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

NCT ID
NCT07353931
Registry status
Recruiting
Study type
Interventional
Phase
Phase 3
Sponsor
Eli Lilly and Company
Conditions
Osteoarthritis, Overweight or Obesity

Overview

ClinicalTrials.gov lists this study as Recruiting.

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)

Enrollment: 900 participants (Estimated).

What is being studied

  • Drug: Eloralintide
  • Drug: Placebo

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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 locations

152 study locations are listed.

Recruiting site status is explicitly provided for 152 locations; 128 are listed as Recruiting.

Countries: Argentina, Belgium, Brazil, Canada, China, Czechia, Denmark, Germany, Japan, Puerto Rico, South Korea, Taiwan, United Kingdom, United States

  • Alabama, United States: 1
  • Arizona, United States: 4
  • California, United States: 4
  • Colorado, United States: 1
  • Florida, United States: 3
  • Georgia, United States: 1
  • Idaho, United States: 1
  • Illinois, United States: 1
  • Indiana, United States: 1
  • Kansas, United States: 1
  • Kentucky, United States: 1
  • Massachusetts, United States: 2
  • New York, United States: 4
  • Oklahoma, United States: 1
  • Pennsylvania, United States: 1
  • Texas, United States: 8
  • Utah, United States: 1
  • Virginia, United States: 1
  • Washington, United States: 1

Sample of listed locations

  • Antwerp University Hospital — Edegem, 2650, Belgium — Recruiting
  • Reuma Clinic, Locatie Jaarbeurslaan — Genk, 3600, Belgium — Recruiting
  • UZ Gent — Ghent, 9000, Belgium — Recruiting
  • Kormont — Kluisbergen, 9690, Belgium — Recruiting
  • UZ Leuven — Leuven, 3000, Belgium — Recruiting
  • Meclinas — Mechelen, 2800, Belgium — Recruiting
  • Apex Trials — Guelph, N1G 0B4, Canada — Recruiting
  • Diex Recherche Inc. Division Quebec — Québec, G1V 4T3, Canada — Recruiting
  • Stouffville Medical Research Institute Inc. — Stouffville, L4A 1H2, Canada — Recruiting
  • Dr. Anil K. Gupta Medicine Professional Corporation — Toronto, M9V 4B4, Canada — Recruiting
  • Maple Leaf Research — Toronto, M5G 1K2, Canada — Recruiting
  • Diex Recherche Inc. Division Victoriaville — Victoriaville, G6P 3Z8, Canada — Recruiting
  • Beijing Ji Shui Tan Hospital — Beijing, 100035, China — Recruiting
  • The First Afflilated Hospital of Bengbu Medical College — Bengbu, 233004, China — Recruiting
  • Jilin Province People's Hospital — Changchun, 130021, China — Recruiting
  • Xiangya Hospital Central South University — Changsha, 410008, China — Recruiting
  • 2nd Affiliated Hospital Chongqing Medical Universi — Chongqing, 400000, China — Recruiting
  • The Second Affiliated hospital of Zhejiang University school of medicine — Hangzhou, 310052, China — Recruiting
  • The Second People's Hospital of Hefei — Hefei, 230011, China — Recruiting
  • Jinan Central Hospital — Jinan, 250013, China — Recruiting
  • The First Affiliated Hospital of Henan University of Science &Technology — Luoyang, 471003, China — Recruiting
  • Jiangsu Province Hospital — Nanjing, 210029, China — Recruiting
  • Nanjing First Hospital — Nanjing, 210006, China — Recruiting
  • The Second Affiliated Hospital of Nanjing Medical University — Nanjing, 210011, China — Recruiting
  • Zhongda Hospital Southeast University — Nanjing, 210009, China — Recruiting

Study details

Start date
February 9, 2026
Primary completion date
March 1, 2028
Completion date
May 1, 2028
First posted
January 21, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07353931
Registry last updated
September 22, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT07353931 on ClinicalTrials.gov

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