A Study of LY3457263 in Obese Participants

Obesity Clinical Trial

Official title:

A Dose-Escalation Treatment, Phase 1, Investigator- and Participant-Blind, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of LY3457263 in Combination With Tirzepatide in Overweight or Obese Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05582096
• Other study ID #: 18463
• Secondary ID: J1R-MC-GZFC
• Status: Completed
• Phase: Phase 1
• Start date: November 11, 2022
• Est. completion date: June 8, 2023

Study information

• Verified date: July 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 8, 2023
• Est. primary completion date: June 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• LY3457263
Administered SC.
• Tirzepatide
Administered SC.
• Placebo
Administered SC.

Locations

Country	Name	City	State
United States	LabCorp CRU, Inc.	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline up to 11 weeks
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3457263	PK: AUC of LY3457263	Predose on Day 1 up to 43 days postdose