Back to resultsA Study of LY3457263 in Obese Participants
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3457263
Tirzepatide
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Overweight
Eligibility Criteria
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
Sites / Locations
- LabCorp CRU, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LY3457263 + Tirzepatide
Placebo + Tirzepatide
Arm Description
LY3457263 administered subcutaneously (SC) in combination with tirzepatide given SC.
Placebo administered SC in combination with tirzepatide given SC.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3457263
PK: AUC of LY3457263
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05582096
Brief Title
A Study of LY3457263 in Obese Participants
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
June 8, 2023 (Actual)
Study Completion Date
June 8, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY3457263 + Tirzepatide
Arm Type
Experimental
Arm Description
LY3457263 administered subcutaneously (SC) in combination with tirzepatide given SC.
Arm Title
Placebo + Tirzepatide
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC in combination with tirzepatide given SC.
Intervention Type
Drug
Intervention Name(s)
LY3457263
Intervention Description
Administered SC.
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Administered SC.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC.
Primary Outcome Measure Information:
Title
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
Description
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 Outcome Measure Information:
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3457263
Description
PK: AUC of LY3457263
Time Frame
Predose on Day 1 up to 43 days postdose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
LabCorp CRU, Inc.
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of LY3457263 in Obese Participants
We'll reach out to this number within 24 hrs