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

NCT07353931
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
900
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Lead sponsor
Eli Lilly and Company
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Start date
2026-02-09
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Number of sites
153
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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.
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Acronym
ENLIGHTEN-4
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Short title
Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain and Obesity or Overweight
clinicaltrials.gov
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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2028-05-01
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First posted
2026-01-21
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Registry last updated
2026-10-08
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Primary completion date
2028-03-01
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Start date
2026-02-09
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Participants
900
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Participant count basis
Estimated
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Planned participants
900
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Protocol amendments
0
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Number of sites
153
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07353931
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ClinicalTrials.gov ID
NCT07353931
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

  • 2025
  • 2025-523768-19-00
  • J3R-MC-YDAN
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)