A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, and Type 2 Diabetes

NCT07282600
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,035
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Lead sponsor
Eli Lilly and Company
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Start date
2025-12-15
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Number of sites
159
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Summary
The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo for body weight reduction in participants with overweight or obesity and type 2 diabetes. Participation in the study will last about 75 weeks.
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Acronym
ENLIGHTEN-2
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Short title
A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, and Type 2 Diabetes
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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, and Type 2 Diabetes
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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
2028-02-01
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First posted
2025-12-15
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Registry last updated
2026-08-21
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Primary completion date
2028-01-01
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Start date
2025-12-15
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Participants
1,035
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Participant count basis
Estimated
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Planned participants
1,035
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Protocol amendments
0
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Number of sites
159
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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
NCT07282600
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ClinicalTrials.gov ID
NCT07282600
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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. 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. Change from Baseline in Hemoglobin A1c (HbA1c)

    Timeframe: Baseline, Week 64

  4. Percent Change in Baseline in Triglycerides

    Timeframe: Baseline, Week 64

  5. Change from Baseline in Systolic Blood Pressure

    Timeframe: Baseline, Week 64

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

    Timeframe: Baseline, Week 64

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

    Timeframe: Baseline, Week 64

  8. Percent Change from Baseline in Fasting Insulin

    Timeframe: Baseline, Week 64

  9. Change in Medication Use

    Timeframe: Baseline through Week 64

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

    Timeframe: Baseline, Week 64

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

    Timeframe: Baseline, Week 64

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

    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 Impression of Severity (PGIS) Physical Function Weight

    Timeframe: Baseline, Week 64

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

    Timeframe: Baseline through Week 64

  16. 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 type 2 diabetes
  • Are on stable treatment for type 2 diabetes for at least 90 days prior to screening
  • Have a BMI ≥ 27 kg/m2
  • Have a stable body weight (<5% body weight change) for 90 days prior to 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:

    • amylin analogs
    • glucagon-like peptide-1 (GLP-1) receptor agonists
    • glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 (GIP/GLP) receptor agonists, or
    • 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

  • Have taken medications or alternative remedies intended for weight loss within 90 days of screening

Sources for eligibility
clinicaltrials.gov

  • Birmingham Clinical ResearchBirmingham, United StatesRecruiting
  • Cullman Clinical TrialsCullman, United StatesRecruiting
  • Tucson Clinical Research InstituteTucson, United StatesRecruiting
  • San Fernando Valley Health InstituteCanoga Park, United StatesRecruiting
  • AMCR InstituteEscondido, United StatesRecruiting
  • NorCal Medical Research, IncGreenbrae, United StatesRecruiting
  • Ark Clinical ResearchLong Beach, United StatesRecruiting
  • Pacific Clinical StudiesLos Alamitos, United StatesRecruiting
  • Inglewood ClinicalLos Angeles, United StatesRecruiting
  • Care Access - Santa ClaritaSanta Clarita, United StatesRecruiting
  • Encompass Clinical ResearchSpring Valley, United StatesRecruiting
  • Diablo Clinical Research, Inc.Walnut Creek, United StatesRecruiting
  • Care Access - AuroraAurora, United StatesRecruiting
  • New England Research Associates, LLCBridgeport, United StatesRecruiting
  • CMR of Greater New Haven, LLCHamden, United StatesRecruiting
  • Arrow Clinical TrialsDaytona Beach, United StatesRecruiting
  • Care Access - Delray BeachDelray Beach, United StatesRecruiting
  • Fleming Island Center for Clinical ResearchFleming Island, United StatesRecruiting
  • Nature Coast Clinical Research - InvernessInverness, United StatesRecruiting
  • Jacksonville Center for Clinical ResearchJacksonville, United StatesRecruiting
  • Flourish Research Acquisition, LLC dba Flourish Research - North MiamiMiami, United StatesRecruiting
  • New Horizon Research CenterMiami, United StatesRecruiting
  • Adult Medicine of Lake County, Inc.Mt. Dora, United StatesRecruiting
  • American Research Centers of FloridaPembroke Pines, United StatesRecruiting
  • Clinical Site Partners, LLC dba Flourish ResearchWinter Park, United StatesRecruiting

And 134 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-523658-15-00
  • J3R-MC-YDAF
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)