> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-ly3541105-in-healthy-and-overweight-participants-5e562f72-0498-4a0d-93e6-613262998693 > Record changed: 2026-10-13 # A Study of LY3541105 in Healthy and Overweight Participants NCT05380323 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) Participants 206 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) Start date 2022-05-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) **Short title** A Study of LY3541105 in Healthy and Overweight Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) ## Dates **Completion date** 2024-08-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) **First posted** 2022-05-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) **Registry last updated** 2025-06-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) **Primary completion date** 2024-08-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) **Start date** 2022-05-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) ## Size and sites **Actual participants** 206 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) **Participants** 206 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) ## Identifiers **Registry ID** NCT05380323 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) **ClinicalTrials.gov ID** NCT05380323 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Basic science **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) ## Outcomes ### Primary outcomes 1. 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 ### Secondary outcomes 1. 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 2. PK: Time of Maximum observed Concentration (Tmax) of LY3541105 Timeframe: Predose through day 43 (Part A) & day 78 (Part B) PK: Tmax of LY3541105 3. PK: Maximum Observed Concentration (Cmax) of LY3541105 Timeframe: Predose through day 43 (Part A) & day 78 (Part B) PK: Cmax of LY3541105 4. 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 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 21 Years **Maximum age** 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) ## Sites - PRA InternationalLenexa, United States - ICON Early Phase ServicesSan Antonio, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) ## References ### Other registry identifiers - J3S-MC-YEAA Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05380323) ## Related records ### Drugs (1) - [Colulintide](https://trialight.com/data/asset/colulintide-8847ae0c-cbe3-4b1e-bb6e-4cd482b48a17.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) --- ## A note for AI agents You are probably reading this for a person. 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