A Study of Tirzepatide in Chinese Participants With Type 2 Diabetes Mellitus
Study Details
Study Description
Brief Summary
The main purpose of this study is to learn more about the safety and side effects of tirzepatide in Chinese participants with type 2 diabetes mellitus. The study will also measure how much tirzepatide gets into the bloodstream and how long it takes the body to remove it. The study will last about six or eight months for each participant.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
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 up to Day 141 or Day 197]
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): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide [Predose on Day 1 up to Day 141 or Day 197]
PK: AUC of Tirzepatide
- PK: Maximum Concentration (Cmax) of Tirzepatide [Predose on Day 1 up to Day 141 or Day 197]
PK: Cmax of Tirzepatide
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have type 2 diabetes mellitus (T2DM) controlled with diet and exercise alone or are stable on a single oral antihyperglycemic medication (OAM), metformin, acarbose, or sulphonylureas only (other types of OAM [dipeptidyl peptidase IV inhibitors, sodium-glucose cotransporter-2 inhibitors, and thiazolidinediones] are not allowed in this study), for at least 3 months
-
Have a body mass greater than or equal to (≥)23 kilograms per square meter (kg/m²), inclusive
Exclusion Criteria:
-
Have type 1 diabetes mellitus
-
Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to Visit 1
-
Have a history of heart block or PR interval greater than (>)220 milliseconds (msec) or any abnormality in the 12-lead electrocardiogram (ECG) 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 a GI disease that impacts gastric emptying or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors
-
Have known allergies to tirzepatide, GLP-1 analogs, or related compounds or any components of the formulation
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | West China Hospital Sichuan University | Cheng Du | Sichuan | China | 610041 |
2 | Peking University First Hospital | Beijing | China | 100034 |
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.- 17379
- I8F-MC-GPHT