Obesity, Overweight
Conditions
Keywords
Overnutrition, Hormones, Chronic weight management
Brief 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
DRUGPlacebo
Administered SC.
DRUGEloralintide
Administered SC.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Body Weight at Week 48 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Body Weight at Week 48 | 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 | 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 | 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 | 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 | 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 | 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). |
Countries
United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 49.00 years STANDARD_DEVIATION 12.65 |
| Body Weight | 109.02 Kilograms (Kg) STANDARD_DEVIATION 21.96 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 222 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 205 Participants |
| Region of Enrollment United States | 28 Participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 28 | 0 / 24 | 0 / 28 | 0 / 54 | 0 / 24 | 0 / 52 |
| other Total, other adverse events | 25 / 53 | 15 / 28 | 12 / 24 | 27 / 28 | 40 / 54 | 20 / 24 | 34 / 52 |
| serious Total, serious adverse events | 3 / 53 | 3 / 28 | 1 / 24 | 1 / 28 | 3 / 54 | 2 / 24 | 1 / 52 |
Outcome results
None listed