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
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- 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
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
LY3457263 + Tirzepatide
LY3457263 administered subcutaneously (SC) in combination with tirzepatide given SC.
Intervention: LY3457263 (Drug)
LY3457263 + Tirzepatide
LY3457263 administered subcutaneously (SC) in combination with tirzepatide given SC.
Intervention: Tirzepatide (Drug)
Placebo + Tirzepatide
Placebo administered SC in combination with tirzepatide given SC.
Intervention: Tirzepatide (Drug)
Placebo + Tirzepatide
Placebo administered SC in combination with tirzepatide given SC.
Intervention: Placebo (Drug)
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
Time Frame: 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 Outcomes
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3457263(Predose on Day 1 up to 43 days postdose)