The purpose of this study is to evaluate how well eloralintide and eloralintide with tirzepatide is tolerated and what side effects may occur in participants with overweight or obesity. The study drug will be administered subcutaneously (SC) (under the skin). Blood tests will be performed to check how much eloralintide and eloralintide with tirzepatide get into the bloodstream and how long it takes the body to eliminate it. There will be 6 cohorts. The study will last up to approximately 26 weeks, excluding screening for Cohorts A and B, 11 weeks for Cohorts C and D, and 12 weeks for Cohorts E and F.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
188
Administered SC
Administered SC
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Fortrea Clinical Research Unit
Daytona Beach, Florida, United States
Fortrea Clinical Research Unit
Dallas, Texas, United States
Cohorts A and B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Eloralintide and Tirzepatide
PK: AUC of Eloralintide and Tirzepatide
Time frame: Day 106 Predose to Approximately Week 26
Cohorts A and B: PK: Maximum Concentration (Cmax) of Eloralintide and Tirzepatide
PK: Cmax of Eloralintide and Tirzepatide
Time frame: Day 106 Predose to Approximately Week 26
Cohorts C and D: PK: AUC of Eloralintide and Tirzepatide
PK: AUC of Eloralintide and Tirzepatide
Time frame: Baseline Up to Approximately Week 11
Cohorts C and D: PK: Cmax of Eloralintide and Tirzepatide
PK: Cmax of Eloralintide and Tirzepatide
Time frame: Baseline Up to Approximately Week 11
Cohorts E and F: PK: AUC of Eloralintide
PK: AUC of Eloralintide
Time frame: Day 8 Predose Up to Approximately Week 12
Cohorts E and F: PK: Cmax of Eloralintide
PK: Cmax of Eloralintide
Time frame: Day 8 Predose Up to Approximately Week 12
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 and SAEs regardless of causality, will be reported in the Reported Adverse Events module
Time frame: Baseline Up to Approximately Week 26
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.