Skip to content

Trial · Interventional

RecruitingPhase 3Registry data

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

Short name ENLIGHTEN-1

NCTNCT07321886 (opens ClinicalTrials.gov in a new tab)Other id27742Other idJ3R-MC-YDAGOther id2025-523657-34-00Other id2025
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 3
Enrollment
1,980 participants (estimated)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
15 countries

United States, Argentina, Australia, Belgium, Brazil, Canada, China, Germany, India, Japan, Poland, Puerto Rico, South Korea, Taiwan, United Kingdom

Start
6 Feb 2026
Primary completion
Mar 2028 (estimated)
Completion
Jul 2030 (estimated)
First posted
7 Jan 2026
Last update posted
22 Sept 2026
Conditions
Obesity · Overweight

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028202920302031
  1. Ph 3

    ENLIGHTEN-1

    NCT07321886

    6 Feb 2026 to est. Jul 2030

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • EloralintideDrug
  • PlaceboDrug

Arms5

  • Experimental

    Eloralintide Dose 1

    Participants will receive eloralintide subcutaneously (SC)

  • Experimental

    Eloralintide Dose 2

    Participants will receive eloralintide SC

  • Experimental

    Eloralintide Dose 3

    Participants will receive eloralintide SC

  • Experimental

    Eloralintide Dose 4

    Participants will receive eloralintide SC

  • Placebo comparator

    Placebo

    Participants will receive placebo SC

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent Change from Baseline in Body Weight

    Time frame · Baseline, Week 64

Secondary outcomes(18)

  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

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.