A Study of LY3541105 in Healthy and Overweight Participants

Eli Lilly and Company206 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

206

Conditions

Overweight Healthy

Interventions

LY3541105DRUG

Administered SC.

PlaceboDRUG

Administered SC.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

PRA International

Lenexa, Kansas, United States

ICON Early Phase Services

San Antonio, Texas, United States

Outcomes

Primary Outcomes

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

Time frame: Predose up to 26 weeks

Secondary Outcomes

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3541105

PK: AUC of LY3541105

Time frame: Predose through day 43 (Part A) & day 78 (Part B)

PK: Time of Maximum observed Concentration (Tmax) of LY3541105

PK: Tmax of LY3541105

Time frame: Predose through day 43 (Part A) & day 78 (Part B)

PK: Maximum Observed Concentration (Cmax) of LY3541105

PK: Cmax of LY3541105

Time frame: Predose through day 43 (Part A) & day 78 (Part B)

Pharmacodynamics (PD): Absolute and Percentage Change from Baseline in Body Weight

PD: Absolute and Percentage Change from Baseline in Body Weight

Time frame: Predose through week 26 (Part B Only)

Data from ClinicalTrials.gov

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