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NCT Number: NCT07353931

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

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.

Recruiting

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Key information

Conditions

Osteoarthritis Arthritis Body Weight Joint Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight or Obesity Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CARDIAMET Investigaciones Médicas, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eloralintide

Drug

Administered SC

Other names: LY3841136

Placebo

Drug

Placebo administered SC

Primary outcomes

  1. Percent Change from Baseline in Body Weight

    Time frame: 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

    Time frame: Baseline, Week 64

    Change from Baseline in the WOMAC Pain Subscale Score

Secondary outcomes

  1. Change from Baseline in Systolic Blood Pressure (SBP)

    Time frame: Baseline, Week 64

    Change from Baseline in SBP

  2. Percent Change from Baseline in Triglycerides

    Time frame: 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

    Time frame: Baseline, Week 64

    Change from Baseline in SF-36 v2 Score

  4. Percent Change from Baseline in High Sensitivity, C-reactive Protein (hsCRP)

    Time frame: Baseline, Week 64

    Percent Change from Baseline in hsCRP

  5. Change from Baseline in the WOMAC Physical Function Subscale Score

    Time frame: Baseline, Week 40, Week 64

    Change from Baseline in the WOMAC Physical Function Subscale Score

  6. Change from Baseline WOMAC Pain Subscale Score

    Time frame: Baseline, Week 40

    Change from Baseline WOMAC Pain Subscale Score

  7. Change from Baseline in Distance Walked During the 6-Minute Walk Test

    Time frame: Baseline, Week 64

    Change from Baseline in Distance Walked During the 6-Minute Walk Test

  8. Change from Baseline in Body Mass Index (BMI)

    Time frame: Baseline, Week 64

    Change from Baseline in BMI

  9. Change in Medication Use

    Time frame: 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

    Time frame: 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

    Time frame: Baseline, Week 64

    Change from Baseline in Health Status EQ-5D-5L Health State Utility

  12. Percent Change from Baseline in Fasting Insulin

    Time frame: Baseline, Week 64

    Percent Change from Baseline in Fasting Insulin

  13. Percent Change from Baseline in Total Cholesterol

    Time frame: Baseline, Week 64

    Percent Change from Baseline in Total Cholesterol

  14. Change from Baseline in Waist Circumference

    Time frame: Baseline, Week 64

    Change from Baseline in Waist Circumference

  15. Percent Change from Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, Week 64

    Percent Change from Baseline in HbA1c

  16. Change from Baseline in WOMAC Stiffness Subscale Score

    Time frame: Baseline, Week 64

    Change from Baseline in WOMAC Stiffness Subscale Score

  17. Change from Baseline in WOMAC Total Score

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Baseline, Week 64

    Change from Baseline in API-NRS Score

  21. Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score

    Time frame: Baseline, Week 64

    Change from Baseline in WPI-NRS Score

  22. Pharmacokinetics (PK): Maximum Concentration at Steady State (Cmax, ss)

    Time frame: 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)

    Time frame: Baseline through Week 64

    PK: AUC(0-T)ss

  24. Number of Participants with Allowed Concomitant Pain Medication

    Time frame: Baseline, Week 64

    Number of Participants with Allowed Concomitant Pain Medication

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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)

Acronym: ENLIGHTEN-4

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 21, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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