A Study of Tirzepatide in Chinese Participants With Type 2 Diabetes Mellitus

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04235959
Collaborator
(none)
24
2
2
9.9
12
1.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Oct 21, 2020
Actual Primary Completion Date :
Aug 17, 2021
Actual Study Completion Date :
Aug 17, 2021

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 up to Day 141 or Day 197]

      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): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide [Predose on Day 1 up to Day 141 or Day 197]

      PK: AUC of Tirzepatide

    2. PK: Maximum Concentration (Cmax) of Tirzepatide [Predose on Day 1 up to Day 141 or Day 197]

      PK: Cmax of Tirzepatide

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 West China Hospital Sichuan University Cheng Du Sichuan China 610041
    2 Peking University First Hospital Beijing China 100034

    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:
    NCT04235959
    Other Study ID Numbers:
    • 17379
    • I8F-MC-GPHT
    First Posted:
    Jan 22, 2020
    Last Update Posted:
    Aug 24, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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 Aug 24, 2021