A Study of LY3985863 in Healthy Participants

Eli Lilly and Company24 enrolled

Overview

The purpose of this study is to evaluate how well LY3985863 is tolerated and what side effects may occur in healthy Chinese participants. The study drug will be administered subcutaneously (SC) (under the skin). Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

LY3985863DRUG

Administered SC

PlaceboDRUG

Administered SC

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Are native Chinese participants * Are overtly healthy * Have body weight of at least 50.0 kilogram (kg) for male or 45.0 kg for female and a body mass index of 20.0 to 30.0 kilogram per square meter (kg/m²), inclusive * Have a stable body weight within 3 months Exclusion Criteria: * Have known allergies to any components of the LY3985863 formulation * Have concomitant disease known to influence skeletal muscle protein * Have current or a history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs, of constituting a risk when taking the study medication or completing study procedures, or of interfering with the interpretation of the data * Have a 12-lead echocardiogram (ECG) abnormality * Have used within 3 months or intend to use medications during the study that promote weight loss

Locations (1)

Peking University Third Hospital

Beijing, China

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 and SAEs regardless of causality, will be reported in the Reported Adverse Events module

Time frame: Baseline to Study Completion (Up to 19 Weeks)

Secondary Outcomes

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3985863

PK: Cmax of LY3985863

Time frame: Predose on Day 1 up to Approximately Week 8 Post Dose

PK: Area Under the Concentration Versus Time Curve (AUC) of LY3985863

PK: AUC of LY3985863

Time frame: Predose on Day 1 up to Approximately Week 8 Post Dose

Data from ClinicalTrials.gov

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