A Study of LY3541105 in Healthy and Overweight Participants

Phase 1

Active, not recruiting

• Conditions: Healthy; Overweight
• Interventions: Drug: Placebo; Drug: LY3541105

• Registration Number: NCT05380323
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-01
• Study Start: 2022-05-10
• Study First Submitted QC: 2022-05-17
• Study First Posted: 2022-05-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-19
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 205

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (Part C)	Placebo	Placebo administered SC.
Placebo (Part A)	Placebo	Placebo administered SC.
Placebo (Part B)	Placebo	Placebo administered SC.
LY3541105 (Part B)	LY3541105	Multiple ascending doses of LY3541105 administered SC.
LY3541105 (Part A)	LY3541105	Single ascending doses of LY3541105 administered subcutaneously (SC).
LY3541105 (Part C)	LY3541105	Escalating doses of LY3541105 administered SC.

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
PK: Time of Maximum observed Concentration (Tmax) of LY3541105	Predose through day 43 (Part A) & day 64 (Part B)	PK: Tmax of LY3541105
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3541105	Predose through day 43 (Part A) & day 64 (Part B)	PK: AUC of LY3541105
Pharmacodynamics (PD): Absolute and Percentage Change from Baseline in Body Weight	Predose through week 26 (Part B Only)	PD: Absolute and Percentage Change from Baseline in Body Weight
PK: Maximum Observed Concentration (Cmax) of LY3541105	Predose through day 43 (Part A) & day 64 (Part B)	PK: Cmax of LY3541105

Trial Locations

Locations (2)

ICON Early Phase Services; 🇺🇸 San Antonio, Texas, United States

PRA International; 🇺🇸 Lenexa, Kansas, United States