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ENLIGHTEN-10NCT07900633

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

StatusNot Yet Recruiting
PhasePhase 3
Primary completion (estimated)
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Record History

All 2 versions: 2 with changes below.

  1. New version filed on ClinicalTrials.gov
  2. Study First Submitted

Endpoints

Primary

Percent Change from Baseline in Body Weight
Timeframe: Baseline, Week 64
Change from Baseline in Hemoglobin A1c (HbA1c)
Timeframe: Baseline, Week 36

Secondary (9)

Change from Baseline in Waist-to-Height Ratio
Change from Baseline in Systolic Blood Pressure
Percent Change from Baseline in High-Sensitivity C-reactive Protein (hsCRP)
Percent Change from Baseline in Triglycerides
Change from Baseline in Body Mass Index (BMI)
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Change from Baseline in Short Form-36 (SF-36 v2) Score
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
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

EloralintideExperimental

Participants will receive eloralintide subcutaneously (SC)

PlaceboPlacebo comparator

Participants will receive placebo SC

Drugs: Eloralintide, Placebo

Sites

309 sites in 21 countries

United States 70, Argentina 23, China 21, Italy 17, Brazil 15, Mexico 15, South Korea 15, Spain 14, France 12, Germany 12, Turkey (Türkiye) 12, Australia 11, Canada 11, Japan 10, Romania 10, Ukraine 10, Hungary 8, India 8, Czechia 6, Poland 6, Puerto Rico 3