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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,980
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
Percent Change from Baseline in Triglycerides
Time frame: Baseline, Week 64
Change from Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 64
Time to Onset of Type 2 Diabetes (T2D)
Time to Onset of Type 2 Diabetes (T2D) in Participants with Prediabetes at Randomization
Time frame: Baseline to Week 168 and Week 191
Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 64
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 64
Percent Change from Baseline in Fasting Insulin
Time frame: Baseline, Week 64
Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Time frame: Baseline, Week 64
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Trial question 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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MFA Clinical Research
Tuscaloosa, Alabama, United States
Headlands Research - Scottsdale
Scottsdale, Arizona, United States
Neighborhood Healthcare Institute of Health
Escondido, California, United States
Ark Clinical Research - Fountain Valley
Fountain Valley, California, United States
Desert Oasis Healthcare Medical Group
Palm Springs, California, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
Care Access - Sacramento
Sacramento, California, United States
Southern California Clinical Research
Santa Ana, California, United States
University Clinical Investigators, Inc.
Tustin, California, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
...and 163 more locations
Time frame: Baseline, Week 64
Change from Baseline in Short Form-36 Version 2 (SF-36 v2) Score
Time frame: Baseline, Week 64
Change from Baseline in EQ-5D-5L
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 Improvement of Status (PGIS) Physical Function Weight
Time frame: Baseline, Week 64
Change in Medication Use
Time frame: Baseline through Week 64
Percent Change from Baseline in Body Weight in Participants with Prediabetes at Randomization
Time frame: Baseline, Week 168
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