A Study of LY3541105 in Healthy and Overweight Participants

Healthy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05380323
• Other study ID #: 18350
• Secondary ID: J3S-MC-YEAA
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 10, 2022
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 205
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Overweight

Intervention

Drug:
• LY3541105
Administered SC.
• Placebo
Administered SC.

Locations

Country	Name	City	State
United States	PRA International	Lenexa	Kansas
United States	ICON Early Phase Services	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3541105	PK: AUC of LY3541105	Predose through day 43 (Part A) & day 64 (Part B)
Secondary	PK: Time of Maximum observed Concentration (Tmax) of LY3541105	PK: Tmax of LY3541105	Predose through day 43 (Part A) & day 64 (Part B)
Secondary	PK: Maximum Observed Concentration (Cmax) of LY3541105	PK: Cmax of LY3541105	Predose through day 43 (Part A) & day 64 (Part B)
Secondary	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)