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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,035
Administered SC
Administered SC
Percent Change from Baseline in Body Weight
Time frame: Baseline, Week 64
Percent Change from Baseline in Total Body Fat Mass
Time frame: Baseline, Week 64
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 64
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 64
Percent Change in Baseline in Triglycerides
Time frame: Baseline, Week 64
Change from Baseline in Systolic Blood Pressure
Time frame: Baseline, Week 64
Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 64
Percent Change from Baseline in High Sensitivity C-Reactive Protein (hsCRP)
Time frame: Baseline, Week 64
Percent Change from Baseline in Fasting Insulin
Time frame: Baseline, Week 64
Change in Medication Use
Time frame: Baseline through Week 64
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline, Week 64
Change from Baseline in Short Form-36 (SF-36 v2) Score
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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Time frame: Baseline, Week 64
Change from Baseline in EQ-5D-5L Score
Time frame: Baseline, Week 64
Change from Baseline in Control of Eating Questionnaire (CoEQ) Score
Time frame: Baseline, Week 64
Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) Physical Function Weight
Time frame: Baseline, Week 64
Pharmacokinetics (PK): Maximum Concentration at Steady State (Cmax,ss)
Time frame: Baseline through Week 64
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