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations154 sites (Mobile, Alabama and 153 other locations)
Trial IDNCT07353931 on ClinicalTrials.gov

What this trial studies

Under a master protocol, two parallel Phase 3 studies will compare eloralintide to placebo in adults with knee osteoarthritis who are overweight or have obesity. Eligible participants with a BMI of 27 kg/m² or higher and qualifying knee symptoms will be enrolled and followed for about 75 weeks, including screening. The studies will collect measures of knee pain, physical function, weight change, and safety outcomes. Safety monitoring will include adverse event reporting and laboratory assessments throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults with a BMI of 27 kg/m² or higher who have symptomatic knee osteoarthritis, have tried and not succeeded at weight loss, and have had stable body weight for the prior 90 days.

Not a fit: People with any type of diabetes, an active knee infection, or recent or planned surgical or device-based obesity treatments are excluded and would not be expected to benefit from participation.

Why it matters

Potential benefit: If successful, eloralintide could reduce knee pain and improve function for people with osteoarthritis who are overweight or have obesity.

How similar studies have performed: Weight-loss approaches have shown promise for improving knee osteoarthritis symptoms in prior studies, but eloralintide itself is a newer agent with limited published phase 3 results to date.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Mobile, Alabama and 153 other locations

+104 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions OsteoarthritisOverweight or Obesity
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.