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.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 900 (estimated) |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 147 sites (Mobile, Alabama and 146 other locations) |
| Status | Recruiting |
| Started | February 9, 2026 |
| Main results expected | March 2028 |
| Study ends | May 2028 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07353931 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
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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
Show 44 more locations
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Wolverine Clinical Trials
Santa Ana, California, United States Recruiting -
Encompass Clinical Research
Spring Valley, California, United States Recruiting -
Diablo Clinical Research, Inc.
Walnut Creek, California, United States Recruiting -
Skylight Health Research - Colorado Springs
Colorado Springs, Colorado, United States Recruiting -
Westside Center for Clinical Research
Jacksonville, Florida, United States Recruiting -
Care Access - St. Petersburg
St. Petersburg, Florida, United States Recruiting -
Conquest Research
Winter Park, Florida, United States Recruiting -
Orita Clinical Research
Decatur, Georgia, United States Recruiting -
North Georgia Clinical Research
Woodstock, Georgia, United States Recruiting -
Medical Research Partners
Ammon, Idaho, United States Recruiting -
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, United States Recruiting -
Qualmedica Research, LLC
Evansville, Indiana, United States Recruiting -
AMR Clinical
Newton, Kansas, United States Recruiting -
Monroe Biomedical Research - Louisville
Louisville, Kentucky, United States Recruiting -
Skylight Health Research - Burlington
Burlington, Massachusetts, United States Recruiting -
Care Access - Quincy
Quincy, Massachusetts, United States Recruiting -
Ellipsis Research Group - Brooklyn - 7th Street
Brooklyn, New York, United States Recruiting -
Rochester Clinical Research - Buffalo
Buffalo, New York, United States Recruiting -
NYC Research INC
Long Island City, New York, United States Recruiting -
Rochester Clinical Research, LLC
Rochester, New York, United States Recruiting -
Central States Research
Tulsa, Oklahoma, United States Recruiting -
Keystone Clinical Studies
Plymouth Meeting, Pennsylvania, United States Recruiting -
JCCT - Juno Bellaire Site
Bellaire, Texas, United States Recruiting -
Epic Medical Research - DeSoto
DeSoto, Texas, United States Recruiting -
Valley Institute of Research - Fort Worth
Fort Worth, Texas, United States Recruiting -
Care Access - Houston
Houston, Texas, United States Recruiting -
VIP Trials
San Antonio, Texas, United States Recruiting -
Endeavor Clinical Trials
San Antonio, Texas, United States Recruiting -
Consano Clinical Research, LLC
Shavano Park, Texas, United States Recruiting -
Texas Valley Clinical Research
Weslaco, Texas, United States Recruiting -
AMR Clinical
South Jordan, Utah, United States Recruiting -
Charlottesville Medical Research
Charlottesville, Virginia, United States Recruiting -
Paramount Clinical Research - Data Point Clinical Research
Kirkland, Washington, United States Recruiting -
Antwerp University Hospital
Edegem, Belgium Recruiting -
Reuma Clinic, Locatie Jaarbeurslaan
Genk, Belgium Recruiting -
UZ Gent
Ghent, Belgium Recruiting -
Kormont
Kluisbergen, Belgium Recruiting -
UZ Leuven
Leuven, Belgium Recruiting -
Meclinas
Mechelen, Belgium Recruiting -
ZNA Jan Palfijn
Merksem, Belgium Recruiting -
Apex Trials
Guelph, Canada Recruiting -
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
Québec, Canada Recruiting -
Diex Recherche Inc. Division Quebec
Québec, Canada Recruiting -
Stouffville Medical Research Institute Inc.
Stouffville, Canada Recruiting
+97 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 317-615-4559
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.