Phase 1
Completed N=24
A Study of Tirzepatide in Chinese Participants With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT04235959 ↗Enrolled (actual)
24
Serious AEs
4.2%
Results posted
Jul 2023
Primary outcomePrimary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration. — 1; 0; 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration. |
1; 0; 0 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hour Post-dose (AUC [0-168]) of Tirzepatide (Cohort 1) |
35100; 125000; 263000 | — |
| SECONDARY PK: AUC [0-168] of Tirzepatide (Cohort 2) |
30900; 110000; 357000 | — |
| SECONDARY PK: Maximum Concentration (Cmax) of Tirzepatide (Cohort 1) |
306; 1030; 2200 | — |
| SECONDARY PK: Cmax of Tirzepatide (Cohort 2) |
257; 915; 2930 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04235959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.