Back to resultsA Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Tirzepatide
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- 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.
- 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.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tirzepatide
Placebo
Arm Description
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.
Participants received placebo administered into the SC tissue of the abdominal wall.
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
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
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Tirzepatide
Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of Tirzepatide in plasma.
PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide
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).
Pharmacodynamics (PD): Change From Baseline to 8 Weeks in Fasting Plasma Glucose
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03322631
Brief Title
A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes
Official Title
A Multiple-Ascending Dose Study in Japanese Patients With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3298176
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
May 29, 2018 (Actual)
Study Completion Date
November 28, 2018 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tirzepatide
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo administered into the SC tissue of the abdominal wall.
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
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.
Time Frame
Baseline through Day 85
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Tirzepatide
Description
Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of Tirzepatide in plasma.
Time Frame
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
Title
PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide
Description
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).
Time Frame
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
Title
Pharmacodynamics (PD): Change From Baseline to 8 Weeks in Fasting Plasma Glucose
Description
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
Time Frame
Baseline, Week 8
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 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
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
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.
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0071
Country
Japan
Facility Name
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.
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
169-0073
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes
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