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

NCT07321886
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
1,980
clinicaltrials.gov
Lead sponsor
Eli Lilly and Company
clinicaltrials.gov
Start date
2026-02-06
clinicaltrials.gov
Number of sites
162
clinicaltrials.gov

Summary
The purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes. The study has two phases: a main phase and an extension phase. Participation in the main phase of the study will last about 75 weeks. Participants with prediabetes will continue in the extension phase for another 2 years.
clinicaltrials.gov
Acronym
ENLIGHTEN-1
clinicaltrials.gov
Short title
A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes
clinicaltrials.gov
Official title
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
clinicaltrials.gov

Control arm
Placebo
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2030-07-01
clinicaltrials.gov
First posted
2026-01-07
clinicaltrials.gov
Registry last updated
2026-08-21
clinicaltrials.gov
Primary completion date
2028-03-01
clinicaltrials.gov
Start date
2026-02-06
clinicaltrials.gov

Participants
1,980
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
1,980
clinicaltrials.gov
Protocol amendments
0
clinicaltrials.gov
Number of sites
162
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Eli Lilly and Company
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07321886
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07321886
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

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

  1. Percent Change from Baseline in Total Body Fat Mass

    Timeframe: Baseline, Week 64

  2. Change from Baseline in Waist Circumference

    Timeframe: Baseline, Week 64

  3. Percent Change from Baseline in Triglycerides

    Timeframe: Baseline, Week 64

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

    Timeframe: Baseline, Week 64

  5. Time to Onset of Type 2 Diabetes (T2D)

    Timeframe: Baseline to Week 168 and Week 191

    Time to Onset of Type 2 Diabetes (T2D) in Participants with Prediabetes at Randomization

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

    Timeframe: Baseline, Week 64

  7. Change from Baseline in Hemoglobin A1c (HbA1c)

    Timeframe: Baseline, Week 64

  8. Percent Change from Baseline in Fasting Insulin

    Timeframe: Baseline, Week 64

  9. Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)

    Timeframe: Baseline, Week 64

  10. Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)

    Timeframe: Baseline, Week 64

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

    Timeframe: Baseline, Week 64

  12. Change from Baseline in EQ-5D-5L

    Timeframe: Baseline, Week 64

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

    Timeframe: Baseline, Week 64

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

    Timeframe: Baseline, Week 64

  15. Change in Medication Use

    Timeframe: Baseline through Week 64

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

    Timeframe: Baseline, Week 168

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

    Timeframe: Baseline through Week 64

  18. PK: Area Under the Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-ᴛ)ss)

    Timeframe: Baseline through Week 64

Sources for outcomes
clinicaltrials.gov

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

  • 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

  • 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

Sources for eligibility
clinicaltrials.gov

  • MFA Clinical ResearchTuscaloosa, United StatesRecruiting
  • Headlands Research - ScottsdaleScottsdale, United StatesRecruiting
  • Neighborhood Healthcare Institute of HealthEscondido, United StatesRecruiting
  • Ark Clinical Research - Fountain ValleyFountain Valley, United StatesRecruiting
  • Desert Oasis Healthcare Medical GroupPalm Springs, United StatesRecruiting
  • Peninsula Research AssociatesRolling Hills Estates, United StatesRecruiting
  • Care Access - SacramentoSacramento, United StatesRecruiting
  • Southern California Clinical ResearchSanta Ana, United StatesRecruiting
  • University Clinical Investigators, Inc.Tustin, United StatesRecruiting
  • Chase Medical Research, LLCWaterbury, United StatesRecruiting
  • JEM Research InstituteAtlantis, United StatesRecruiting
  • BioMed Research & Medical CenterMiami, United StatesRecruiting
  • Adult Medicine of Lake County, Inc.Mt. Dora, United StatesRecruiting
  • American Research Centers of FloridaPembroke Pines, United StatesRecruiting
  • AHF PensacolaPensacola, United StatesRecruiting
  • IMA Clinical Research St. PetersburgSt. Petersburg, United StatesRecruiting
  • Teak Research Consults - DunwoodyDunwoody, United StatesRecruiting
  • Teak Research ConsultsLawrenceville, United StatesRecruiting
  • Clinical Research AtlantaStockbridge, United StatesRecruiting
  • East-West Medical Research InstituteHonolulu, United StatesRecruiting
  • Iowa Diabetes and Endocrinology Research CenterWest Des Moines, United StatesRecruiting
  • Cotton O'Neil Clinical Research CenterTopeka, United StatesRecruiting
  • Care Access - Lake Charles (Bayou Pines)Lake Charles, United StatesRecruiting
  • MedStar Good Samaritan HospitalBaltimore, United StatesRecruiting
  • MedStar Health Research Institute (MedStar Physician Based Research Network)Hyattsville, United StatesRecruiting

And 137 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-523657-34-00
  • J3R-MC-YDAG
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)