Clinical trial Recruiting at 132 sites Phase 3 Interventional Ages 18 and up

Eloralintide for knee osteoarthritis pain in adults with overweight or obesity

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)

Run by Eli Lilly and Company · NCT07353931 · Data updated 2026-11-12

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

More Osteoarthritis trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment900 (estimated)
SponsorEli Lilly and Company
Industry-sponsored
Locations147 sites (Mobile, Alabama and 146 other locations)
StatusRecruiting
StartedFebruary 9, 2026
Main results expectedMarch 2028
Study endsMay 2028
Registry record updatedNovember 4, 2026
Trial IDNCT07353931 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • AMR Clinical
    Mobile, Alabama, United States
    Recruiting
  • Care Access - 801 South Power Road, Mesa
    Mesa, Arizona, United States
    Recruiting
  • Elite Pain and Spine Institute - South Crimson Road
    Mesa, Arizona, United States
    Recruiting
  • Elite Clinical Studies, LLC
    Phoenix, Arizona, United States
    Recruiting
  • Tucson Orthopaedic Institute - North Wyatt Drive
    Tucson, Arizona, United States
    Recruiting
  • Ark Clinical Research - Fountain Valley
    Fountain Valley, California, United States
    Recruiting
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    Brooklyn, New York, United States
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+97 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 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.