DRUG
Eloralintide
Administered SC.
Status
Completed
Phase
Phase 2
Enrollment
263
Locations
43
Results
Posted
Publications
1
Study summary
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.
Interventions
DRUG
Administered SC.
DRUG
Administered SC.
Timeline
First posted
Jan 30, 2024
Study start
Feb 5, 2024
Primary completion
May 30, 2025
Study completion
Aug 14, 2025
Results posted
Jun 24, 2026
Registry updated
Jun 24, 2026
Outcomes
Percent Change From Baseline in Body Weight at Week 48
Time frame · Baseline, 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.
Change From Baseline in Body Weight at Week 48
Time frame · Baseline, 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.
Mean Percentage of Participants Who Achieved Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline to Week 48
Time frame · 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.
Mean Percentage of Participants Who Achieved ≥ 10% Body Weight Reduction From Baseline to Week 48
Time frame · 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.
Change From Baseline in Body Mass Index (BMI) at Week 48
Time frame · Baseline, 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.
Pharmacokinetics (PK): Area Under the Curve (AUC) of Eloralintide at Steady State
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 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).
PK: Maximum Concentration (Cmax) of Eloralintide at Steady State
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 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).
Eligibility
Inclusion Criteria: W8M-MC-LAA1 * Are males and females who agree to abide by the reproductive and contraceptive requirements W8M-MC-CWMM: * Have a body mass index (BMI) * ≥30 kilogram/square meter (kg/m²), or * ≥27 kg/m² and \<30 kg/m², or with at least 1 weight-related comorbidity * Have had a stable body weight for the 3 months prior to randomization (\<5%) body weight gain and/or loss. Exclusion Criteria: W8M-MC-LAA1 * Have any prior diagnosis of diabetes mellitus except gestational diabetes. * Have any of the following cardiovascular conditions within 6 months prior to screening: * acute myocardial infarction * cerebrovascular accident (stroke) * unstable angina, or * hospitalization due to congestive heart failure (CHF). * Have a history of acute or chronic pancreatitis. * Have an on-going or history of bradyarrhythmia and/or sinus bradycardia at screening and baseline. W8M-MC-CWMM * Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening. * Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma. * Have poorly controlled hypertension. * Have a history of symptomatic gallbladder disease within the past 2 years * Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease. * Have a lifetime history of suicide attempts.
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
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
Charter Research - Lady Lake
The Villages, Florida, United States
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, United States
Medical Research Partners
Ammon, Idaho, United States
Great Lakes Clinical Trials - Andersonville
Chicago, Illinois, United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, United States
NorthShore University Health System
Skokie, Illinois, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, United States
L-MARC Research Center
Louisville, Kentucky, United States
Knownwell
Needham, Massachusetts, United States
Lucida Clinical Trials
New Bedford, Massachusetts, United States
Headlands Research - Detroit
Southfield, Michigan, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States
StudyMetrix Research
City of Saint Peters, Missouri, United States
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