The purposes of this study are to determine: * The safety of tirzepatide and any side effects that might be associated with it. * How much tirzepatide gets into the bloodstream and how long it takes the body to remove it. * How tirzepatide affects the levels of blood sugar. This study includes eight weekly doses of tirzepatide or placebo given as subcutaneous (SC) injections just under the skin. The study will last about 16 weeks (total), including screening and follow-up. This study is for research purposes only and is not intended to treat any medical conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
48
Administered SC.
Administered SC.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Hachiōji, Tokyo, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Shinjuku-Ku, Tokyo, Japan
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Safety was assessed from time of consent through end of study (up to 85 days). Data presented are the number of participants who experienced 1 or more SAEs considered by the investigator to be related to study drug. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.
Time frame: Baseline through Day 85
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Tirzepatide
Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of Tirzepatide in plasma.
Time frame: Predose, 8, 24, 48, 72 and 168 hours post dose for Day 1 administration, and Predose, 8, 24, 48, and 168 hours post dose for Day 50 administration
PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide
Area under the concentration versus time curve from time zero to tau (τ) of Tirzepatide (AUC\[0- τ\]), where tau is dosing interval of (0-168 hours).
Time frame: Predose, 8, 24, 48, 72 and 168 hours post dose for Day 1 administration, and Predose, 8, 24, 48, and 168 hours post dose for Day 50 administration
Pharmacodynamics (PD): Change From Baseline to 8 Weeks in Fasting Plasma Glucose
Change from baseline to 8 weeks in Fasting Plasma Glucose was measured to investigate the PD effect of Tirzepatide after multiple SC doses administered to Japanese patients with T2DM
Time frame: Baseline, Week 8
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