> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-of-eloralintide-ly3841136-in-5421cc92-19db-4853-876e-4809ed4048c2 > Record changed: 2026-11-04 # Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain and Obesity or Overweight NCT07353931 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) Participants 900 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) Start date 2026-02-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) Number of sites 153 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) **Acronym** ENLIGHTEN-4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) **Short title** Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain and Obesity or Overweight Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) ## Dates **Completion date** 2028-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) **First posted** 2026-01-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) **Registry last updated** 2026-10-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) **Primary completion date** 2028-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) **Start date** 2026-02-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) ## Size and sites **Participants** 900 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) **Planned participants** 900 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) **Number of sites** 153 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) ## Identifiers **Registry ID** NCT07353931 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) **ClinicalTrials.gov ID** NCT07353931 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) ## Outcomes ### Primary outcomes 1. Percent Change from Baseline in Body Weight Timeframe: Baseline, Week 64 Percent Change from Baseline in Body Weight 2. Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Timeframe: Baseline, Week 64 Change from Baseline in the WOMAC Pain Subscale Score ### Secondary outcomes 1. Change from Baseline in Systolic Blood Pressure (SBP) Timeframe: Baseline, Week 64 Change from Baseline in SBP 2. Percent Change from Baseline in Triglycerides Timeframe: Baseline, Week 64 Percent Change in Baseline in Triglycerides 3. Change from Baseline in Short Form-36 (SF-36 v2) Acute Form Physical Functioning Domain Score Timeframe: Baseline, Week 64 Change from Baseline in SF-36 v2 Score 4. Percent Change from Baseline in High Sensitivity, C-reactive Protein (hsCRP) Timeframe: Baseline, Week 64 Percent Change from Baseline in hsCRP 5. Change from Baseline in the WOMAC Physical Function Subscale Score Timeframe: Baseline, Week 40, Week 64 Change from Baseline in the WOMAC Physical Function Subscale Score 6. Change from Baseline WOMAC Pain Subscale Score Timeframe: Baseline, Week 40 Change from Baseline WOMAC Pain Subscale Score 7. Change from Baseline in Distance Walked During the 6-Minute Walk Test Timeframe: Baseline, Week 64 Change from Baseline in Distance Walked During the 6-Minute Walk Test 8. Change from Baseline in Body Mass Index (BMI) Timeframe: Baseline, Week 64 Change from Baseline in BMI 9. Change in Medication Use Timeframe: Baseline, Week 64 Change in Medication Use 10. Change from Baseline in SF-36v2 Acute Form Domain Scores With Exception of the Physical Functioning Domain Score Timeframe: Baseline, Week 64 Change from Baseline in SF-36v2 Acute Form Domain Scores With Exception of the Physical Functioning Domain Score 11. Change from Baseline in Health Status EQ-5D-5L Health State Utility Timeframe: Baseline, Week 64 Change from Baseline in Health Status EQ-5D-5L Health State Utility 12. Percent Change from Baseline in Fasting Insulin Timeframe: Baseline, Week 64 Percent Change from Baseline in Fasting Insulin 13. Percent Change from Baseline in Total Cholesterol Timeframe: Baseline, Week 64 Percent Change from Baseline in Total Cholesterol 14. Change from Baseline in Waist Circumference Timeframe: Baseline, Week 64 Change from Baseline in Waist Circumference 15. Percent Change from Baseline in Hemoglobin A1c (HbA1c) Timeframe: Baseline, Week 64 Percent Change from Baseline in HbA1c 16. Change from Baseline in WOMAC Stiffness Subscale Score Timeframe: Baseline, Week 64 Change from Baseline in WOMAC Stiffness Subscale Score 17. Change from Baseline in WOMAC Total Score Timeframe: Baseline, Week 64 Change from Baseline in WOMAC Total Score 18. Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Pain Timeframe: Baseline, Week 64 Achievement of Improved Categorical Shift in PGIS - Target Knee Pain 19. Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Function Timeframe: Baseline, Week 64 Achievement of Improved Categorical Shift in PGIS - Target Knee Function 20. Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score Timeframe: Baseline, Week 64 Change from Baseline in API-NRS Score 21. Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score Timeframe: Baseline, Week 64 Change from Baseline in WPI-NRS Score 22. Pharmacokinetics (PK): Maximum Concentration at Steady State (Cmax, ss) Timeframe: Baseline through Week 64 PK: Cmax, ss 23. PK: Area Under the Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-T)ss) Timeframe: Baseline through Week 64 PK: AUC(0-T)ss 24. Number of Participants with Allowed Concomitant Pain Medication Timeframe: Baseline, Week 64 Number of Participants with Allowed Concomitant Pain Medication Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) ## Sites - AMR ClinicalMobile, United StatesRecruiting - Care Access - 801 South Power Road, MesaMesa, United StatesRecruiting - Elite Pain and Spine Institute - South Crimson RoadMesa, United StatesRecruiting - Elite Clinical Studies, LLCPhoenix, United StatesRecruiting - Tucson Orthopaedic Institute - North Wyatt DriveTucson, United StatesRecruiting - Ark Clinical Research - Fountain ValleyFountain Valley, United StatesRecruiting - Wolverine Clinical TrialsSanta Ana, United StatesRecruiting - Encompass Clinical ResearchSpring Valley, United StatesRecruiting - Diablo Clinical Research, Inc.Walnut Creek, United StatesRecruiting - Skylight Health Research - Colorado SpringsColorado Springs, United StatesRecruiting - Westside Center for Clinical ResearchJacksonville, United StatesRecruiting - Care Access - St. PetersburgSt. Petersburg, United StatesRecruiting - Conquest ResearchWinter Park, United StatesRecruiting - Orita Clinical ResearchDecatur, United StatesRecruiting - North Georgia Clinical ResearchWoodstock, United StatesNot yet recruiting - Medical Research PartnersAmmon, United StatesRecruiting - Great Lakes Clinical Trials - RavenswoodChicago, United StatesRecruiting - Qualmedica Research, LLCEvansville, United StatesRecruiting - AMR ClinicalNewton, United StatesRecruiting - Monroe Biomedical Research - LouisvilleLouisville, United StatesRecruiting - Skylight Health Research - BurlingtonBurlington, United StatesRecruiting - Care Access - QuincyQuincy, United StatesRecruiting - Ellipsis Research Group - Brooklyn - 7th StreetBrooklyn, United StatesRecruiting - Rochester Clinical Research - BuffaloBuffalo, United StatesRecruiting - NYC Research INCLong Island City, United StatesRecruiting And 128 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/660855) ### Other registry identifiers (3) - 2025 - 2025-523768-19-00 - J3R-MC-YDAN Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07353931) ## Related records ### Drugs (1) - [Eloralintide](https://trialight.com/data/asset/eloralintide-ccf70d16-4bb8-42b3-b3e3-491d8fbd44a8.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (2) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) - [Osteoarthritis](https://trialight.com/data/condition/osteoarthritis-e8c428fb-1597-576d-bcf0-f3b27ebc6a00.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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