Healthy, Overweight
Conditions
Keywords
Obesity
Brief summary
The main purpose of this study is to evaluate the safety and tolerability of LY3541105 in healthy and overweight participants. Blood tests will be performed to check how much LY3541105 gets into the bloodstream and how long it takes the body to eliminate it. The study will also evaluate the effects of LY3541105 on body weight and assess safety and tolerability of LY3541105. This is a 3-part study and may last up to 15, 26 and 24 weeks for each participant and may include up to 7, 15 and 16 visits in parts A, B and C, respectively.
Interventions
DRUGLY3541105
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
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants who are overtly healthy as determined by medical evaluation * Male participants who agree to refrain from sperm donation and to use contraceptive methods and female participants not of childbearing potential * Have a body mass index (BMI) in the range of greater than or equal to (\>/=) 18.5 to less than (\<) 32 kilogram per square meter (kg/m²), both inclusive (in Part A) or a BMI in the range of \>/=27 to \<40 kg/m², both inclusive (in Part B and C) * Have had a stable weight for the last 3 months
Exclusion criteria
* Have history of diabetes (except gestational diabetes) or current diagnosis of diabetes * Clinically significant abnormal electrocardiogram (ECG) at screening, as judged by the Investigator * Have history or current evidence of a clinically significant cardiovascular condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Predose up to 26 weeks | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3541105 | Predose through day 43 (Part A) & day 78 (Part B) | PK: AUC of LY3541105 |
| PK: Time of Maximum observed Concentration (Tmax) of LY3541105 | Predose through day 43 (Part A) & day 78 (Part B) | PK: Tmax of LY3541105 |
| PK: Maximum Observed Concentration (Cmax) of LY3541105 | Predose through day 43 (Part A) & day 78 (Part B) | PK: Cmax of LY3541105 |
| Pharmacodynamics (PD): Absolute and Percentage Change from Baseline in Body Weight | Predose through week 26 (Part B Only) | PD: Absolute and Percentage Change from Baseline in Body Weight |
Countries
United States
Outcome results
None listed