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NCT Number: NCT07282600

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

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asociación de Beneficencia Hospital Sirio Libanés, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

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:
  • 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

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. Percent Change from Baseline in Total Body Fat Mass

    Time frame: Baseline, Week 64

  2. Change from Baseline in Waist Circumference

    Time frame: Baseline, Week 64

  3. Change from Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, Week 64

  4. Percent Change in Baseline in Triglycerides

    Time frame: Baseline, Week 64

  5. Change from Baseline in Systolic Blood Pressure

    Time frame: Baseline, Week 64

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

    Time frame: Baseline, Week 64

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

    Time frame: Baseline, Week 64

  8. Percent Change from Baseline in Fasting Insulin

    Time frame: Baseline, Week 64

  9. Change in Medication Use

    Time frame: Baseline through Week 64

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

    Time frame: Baseline, Week 64

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

    Time frame: Baseline, Week 64

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

    Time frame: Baseline, Week 64

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

    Time frame: Baseline, Week 64

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

    Time frame: Baseline, Week 64

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

    Time frame: Baseline through Week 64

  16. 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 Obesity or Overweight, and Type 2 Diabetes

Acronym: ENLIGHTEN-2

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 15, 2025
Registry last updated
Jul 17, 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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