NCT04235959

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2020

Typical duration for phase_1 diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

October 21, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2021

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

July 6, 2023

Completed
Last Updated

July 6, 2023

Status Verified

August 1, 2022

Enrollment Period

10 months

First QC Date

January 20, 2020

Results QC Date

August 11, 2022

Last Update Submit

August 11, 2022

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

    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.

    Baseline up to 43 Weeks

Secondary Outcomes (4)

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

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

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

    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: Cmax of Tirzepatide (Cohort 2)

    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).

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

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

EXPERIMENTAL

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.

Drug: Tirzepatide

Interventions

TirzepatideDRUG

Administered SC

Also known as: LY3298176
Tirzepatide - Cohort 1 (2.5 to 10 Milligram (mg)) and Cohort 2 (2.5 to 15 mg)
PlaceboDRUG

Administered SC

Placebo

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

West China Hospital Sichuan University

Chengdu, Sichuan, 610041, China

Location

Peking University First Hospital

Beijing, 100034, China

Location

Related Publications (1)

  • Feng P, Sheng X, Ji Y, Urva S, Wang F, Miller S, Qian C, An Z, Cui Y. A Phase 1 Multiple Dose Study of Tirzepatide in Chinese Patients with Type 2 Diabetes. Adv Ther. 2023 Aug;40(8):3434-3445. doi: 10.1007/s12325-023-02536-8. Epub 2023 Jun 7.

    PMID: 37285081DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide ReceptorsReceptors, G-Protein-CoupledReceptors, Cell SurfaceMembrane ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, Gastrointestinal HormoneReceptors, Peptide

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • 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 DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2020

First Posted

January 22, 2020

Study Start

October 21, 2020

Primary Completion

August 17, 2021

Study Completion

August 17, 2021

Last Updated

July 6, 2023

Results First Posted

July 6, 2023

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)