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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Overweight
• Intervention / Treatment: Drug: Placebo; Drug: LY3541105

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • PRA International
  • Texas
    • San Antonio, Texas, United States, 78209
      • ICON Early Phase Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo (Part A); Placebo administered SC.	Drug: Placebo; Administered SC.
Placebo Comparator: Placebo (Part B); Placebo administered SC.	Drug: Placebo; Administered SC.
Placebo Comparator: Placebo (Part C); Placebo administered SC.	Drug: Placebo; Administered SC.
Experimental: LY3541105 (Part A); Single ascending doses of LY3541105 administered subcutaneously (SC).	Drug: LY3541105; Administered SC.
Experimental: LY3541105 (Part B); Multiple ascending doses of LY3541105 administered SC.	Drug: LY3541105; Administered SC.
Experimental: LY3541105 (Part C); Escalating doses of LY3541105 administered SC.	Drug: LY3541105; Administered SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Predose up to 26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacodynamics (PD): Absolute and Percentage Change from Baseline in Body Weight	PD: Absolute and Percentage Change from Baseline in Body Weight	Predose through week 26 (Part B Only)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3541105	PK: AUC of LY3541105	Predose through day 43 (Part A) & day 78 (Part B)
PK: Time of Maximum observed Concentration (Tmax) of LY3541105	PK: Tmax of LY3541105	Predose through day 43 (Part A) & day 78 (Part B)
PK: Maximum Observed Concentration (Cmax) of LY3541105	PK: Cmax of LY3541105	Predose through day 43 (Part A) & day 78 (Part B)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Actual): August 27, 2024
• Study Completion (Actual): August 27, 2024

Study Registration Dates

• First Submitted: May 1, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Obesity
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: 18350; J3S-MC-YEAA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No