The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to investigate weight management efficacy and safety with LY3841136 compared with placebo in adult participants with obesity or overweight. The study will last about 64 weeks and may include up to 17 visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
263
Administered SC.
Administered SC.
Percent Change From Baseline in Body Weight at Week 48
Least squares (LS) means were calculated using a mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Treatment + Time + Sex + Baseline BMI Category + Baseline + Time\*Sex +Time\*Baseline BMI Category + Treatment\*Time + Time\*Baseline. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Time frame: Baseline, Week 48
Change From Baseline in Body Weight at Week 48
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment + Time + Sex + Baseline BMI Category + Baseline + Time\*Sex +Time\*Baseline BMI Category + Treatment\*Time + Time\*Baseline. Variance-Covariance structure (Change from Baseline) = Unstructured.
Time frame: Baseline, Week 48
Mean Percentage of Participants Who Achieved Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline to Week 48
Mean percentage of participants who achieved ≥5% body weight reduction was analysed by logistic regression model with multiple imputation. Model: Variable = Baseline + Treatment + Sex + Baseline BMI Category. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 48 in imputed data sets using Rubin's rule.
Time frame: Baseline to Week 48
Mean Percentage of Participants Who Achieved ≥ 10% Body Weight Reduction From Baseline to Week 48
Mean percentage of participants who achieved ≥10% body weight reduction was analysed by logistic regression model with multiple imputation. Model: Variable = Baseline + Treatment + Sex + Baseline BMI Category. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 48 in imputed data sets using Rubin's rule.
Time frame: Baseline to Week 48
Change From Baseline in Body Mass Index (BMI) at Week 48
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The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Chandler, Arizona, United States
Headlands Research - Scottsdale
Scottsdale, Arizona, United States
The Institute for Liver Health II dba Arizona Liver Health-Tucson
Tucson, Arizona, United States
NorCal Medical Research, Inc
Greenbrae, California, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Northeast Research Institute (NERI)
Fleming Island, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Charter Research - Winter Park
Orlando, Florida, United States
...and 33 more locations
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment + Time + Sex + Baseline BMI Category + Baseline + Time\*Sex +Time\*Baseline BMI Category + Treatment\*Time + Time\*Baseline. Variance-Covariance structure (Change from Baseline) = Unstructured.
Time frame: Baseline, Week 48
Pharmacokinetics (PK): Area Under the Curve (AUC) of Eloralintide at Steady State
PK samples were analyzed using a population PK model approach to estimate AUC at steady state. Data presented are Geometric Mean with 90% prediction interval (PI).
Time frame: Predose at Week 0, Week 4, Week 8, Week 12, Week 24, Week 36; Post dose (2 to 6 hours after dosing) at Week 0, Week 24; Post dose (24 to 72 hours after dosing) at Week 12; random at Week 48
PK: Maximum Concentration (Cmax) of Eloralintide at Steady State
PK samples were analyzed using a population PK model approach to estimate Cmax at steady state. Data presented are Geometric Mean with 90% prediction interval (PI).
Time frame: Predose at Week 0, Week 4, Week 8, Week 12, Week 24, Week 36; Post dose (2 to 6 hours after dosing) at Week 0, Week 24; Post dose (24 to 72 hours after dosing) at Week 12; random at Week 48