A Study of LY3457263 in Obese Participants

Phase 1

Completed

• Conditions: Overweight; Obesity
• Interventions: Drug: LY3457263; Drug: Tirzepatide; Drug: Placebo

• Registration Number: NCT05582096
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-13
• Study First Posted: 2022-10-17
• Study Start: 2022-11-11
• Primary Completion: 2023-06-08
• Study Completion: 2023-06-08
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + Tirzepatide	Placebo	Placebo administered SC in combination with tirzepatide given SC.
LY3457263 + Tirzepatide	LY3457263	LY3457263 administered subcutaneously (SC) in combination with tirzepatide given SC.
Placebo + Tirzepatide	Tirzepatide	Placebo administered SC in combination with tirzepatide given SC.
LY3457263 + Tirzepatide	Tirzepatide	LY3457263 administered subcutaneously (SC) in combination with tirzepatide given 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	Baseline up to 11 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
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3457263	Predose on Day 1 up to 43 days postdose	PK: AUC of LY3457263

Trial Locations

Locations (1)

LabCorp CRU, Inc.; 🇺🇸 Daytona Beach, Florida, United States