A Study of LY3541105 in Healthy and Overweight Participants
- 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.
- Short title
- A Study of LY3541105 in Healthy and Overweight Participants
- Official title
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2024-08-27
- First posted
- 2022-05-18
- Registry last updated
- 2025-06-27
- Primary completion date
- 2024-08-27
- Start date
- 2022-05-10
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Eli Lilly and Company
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05380323
- ClinicalTrials.gov ID
- NCT05380323
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Basic science
- Masking
- Double masking
- Masked roles
- Participants, Investigators
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
Timeframe: 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
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3541105
Timeframe: Predose through day 43 (Part A) & day 78 (Part B)
PK: AUC of LY3541105
PK: Time of Maximum observed Concentration (Tmax) of LY3541105
Timeframe: Predose through day 43 (Part A) & day 78 (Part B)
PK: Tmax of LY3541105
PK: Maximum Observed Concentration (Cmax) of LY3541105
Timeframe: 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
Timeframe: Predose through week 26 (Part B Only)
PD: Absolute and Percentage Change from Baseline in Body Weight
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 21 Years
- Maximum age
- 65 Years
- Healthy volunteers
- Yes
- 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
- 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
- PRA InternationalLenexa, United States
- ICON Early Phase ServicesSan Antonio, United States
Other registry identifiers
- J3S-MC-YEAA