A Phase 1, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and PK of LY3541105 Following Single Doses in Healthy/Overweight Participants and Multiple Doses in Overweight Participants
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Overweight
- Sponsor
- Eli Lilly and Company
- Enrollment
- 205
- Locations
- 2
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Placebo (Part C)
Placebo administered SC.
Intervention: Placebo
LY3541105 (Part A)
Single ascending doses of LY3541105 administered subcutaneously (SC).
Intervention: LY3541105
LY3541105 (Part B)
Multiple ascending doses of LY3541105 administered SC.
Intervention: LY3541105
LY3541105 (Part C)
Escalating doses of LY3541105 administered SC.
Intervention: LY3541105
Placebo (Part A)
Placebo administered SC.
Intervention: Placebo
Placebo (Part B)
Placebo administered SC.
Intervention: Placebo
Outcomes
Primary Outcomes
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
Time Frame: 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 Outcomes
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3541105(Predose through day 43 (Part A) & day 78 (Part B))
- PK: Time of Maximum observed Concentration (Tmax) of LY3541105(Predose through day 43 (Part A) & day 78 (Part B))
- PK: Maximum Observed Concentration (Cmax) of LY3541105(Predose through day 43 (Part A) & day 78 (Part B))
- Pharmacodynamics (PD): Absolute and Percentage Change from Baseline in Body Weight(Predose through week 26 (Part B Only))