A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes

Phase 1

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Have T2DM controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (metformin or dipeptidyl peptidase [DPP]-IV inhibitors)
Have a body mass index of 20.0 to 35.0 kilograms per square meter, inclusive

Exclusion Criteria

Have known allergies to tirzepatide, glucagon-like peptide (GLP)-1 analogs, or related compounds
Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before entry into the study or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
Have an abnormality in the 12-lead electrocardiogram at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
Have a history or presence of pancreatitis or gastrointestinal (GI) disorder or any GI disease which impacts gastric emptying or could be aggravated by GLP-1 analogs or DPP-IV inhibitors

Arm && Interventions

Group	Intervention	Description
Tirzepatide	Tirzepatide	Participants received escalating doses of 2.5 milligrams (mg), 5 mg, 10 mg and 15 mg of tirzepatide administered into the subcutaneous (SC) tissue of the abdominal wall.
Placebo	Placebo	Participants received placebo administered into the SC tissue of the abdominal wall.

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline through Day 85	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.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Tirzepatide	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	Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of Tirzepatide in plasma.
Pharmacodynamics (PD): Change From Baseline to 8 Weeks in Fasting Plasma Glucose	Baseline, Week 8	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
PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide	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	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).

Locations (1): 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.
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Shinjuku-Ku, Tokyo, Japan