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Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

NCTNCT04235959 (opens ClinicalTrials.gov in a new tab)Other id17379Other idI8F-MC-GPHT
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
24 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
1 country

China

Start
21 Oct 2020
Primary completion
17 Aug 2021
Completion
17 Aug 2021
First posted
22 Jan 2020
Last update posted
6 Jul 2023
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202020212022
  1. Ph 1

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

    NCT04235959

    21 Oct 2020 to 17 Aug 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TirzepatideDrug
  • PlaceboDrug

Arms2

  • Placebo comparator

    Placebo

    Participants received placebo once weekly (QW) subcutaneously (SC).

  • Experimental

    Tirzepatide - Cohort 1 (2.5 to 10 Milligram (mg)) and Cohort 2 (2.5 to 15 mg)

    Participants in Cohort 1 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, and 10 mg for Weeks 12 through 15. Participants in Cohort 2 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, and 10 mg for Weeks 12 through 15, 12.5 mg for Weeks 16 through 19, and 15 mg for Weeks 20 through 23.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration.

    Time frame · Baseline up to 43 Weeks

    Registry description

    The number of participants with one or more SAEs is assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is reported in the Reported Adverse Events module.

Secondary outcomes(4)

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hour Post-dose (AUC [0-168]) of Tirzepatide (Cohort 1)

    Time frame · Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 15 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).

    Registry description

    PK: AUC \[0-168\] of Tirzepatide.

  2. PK: AUC [0-168] of Tirzepatide (Cohort 2)

    Time frame · Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 23 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).

    Registry description

    PK: AUC \[0-168\] of Tirzepatide.

  3. PK: Maximum Concentration (Cmax) of Tirzepatide (Cohort 1)

    Time frame · Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 15 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).

    Registry description

    PK: Cmax of Tirzepatide.

  4. PK: Cmax of Tirzepatide (Cohort 2)

    Time frame · Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 23 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).

    Registry description

    PK: Cmax of Tirzepatide.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline up to 43 Weeks

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration.

GroupValue (participants)
Placebo1
Cohort 1 (2.5 to 10 Milligram (mg) Tirzepatide)0
Cohort 2 (2.5 to 15 mg Tirzepatide)0
Secondary and other outcome results(4)
Secondary outcomeGeometric mean· Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 15 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hour Post-dose (AUC [0-168]) of Tirzepatide (Cohort 1)

GroupValue (nanogram hour per milliliter (ng*h/mL))Spread
Cohort 1: 2.5 to 10 mg Tirzepatide3510014
Secondary outcomeGeometric mean· Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 23 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).

PK: AUC [0-168] of Tirzepatide (Cohort 2)

GroupValue (nanogram hour per milliliter (ng*h/mL))Spread
Cohort 2: 2.5 to 15 mg Tirzepatide3090014
Secondary outcomeGeometric mean· Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 15 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).

PK: Maximum Concentration (Cmax) of Tirzepatide (Cohort 1)

GroupValue (nanograms per milliliter (ng/mL))Spread
Cohort 1: 2.5 to 10 mg Tirzepatide30628
Secondary outcomeGeometric mean· Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 23 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).

PK: Cmax of Tirzepatide (Cohort 2)

GroupValue (nanograms per milliliter (ng/mL))Spread
Cohort 2: 2.5 to 15 mg Tirzepatide25717

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboParticipants received placebo QW SC.0 / 41 / 44 / 4
Cohort 1 (2.5 to 10 Milligram (mg) Tirzepatide)Participants in Cohort 1 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, and 10 mg for Weeks 12 through 15.0 / 100 / 1010 / 10
Cohort 2 (2.5 to 15 mg Tirzepatide)Participants in Cohort 2 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, 10 mg for Weeks 12 through 15, 12.5 mg for Weeks 16 through 19, and 15 mg for Weeks 20 through 23.0 / 100 / 1010 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2023

11 results

A Phase 1 Multiple Dose Study of Tirzepatide in Chinese Patients with Type 2 Diabetes.

Feng et al. 2023Advances in therapycited by 18

PMID 37285081PMC10329955DOI 10.1007/s12325-023-02536-8PUB-37285081

Free to read · publisher termsCC BY-NC11 results
Read at sourceSee results (11)

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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