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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT03322631
Collaborator
(none)
66
2
2
12.4
33
2.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Nov 15, 2017
Actual Primary Completion Date :
May 29, 2018
Actual Study Completion Date :
Nov 28, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tirzepatide

Tirzepatide administered subcutaneously (SC).

Drug: Tirzepatide
Administered SC.
Other Names:
  • LY3298176
  • Placebo Comparator: Placebo

    Placebo administered SC.

    Drug: Placebo
    Administered SC.

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Baseline through Day 85]

      A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

    Secondary Outcome Measures

    1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Tirzepatide [Baseline through Day 85]

      PK: Cmax of tirzepatide

    2. PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide [Baseline through Day 85]

      PK: AUC of tirzepatide

    3. Pharmacodynamics (PD): Change from Baseline to 8 Weeks in Fasting Plasma Glucose [Baseline, Week 8]

      PD: Change from Baseline to 8 Weeks in Fasting Plasma Glucose

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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 192-0071
    2 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 169-0073

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: 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), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03322631
    Other Study ID Numbers:
    • 16400
    • I8F-JE-GPGC
    First Posted:
    Oct 26, 2017
    Last Update Posted:
    Jan 24, 2019
    Last Verified:
    Jan 15, 2019
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 24, 2019