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ENLIGHTEN-6NCT07392190

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

StatusRecruiting
PhasePhase 3
Primary completion (estimated)
Track this trial

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Record History

All 19 versions: 19 with changes below. See every version on ClinicalTrials.gov ↗

  1. Study sites revised (185)
  2. Study sites: 187 to 185
    • Eligibility criteria shortened, about 1 word
  3. Site details revised at 4 of 187 sitesv17
  4. Study sites: 188 to 187v16
  5. Trial sites expanded: 173 → 188 locationsv15
  6. Trial sites reduced: 185 → 173 locationsv14
  7. Study sites: 183 to 185v13
  8. Trial sites expanded: 180 → 183 locationsv12
  9. Study sites: 178 to 180v11
  10. Study sites revised (178)v10
  11. Site details revised at 7 of 178 sitesv9
  12. Site details revised at 21 of 178 sitesv8
  13. Site details revised at 11 of 178 sitesv7
  14. Site details revised at 4 of 178 sitesv6
  15. Site details revised at 14 of 178 sitesv5
  16. Study Status, Referencesv4
  17. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2026 to Feb 10, 2026
    • Site details revised at 178 of 178 sites
    v3
  18. Study sites: 179 to 178v2
  19. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Percent Change from Baseline in Body Weight
Timeframe: Baseline, Week 64

Secondary (15)

Change from Baseline in Waist Circumference
Percent Change in Baseline in Triglycerides
Change from Baseline in Systolic Blood Pressure
Change from Baseline in Body Mass Index (BMI)
Change from Baseline in Fasting Glucose in Participants with Type 2 Diabetes at Baseline
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Change from Baseline in Short Form-36 (SF-36 v2) Score
Change from Baseline in EQ-5D-5L Score
Change from Baseline in Control of Eating Questionnaire (CoEQ) Score
Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) Physical Function Weight
Percent Change from Baseline in Fasting Insulin
Percent Change from Baseline in High Sensitivity C-Reactive Protein (hsCRP)
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Change in Medication Use
Pharmacokinetics (PK): Maximum Concentration at Steady State (Cmax,ss)
PK: Area Under the Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-ᴛ)ss)

Arms and interventions

Eloralintide Dose 1Experimental

Participants will receive eloralintide subcutaneously (SC)

Eloralintide Dose 2Experimental

Participants will receive eloralintide SC

Eloralintide Dose 3Experimental

Participants will receive eloralintide SC

Eloralintide Dose 4Experimental

Participants will receive eloralintide SC

PlaceboPlacebo comparator

Participants will receive placebo SC

Drugs: Eloralintide, Placebo

Sites

185 sites in 14 countries

United States 58, China 22, Israel 17, Japan 11, Australia 10, India 10, Romania 10, Spain 10, Belgium 9, Taiwan 9, Brazil 7, Mexico 7, Czechia 3, Puerto Rico 2