Obesity
Conditions
Brief summary
The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in participants with obesity. Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it following weekly or monthly administration. Part A of the study will last approximately 16 weeks, excluding screening period. Part B of the study will last approximately 20 weeks, excluding the screening period. Part C of the study will last approximately 8 weeks, excluding the screening period.
Interventions
DRUGLY3532226
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Have a body weight not exceeding 150 kilograms (kg) or 330 pounds (lb) and body mass index (BMI) within the range of 30 to 40 kilogram per square meter (kg/m²) * Have had a stable body weight that is less than or equal to 5% change in body weight for 3 months prior to screening and enrollment
Exclusion criteria
* Have a lifetime history of a suicide attempt * Have a history or presence of psychiatric disorders, including a history of major depressive disorder within the last 2 years * Have a baseline Patient Health Questionnaire-9 (PHQ-9) score of 15 or greater, and/or a score of 2 or greater for either of the first 2 questions on the PHQ-9 questionnaire * Have a known clinically significant gastric emptying abnormality, have undergone gastric bypass surgery or restrictive bariatric surgery * Have taken approved or investigational medication for weight loss, within the previous 3 months or 5 half-lives of study screening, whichever is earlier * Intend to use any weight-loss medications during study participation * Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline to Study Completion (Up to 16 Weeks) | A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module |
| Part B: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline to Study Completion (Up to 20 Weeks) | A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module |
| Part C: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline to Study Completion (Up to 8 Weeks)] | A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3532226 | Predose on Day 1 through Week 16 | PK: Cmax of LY3532226 |
| Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226 | Predose on Day 1 through Week 16 | PK: AUC of LY3532226 |
| Part B: PK: Cmax of LY3532226 | Predose on Day 1 through Week 20 | PK: Cmax of LY3532226 |
| Part B: PK: AUC of LY3532226 | Predose on Day 1 through Week 20 | PK: AUC of LY3532226 |
| Part C: Pharmacodynamic (PD): Change in insulin sensitivity index (Si) | Baseline up to Approximately Week 4 | Part C: PD: Change in Si |
Countries
Singapore, 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