Back to resultsA Study of Tirzepatide in Chinese Participants With Type 2 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Tirzepatide
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 2
Eligibility 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
Sites / Locations
- West China Hospital Sichuan University
- Peking University First Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Tirzepatide - Cohort 1 (2.5 to 10 Milligram (mg)) and Cohort 2 (2.5 to 15 mg)
Arm Description
Participants received placebo once weekly (QW) subcutaneously (SC).
Participants in Cohort 1 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, and 10 mg for Weeks 12 through 15. Participants in Cohort 2 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, and 10 mg for Weeks 12 through 15, 12.5 mg for Weeks 16 through 19, and 15 mg for Weeks 20 through 23.
Outcomes
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.
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.
Secondary Outcome Measures
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.
PK: AUC [0-168] of Tirzepatide (Cohort 2)
PK: AUC [0-168] of Tirzepatide.
PK: Maximum Concentration (Cmax) of Tirzepatide (Cohort 1)
PK: Cmax of Tirzepatide.
PK: Cmax of Tirzepatide (Cohort 2)
PK: Cmax of Tirzepatide.
Full Information
NCT ID
NCT04235959
First Posted
January 20, 2020
Last Updated
August 11, 2022
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT04235959
Brief Title
A Study of Tirzepatide in Chinese Participants With Type 2 Diabetes Mellitus
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 21, 2020 (Actual)
Primary Completion Date
August 17, 2021 (Actual)
Study Completion Date
August 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo once weekly (QW) subcutaneously (SC).
Arm Title
Tirzepatide - Cohort 1 (2.5 to 10 Milligram (mg)) and Cohort 2 (2.5 to 15 mg)
Arm Type
Experimental
Arm Description
Participants in Cohort 1 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, and 10 mg for Weeks 12 through 15.
Participants in Cohort 2 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, and 10 mg for Weeks 12 through 15, 12.5 mg for Weeks 16 through 19, and 15 mg for Weeks 20 through 23.
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration.
Description
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.
Time Frame
Baseline up to 43 Weeks
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hour Post-dose (AUC [0-168]) of Tirzepatide (Cohort 1)
Description
PK: AUC [0-168] of Tirzepatide.
Time Frame
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).
Title
PK: AUC [0-168] of Tirzepatide (Cohort 2)
Description
PK: AUC [0-168] of Tirzepatide.
Time Frame
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).
Title
PK: Maximum Concentration (Cmax) of Tirzepatide (Cohort 1)
Description
PK: Cmax of Tirzepatide.
Time Frame
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).
Title
PK: Cmax of Tirzepatide (Cohort 2)
Description
PK: Cmax of Tirzepatide.
Time Frame
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
West China Hospital Sichuan University
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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A Study of Tirzepatide in Chinese Participants With Type 2 Diabetes Mellitus
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