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NCT Number: NCT07321886

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

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.

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

CARDIAMET Investigaciones Médicas, 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 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

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 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

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. Percent Change from Baseline in Triglycerides

    Time frame: Baseline, Week 64

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

    Time frame: Baseline, Week 64

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

    Time frame: 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)

    Time frame: Baseline, Week 64

  7. Change from Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, Week 64

  8. Percent Change from Baseline in Fasting Insulin

    Time frame: Baseline, Week 64

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

    Time frame: Baseline, 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 Version 2 (SF-36 v2) Score

    Time frame: Baseline, Week 64

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

    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 Improvement of Status (PGIS) Physical Function Weight

    Time frame: Baseline, Week 64

  15. Change in Medication Use

    Time frame: Baseline through Week 64

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

    Time frame: Baseline, Week 168

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

    Time frame: Baseline through Week 64

  18. 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 question or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

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, Without Type 2 Diabetes

Acronym: ENLIGHTEN-1

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Jan 7, 2026
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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