NCT05380323CompletedPhase 1
A Study of LY3541105 in Healthy and Overweight Participants
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
Source: ClinicalTrials.gov · Last updated 27 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 206 (actual)
- First submitted
- 1 May 2022
- Start date
- 10 May 2022
- Primary completion date
- 27 Aug 2024
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Obesity
- NCT number
- NCT05380323
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 206
- From 10 May 2022 to the primary completion date, 27 Aug 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Have history of diabetes (except gestational diabetes) or current diagnosis of diabetes
- Have history or current evidence of a clinically significant cardiovascular condition
Other
- Clinically significant abnormal electrocardiogram (ECG) at screening, as judged by the Investigator
Who the study is looking for
- 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
Age in the registry: 21 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| PRA International Coordinator of this site? Confirm its status | Lenexa | United States | Unknown status |
| ICON Early Phase Services Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.