DelfaGLP-1 Atlas

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ENLIGHTEN-4

RecruitingPhase 3

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

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)

Asset

Eloralintide

Subcutaneous · Amylin analog

Listed sites

160

Recruiting sites

66

Enrollment

900

estimated

Study population

Obesity / overweight, Osteoarthritis

Key I/E criterion

—

Primary endpoints

•Body weight, % change•WOMAC pain

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07353931
Org study ID27761
Secondary ID2025-523768-19-00
Secondary IDJ3R-MC-YDANEli Lilly and Company
Secondary IDJ3R-MC-YOA1Eli Lilly and Company
Secondary IDJ3R-MC-YOA2Eli Lilly and Company

Timeline

Milestones

Study first posted2026-01-21actual
Study start2026-02-09actual
Last update posted2026-05-22actual
Primary completion2028-03estimated (month precision)
Study completion2028-05estimated (month precision)

Assets

Investigational agents

Eloralintide

Study populations

Who this study enrolls

Obesity / overweightOsteoarthritis

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (26)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
7
Patient-reported / QoL
5
Cardiometabolic biomarkers
4
Weight & body composition
3
Safety / tolerability / PK
3
Glycemic / diabetes
2
Heart failure
1
Other (unclassified)
1

Weight & body composition

3 endpoints
Primary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, Week 64

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 64

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline, Week 64

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint/low confidence

Percent Change from Baseline in Fasting Insulin

Time frame:Baseline, Week 64

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 64

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Heart failure

1 endpoint
Secondary/protocol endpoint

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

Time frame:Baseline, Week 64

6-minute walk distance

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure (SBP)

Time frame:Baseline, Week 64

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Percent Change from Baseline in Triglycerides

Time frame:Baseline, Week 64

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

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

Time frame:Baseline, Week 64

hs-CRP, change

percent change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Percent Change from Baseline in Total Cholesterol

Time frame:Baseline, Week 64

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Patient-reported / QoL

5 endpoints
Secondary/protocol endpoint

Change from Baseline in Short Form-36 (SF-36 v2) Acute Form Physical Functioning Domain Score

Time frame:Baseline, Week 64

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

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, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 64

EQ-5D index

change from baseline, improvement

Secondary/protocol endpoint

Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Pain

Time frame:Baseline, Week 64

PGI, change

threshold achievement, improvement

Secondary/protocol endpoint

Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Function

Time frame:Baseline, Week 64

PGI, change

threshold achievement, improvement

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

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

Time frame:Baseline through Week 64

Cmax

concentration, descriptive

Secondary/protocol endpoint

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

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Number of Participants with Allowed Concomitant Pain Medication

Time frame:Baseline, Week 64

descriptive

Other clinical outcomes

7 endpoints
Primary/protocol endpoint

Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score

Time frame:Baseline, Week 64

WOMAC pain

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in the WOMAC Physical Function Subscale Score

Time frame:Baseline, Week 40, Week 64

WOMAC function

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline WOMAC Pain Subscale Score

Time frame:Baseline, Week 40

WOMAC pain

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in WOMAC Stiffness Subscale Score

Time frame:Baseline, Week 64

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in WOMAC Total Score

Time frame:Baseline, Week 64

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score

Time frame:Baseline, Week 64

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 64

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change in Medication Use

Time frame:Baseline, Week 64

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.