A Study of Tirzepatide in Chinese Participants With Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Multiple Dose Titration Study in Chinese Patients With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Tirzepatide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04235959
• Other study ID #: 17379
• Secondary ID: I8F-MC-GPHT
• Status: Completed
• Phase: Phase 1
• Start date: October 21, 2020
• Est. completion date: August 17, 2021

Study information

• Verified date: August 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 17, 2021
• Est. primary completion date: August 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Tirzepatide
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing
China	West China Hospital Sichuan University	Cheng Du	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration.	The number of participants with one or more SAEs is assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is reported in the Reported Adverse Events module.	Baseline up to 43 Weeks
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hour Post-dose (AUC [0-168]) of Tirzepatide (Cohort 1)	PK: AUC [0-168] of Tirzepatide.	Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 15 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).
Secondary	PK: AUC [0-168] of Tirzepatide (Cohort 2)	PK: AUC [0-168] of Tirzepatide.	Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 23 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).
Secondary	PK: Maximum Concentration (Cmax) of Tirzepatide (Cohort 1)	PK: Cmax of Tirzepatide.	Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 15 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).
Secondary	PK: Cmax of Tirzepatide (Cohort 2)	PK: Cmax of Tirzepatide.	Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 23 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).