A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03322631
• Other study ID #: 16400
• Secondary ID: I8F-JE-GPGC
• Status: Completed
• Phase: Phase 1
• Start date: November 15, 2017
• Est. completion date: November 28, 2018

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 28, 2018
• Est. primary completion date: May 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Tirzepatide
Administered SC.
• Placebo
Administered SC.

Locations

Country	Name	City	State
Japan	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	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

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	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.	Baseline through Day 85
Secondary	Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Tirzepatide	Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of Tirzepatide in plasma.	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
Secondary	PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide	Area under the concentration versus time curve from time zero to tau (t) of Tirzepatide (AUC[0- t]), where tau is dosing interval of (0-168 hours).	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
Secondary	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	Baseline, Week 8