ENLIGHTEN-1

RecruitingPhase 3

A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Obesity or Overweight, Without Type 2 Diabetes

Lead sponsor

Eli Lilly and Company

Asset

Eloralintide

Subcutaneous · Amylin analog

Listed sites

170

Recruiting sites

Enrollment

1,980

estimated

Study population

Obesity / overweight, Prediabetes / glucose intolerance

Key I/E criterion

—

Primary endpoint

•Body weight, % change

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 IDNCT07321886

Org study ID27742

Secondary ID2025-523657-34-00EU CTIS

Secondary IDJ3R-MC-YDAGEli Lilly and Company

Timeline

Milestones

Study first posted2026-01-07actual

Study start2026-02-06actual

Last update posted2026-05-22actual

Primary completion2028-03estimated (month precision)

Study completion2030-07estimated (month precision)

Assets

Investigational agents

Eloralintide

Study populations

Who this study enrolls

Obesity / overweightPrediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have Body Mass Index (BMI) at screening of the following:

–30 kilogram per square meter (kg/m2) OR

–27 kg/m2 with at least one of the following weight-related health conditions at screening:

–high blood pressure

–dyslipidemia

–obstructive sleep apnea, or

–heart disease

•Have a stable body weight (<5% body weight change) for 90 days prior to screening.

•Have a history of at least one self-reported unsuccessful dietary effort to reduce body weight

Exclusion criteria

•Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed >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 or type 2 diabetes

•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 (19)

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

Weight & body composition

Patient-reported / QoL

Glycemic / diabetes

Cardiometabolic biomarkers

Safety / tolerability / PK

Renal / kidney

Other (unclassified)

Weight & body composition

5 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

Percent Change from Baseline in Total Body Fat Mass

Time frame:Baseline, Week 64

Total fat mass

percent 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

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

Percent Change from Baseline in Body Weight in Participants with Prediabetes at Randomization

Time frame:Baseline, Week 168

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Time to Onset of Type 2 Diabetes (T2D)

Time frame:Baseline to Week 168 and Week 191

Time to T2DM onset

time to event, event

Secondary/protocol endpoint

Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 64

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percent Change from Baseline in Fasting Insulin

Time frame:Baseline, Week 64

percent change from baseline, improvement

Renal / kidney

1 endpoint

Secondary/protocol endpoint

Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)

Time frame:Baseline, Week 64

eGFR, change

change from baseline, improvement

LOINC 98979-8

Cardiometabolic biomarkers

3 endpoints

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

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 High-Sensitivity C-Reactive Protein (hsCRP)

Time frame:Baseline, Week 64

hs-CRP, change

percent change from baseline, improvement

LOINC 30522-7

Patient-reported / QoL

4 endpoints

Secondary/protocol endpoint

Change from Baseline in Short Form-36 Version 2 (SF-36 v2) Score

Time frame:Baseline, Week 64

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in EQ-5D-5L

Time frame:Baseline, Week 64

EQ-5D index

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Control of Eating Questionnaire (CoEQ) Score

Time frame:Baseline, Week 64

change from baseline, improvement

Secondary/protocol endpoint

Achievement of Improved Categorical Shift in Patient Global Improvement of Status (PGIS) Physical Function Weight

Time frame:Baseline, Week 64

PGI, change

threshold achievement, improvement

Safety / tolerability / PK

2 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-ᴛ)ss)

Time frame:Baseline through Week 64

AUC₀–∞

concentration, descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change in Medication Use

Time frame:Baseline through 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.