The purpose of this study is to measure side effects of LY3971297 injection administered under the skin in healthy participants and obese participants with high blood pressure (BP). Blood tests will be performed to check how much LY3971297 gets into the bloodstream and how long it takes the body to eliminate it. This is a 7-part study. The study duration will be approximately 60 days for Parts A and F, and approximately 90 days for Parts B, C, D, E, and G.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
225
CenExel ACT
Anaheim, California, United States
RECRUITINGICON Early Phase Services
San Antonio, Texas, United States
RECRUITINGHakata Clinic
Fukuoka, Japan
Part A and F: 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
Part A and F: A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
Time frame: Baseline (Day of Exposure) to Day 29 post-dose
Part B, C, D, E, & G: 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
Part B, C, D, E, \& G: A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
Time frame: Baseline (Day of Exposure) to Day 57 post-dose
Part F: Pharmacokinetics (PK): Area Under the Concentration curve (AUC) of LY3971297
Part F: PK: AUC of LY3971297
Time frame: Baseline Up to Day 29 post-dose for Part F
Part F: PK: Maximum Observed Drug Concentration (Cmax) of LY3971297
Part F: PK: Cmax of LY3971297
Time frame: Baseline Up to Day 29 post-dose for Part F
Part B, C, D, E, and G: Pharmacokinetics (PK): Area Under the Concentration curve (AUC) of LY3971297
Part B, C, D, E, and G: PK: AUC of LY3971297
Time frame: Predose on day 1 up to 29 days post-dose for Part A and pre-dose on day 1 up to 57 days post-dose for Part B, C, D, E, and G
Part B, C, D, E, and G: PK: Maximum Observed Drug Concentration (Cmax) of LY3971297
Part B, C, D, E, and G: PK: Cmax of LY3971297
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
P-One Clinic
Hachiōji, Japan
RECRUITINGClinical Research Hospital Tokyo
Shinjuku-ku, Japan
RECRUITINGLilly Centre for Clinical Pharmacology
Singapore, Singapore
RECRUITINGTime frame: Predose on day 1 up to 29 days post-dose for Part A and pre-dose on day 1 up to 57 days post-dose for Part B, C, D, E, and G