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NCT Number: NCT07392190

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

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Emeritus Research, Botany, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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
  • 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

Treatment and study plan

Eloralintide

Drug

Administered SC

Other names: LY3841136

Placebo

Drug

Administered SC

Primary outcomes

  1. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 64

Secondary outcomes

  1. Change from Baseline in Waist Circumference

    Time frame: Baseline, Week 64

  2. Percent Change in Baseline in Triglycerides

    Time frame: Baseline, Week 64

  3. Change from Baseline in Systolic Blood Pressure

    Time frame: Baseline, Week 64

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

    Time frame: Baseline, Week 64

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

    Time frame: Baseline, Week 64

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

    Time frame: Baseline, Week 64

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

    Time frame: Baseline, Week 64

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

    Time frame: Baseline, Week 64

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

    Time frame: Baseline, Week 64

  10. Percent Change from Baseline in Fasting Insulin

    Time frame: Baseline, Week 64

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

    Time frame: Baseline, Week 64

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

    Time frame: Baseline, Week 64

  13. Change in Medication Use

    Time frame: Baseline through Week 64

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

    Time frame: Baseline through Week 64

  15. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Acronym: ENLIGHTEN-6

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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