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

NCT ID: NCT03322631

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-15
• Study Completion Date: 2018-11-28

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Tirzepatide

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.

Group Type: EXPERIMENTAL

Tirzepatide

Intervention Type: DRUG

Administered SC.

Placebo

Participants received placebo administered into the SC tissue of the abdominal wall.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered SC.

Interventions

Tirzepatide

Administered SC.

Intervention Type: DRUG

Placebo

Administered SC.

Intervention Type: DRUG

Other Intervention Names

LY3298176

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

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.

Hachiōji, 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, Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

I8F-JE-GPGC

Identifier Type: OTHER

Identifier Source: secondary_id

16400

Identifier Type: -

Identifier Source: org_study_id