Obesity, Overweight
Conditions
Brief summary
The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to evaluate the effects of LY3549492 in adults with obesity or overweight. Participation in the study will last about one year.
Interventions
DRUGLY3549492
Administered orally
DRUGPlacebo
Administered orally
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-GN01: * Assigned male at birth * Assigned female at birth, who are of non-childbearing potential W8M-MC-CWMM: * Have a BMI of * ≥ 30 kilograms per square meter (kg/m²) or * ≥ 27 kg/m² and \< 30 kg/m² with at least one 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-GN01: * Have Type 2 Diabetes Mellitus or Type 1 Diabetes Mellitus * Have a history of acute or chronic pancreatitis * Have renal impairment * Individuals who are of childbearing potential 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 signs and symptoms of any liver disease other than nonalcoholic fatty liver disease. * Have any of the following cardiovascular conditions within 3 months prior to screening: * acute myocardial infarction * cerebrovascular accident (stroke) * unstable angina, or * hospitalization due to congestive heart failure. * Have a history of symptomatic gallbladder disease within the past 2 years * Have a lifetime history of suicide attempts.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 36 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Body Weight (kilograms) | Baseline, Week 36 |
| Percentage of Participants who Achieve ≥5% Body Weight Reduction | Baseline, Week 36 |
| Percentage of Participants who Achieve ≥10% Body Weight Reduction | Baseline, Week 36 |
| Change from Baseline in Body Mass Index (BMI) | Baseline, Week 36 |
| Pharmacokinetics (PK): Average Concentration of LY3549492 | Week 36 |
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
Outcome results
None listed