A Study of Eloralintide (LY3841136) in Participants With Persistent Obesity Who Are Treated With a Weekly Incretin

NCT07392190
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
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Participants
900
clinicaltrials.gov
Lead sponsor
Eli Lilly and Company
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Start date
2026-02-10
clinicaltrials.gov
Number of sites
185
clinicaltrials.gov

Summary
The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo in participants with persistent obesity or overweight, with or without type 2 diabetes, and on stable incretin background therapy. Participation in the study will last about 80 weeks.
clinicaltrials.gov
Acronym
ENLIGHTEN-6
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Short title
A Study of Eloralintide (LY3841136) in Participants With Persistent Obesity Who Are Treated With a Weekly Incretin
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 Persistent Obesity or Overweight Treated With a Weekly Incretin, With and Without Type 2 Diabetes
clinicaltrials.gov

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
2028-07-01
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First posted
2026-02-06
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Registry last updated
2026-09-22
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Primary completion date
2028-06-01
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Start date
2026-02-10
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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
185
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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
NCT07392190
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ClinicalTrials.gov ID
NCT07392190
clinicaltrials.gov
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

  1. Change from Baseline in Waist Circumference

    Timeframe: Baseline, Week 64

  2. Percent Change in Baseline in Triglycerides

    Timeframe: Baseline, Week 64

  3. Change from Baseline in Systolic Blood Pressure

    Timeframe: Baseline, Week 64

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

    Timeframe: Baseline, Week 64

  5. Change from Baseline in Fasting Glucose in Participants with Type 2 Diabetes at Baseline

    Timeframe: Baseline, Week 64

  6. Change from Baseline in Short Form-36 (SF-36 v2) Score

    Timeframe: Baseline, Week 64

  7. Change from Baseline in EQ-5D-5L Score

    Timeframe: Baseline, Week 64

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

    Timeframe: Baseline, Week 64

  9. Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) Physical Function Weight

    Timeframe: Baseline, Week 64

  10. Percent Change from Baseline in Fasting Insulin

    Timeframe: Baseline, Week 64

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

    Timeframe: Baseline, Week 64

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

    Timeframe: Baseline, Week 64

  13. Change in Medication Use

    Timeframe: Baseline through Week 64

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

    Timeframe: Baseline through Week 64

  15. 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

  • Are on stable incretin therapy at screening

  • With persistent obesity or overweight defined as:

    • ≥30 kg/m2 OR

    • ≥27 kg/m2 with at least one existing obesity related complication at screening:

      • hypertension
      • dyslipidemia
      • obstructive sleep apnea
      • cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure), or
      • type 2 diabetes

  • Have a stable body weight (<5% body weight change) at screening

  • 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

  • Have taken any of the following antihyperglycemic medications within 90 days before screening:

    • dipeptidyl peptidase-4 (DPP-4) inhibitors
    • amylin analogs
    • insulin

  • 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

Sources for eligibility
clinicaltrials.gov

  • Birmingham Clinical ResearchBirmingham, United StatesRecruiting
  • RIO Clinical Trials - PhoenixPhoenix, United StatesRecruiting
  • Headlands Research - ScottsdaleScottsdale, United StatesRecruiting
  • Novak Clinical Research - Tucson - North La Cholla BoulevardTucson, United StatesRecruiting
  • Irvine Clinical ResearchIrvine, United StatesRecruiting
  • Scripps Whittier Diabetes InstituteLa Jolla, United StatesRecruiting
  • EndoTrials Center for Clinical ResearchLa Mesa, United StatesNot yet recruiting
  • Peninsula Research AssociatesRolling Hills Estates, United StatesRecruiting
  • Care Access - SacramentoSacramento, United StatesNot yet recruiting
  • Artemis Institute for Clinical ResearchSan Diego, United StatesRecruiting
  • Southern California Clinical ResearchSanta Ana, United StatesRecruiting
  • University Clinical Investigators, Inc.Tustin, United StatesRecruiting
  • New England Research Associates, LLCBridgeport, United StatesRecruiting
  • Yale University School of MedicineNew Haven, United StatesRecruiting
  • Chase Medical Research, LLCWaterbury, United StatesRecruiting
  • JEM Research InstituteAtlantis, United StatesRecruiting
  • AMR ClinicalDoral, United StatesRecruiting
  • Northeast Research Institute (NERI)Fleming Island, United StatesRecruiting
  • Jacksonville Center for Clinical ResearchJacksonville, United StatesRecruiting
  • New Horizon Research CenterMiami, United StatesRecruiting
  • St Johns Center for Clinical ResearchSaint Augustine, United StatesRecruiting
  • Metabolic Research Institute, Inc.West Palm Beach, United StatesRecruiting
  • Teak Research Consults - DunwoodyDunwoody, United StatesRecruiting
  • Center for Advanced Research & EducationGainesville, United StatesRecruiting
  • Clinical Research AtlantaStockbridge, United StatesRecruiting

And 160 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-523659-73-00
  • J3R-MC-YDAL
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)