Completed

Tirzepatide Safety and Efficacy in Chinese Type 2 Diabetes Patients

Study Aim

This phase 1 study aims to evaluate the safety of Tirzepatide in Chinese patients with Type 2 Diabetes, by assessing the number of participants who experience serious adverse events potentially related to the study drug.

What is being tested

Tirzepatide

+ Placebo

Drug

Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 20 to 70 Years

+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Placebo-ControlledPhase 1

Interventional

Study Start: October 2020

See protocol details

Summary

Principal SponsorEli Lilly and Company

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: October 21, 2020

Actual date on which the first participant was enrolled.

This study focuses on understanding the safety and side effects of a drug called tirzepatide in Chinese individuals with type 2 diabetes. The research aims to contribute to the basic science around this medication, particularly in terms of how it interacts with this specific patient population. The importance of this study lies in its potential to provide valuable insights into the use of tirzepatide, which could ultimately improve treatment options for those living with type 2 diabetes. During the study, participants will be monitored for a period of about six to eight months. The primary goal is to track any serious adverse events that the investigator considers related to the administration of tirzepatide. These events could include outcomes like hospitalization, significant disability, or any other condition deemed significant by the investigator. The study also measures how the body processes tirzepatide, including how much of it enters the bloodstream and how quickly the body eliminates it.

Official TitleA Multiple Dose Titration Study in Chinese Patients With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Tirzepatide

NCT04235959

Principal SponsorEli Lilly and Company

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

2 inclusion criteria required to participate

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

5 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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.

Group II

Placebo

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

West China Hospital Sichuan University

Chengdu, ChinaOpen West China Hospital Sichuan University in Google Maps

Suspended

Peking University First Hospital

Beijing, China

Completed2 Study Centers