Obesity, Overweight
Conditions
Brief summary
The main purpose of this study is to understand how safe and well-tolerated LY4174794 is in participants with obesity or overweight who are otherwise healthy. Blood tests will be performed to check how much LY4174794 gets into the bloodstream and how long it takes the body to eliminate it. Participation in this study will last about 30 to 39 weeks (7 to 10 months).
Interventions
DRUGLY4174794
Administered SC.
DRUGPlacebo
Administered SC.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy with no comorbidities related to body mass index (BMI), such as type 2 diabetes mellitus or unstable cardiovascular disease * Are overweight with a BMI of ≥27 kilogram per meter square (kg/m²), or have obesity with a BMI of ≥30 kg/ m² * Have had a self-reported stable weight for 3 months prior to screening
Exclusion criteria
* Have a history or presence of cardiovascular, respiratory, hepatic, renal, GI, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study intervention, or of interfering with the interpretation of data * Is an individual of childbearing potential (IOCBP)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A and 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 through end of the Follow-up (Week 25) | 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 TEAEs and SAEs Considered by the Investigator to be Related to Study Drug Administration | Baseline through end of the Follow-up (Week 33) | A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module. |
Secondary
| Measure | Time frame |
|---|---|
| Part A and C: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY4174794 | Predose on day 1 through end of the Follow-up Period (Week 25) |
| Part A and C: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4174794 | Predose on day 1 through end of the Follow-up Period (Week 25) |
| Part B: PK: Maximum Observed Drug Concentration (Cmax) of LY4174794 | Predose on day 1 through end of the Follow-up Period (Week 33) |
| Part B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4174794 | Predose on day 1 through end of the Follow-up Period (Week 33) |
Countries
Singapore, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed