A Study of LY3457263 in Obese Participants

Phase 1CompletedNCT05582096

Eli Lilly and Company38 enrolled

Overview

The main purpose of this study is to evaluate the safety and tolerability of LY3457263 when administered in combination with tirzepatitide in overweight or obese participants. The study will also evaluate how much of LY3457263 gets into the blood stream and how long it takes the body to remove it in overweight or obese participants. The study will last up to approximately 11 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Overweight Obesity

Interventions

LY3457263DRUG

Administered SC.

TirzepatideDRUG

Administered SC.

PlaceboDRUG

Administered SC.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Participants who are overtly healthy as determined by medical evaluation * Have a stable body weight and body mass index (BMI) within the range 27.0 to 45.0 kilograms per meter squared (kg/m²) * Male or female participants not of childbearing potential Exclusion Criteria: * Have a mean sitting systolic blood pressure (BP) higher than 160 millimeters of mercury (mmHg) or a mean sitting diastolic BP higher than 90 mmHg from 3 measurements * Have an abnormal 12-lead electrocardiogram (ECG) at screening * Have type 1 or type 2 diabetes mellitus

Locations (1)

LabCorp CRU, Inc.

Daytona Beach, Florida, 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: Baseline up to 11 weeks

Secondary Outcomes

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3457263

PK: AUC of LY3457263

Time frame: Predose on Day 1 up to 43 days postdose

Data from ClinicalTrials.gov

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