A Study of LY3457263 in Obese Participants
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
2 other identifiers
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2022
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2022
CompletedFirst Posted
Study publicly available on registry
October 17, 2022
CompletedStudy Start
First participant enrolled
November 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 8, 2023
CompletedJuly 18, 2023
July 1, 2023
7 months
October 13, 2022
July 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3457263
Predose on Day 1 up to 43 days postdose
Study Arms (2)
LY3457263 + Tirzepatide
EXPERIMENTALLY3457263 administered subcutaneously (SC) in combination with tirzepatide given SC.
Placebo + Tirzepatide
PLACEBO COMPARATORPlacebo administered SC in combination with tirzepatide given SC.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
LabCorp CRU, Inc.
Daytona Beach, Florida, 32117, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2022
First Posted
October 17, 2022
Study Start
November 11, 2022
Primary Completion
June 8, 2023
Study Completion
June 8, 2023
Last Updated
July 18, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share