A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes
Study Details
Study Description
Brief Summary
The purposes of this study are to determine:
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The safety of tirzepatide and any side effects that might be associated with it.
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How much tirzepatide gets into the bloodstream and how long it takes the body to remove it.
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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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Tirzepatide Tirzepatide administered subcutaneously (SC). |
Drug: Tirzepatide
Administered SC.
Other Names:
|
Placebo Comparator: Placebo Placebo administered SC. |
Drug: Placebo
Administered SC.
|
Outcome Measures
Primary Outcome Measures
- 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]
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Secondary Outcome Measures
- Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Tirzepatide [Baseline through Day 85]
PK: Cmax of tirzepatide
- PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide [Baseline through Day 85]
PK: AUC of tirzepatide
- Pharmacodynamics (PD): Change from Baseline to 8 Weeks in Fasting Plasma Glucose [Baseline, Week 8]
PD: Change from Baseline to 8 Weeks in Fasting Plasma Glucose
Eligibility Criteria
Criteria
Inclusion Criteria:
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Have T2DM controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (metformin or dipeptidyl peptidase [DPP]-IV inhibitors)
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Have a body mass index of 20.0 to 35.0 kilograms per square meter, inclusive
Exclusion Criteria:
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Have known allergies to tirzepatide, glucagon-like peptide (GLP)-1 analogs, or related compounds
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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
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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
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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. | Hachioji | Tokyo | Japan | 192-0071 |
2 | 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 | 169-0073 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16400
- I8F-JE-GPGC