Trial results for Tirzepatide in Chinese participants with type 2 diabetes were posted on ClinicalTrials.gov on 2025-08-08. The Phase 3 study demonstrated that tirzepatide 10 mg reduced mean HbA1c by -26.1 mmol/mol and mean body weight by -4.8 kg compared to placebo.
Background
The study investigated tirzepatide for the treatment of type 2 diabetes. This trial specifically focused on Chinese participants with type 2 diabetes, addressing conditions such as diabetes mellitus, glucose metabolism disorders, metabolic disease, and endocrine system diseases.
Trial design
The study (NCT05691712) was a Phase 3, completed trial that enrolled 257 Chinese participants with type 2 diabetes. The main purpose was to compare the effect of adding tirzepatide or placebo to titrated basal insulin on glycemic control. Interventions included various doses of tirzepatide (5 mg, 10 mg, 15 mg) and placebo.
Key results
The trial results showed dose-dependent improvements in glycemic control and body weight reduction.
For the outcome "Mean Change From Baseline in HbA1c" (measured in millimoles per mole):
- Participants receiving tirzepatide 10 mg experienced a least squares mean change of -26.1 (Standard Error: 1.367).
- Participants receiving tirzepatide 15 mg experienced a least squares mean change of -25.9 (Standard Error: 1.386).
- Participants receiving tirzepatide 5 mg experienced a least squares mean change of -23.0 (Standard Error: 1.329).
- Participants receiving placebo experienced a least squares mean change of -9.96 (Standard Error: 1.340).
For the outcome "Mean Change From Baseline in Body Weight" (measured in kilograms):
- Participants receiving tirzepatide 5 mg experienced a least squares mean change of -2.7 (Standard Error: 0.52).
- Participants receiving tirzepatide 10 mg experienced a least squares mean change of -4.8 (Standard Error: 0.54).
- Participants receiving tirzepatide 15 mg experienced a least squares mean change of -4.3 (Standard Error: 0.55).
- Participants receiving placebo experienced a least squares mean change of 1.7 (Standard Error: 0.53).
Regarding the percentage of participants achieving HbA1c targets:
- 75.81% of participants on tirzepatide 5 mg achieved HbA1c <7.0% and ≤6.5%.
- 78.95% of participants on tirzepatide 10 mg achieved HbA1c <7.0% and ≤6.5%.
- 78.18% of participants on tirzepatide 15 mg achieved HbA1c <7.0% and ≤6.5%.
Key analyses comparing tirzepatide to placebo showed statistically significant differences (p-value 0.001 for all listed comparisons):
- The least squares mean difference for HbA1c was -16.1 mmol/mol (95.0% CI: -19.9 to -12.36) for tirzepatide 10 mg.
- The least squares mean difference for HbA1c was -15.9 mmol/mol (95.0% CI: -19.7 to -12.1) for tirzepatide 15 mg.
- The least squares mean difference for HbA1c was -13.06 mmol/mol (95.0% CI: -16.8 to -9.34) for tirzepatide 5 mg.
- The least squares mean difference for body weight was -4.4 kg (95.0% CI: -5.8 to -2.9) for tirzepatide 5 mg.
- The least squares mean difference for body weight was -6.5 kg (95.0% CI: -8.0 to -5.0) for tirzepatide 10 mg.
- The least squares mean difference for body weight was -6.0 kg (95.0% CI: -7.5 to -4.5) for tirzepatide 15 mg.
What this means
The results indicate that tirzepatide, when added to titrated basal insulin, significantly improves glycemic control and reduces body weight in Chinese participants with type 2 diabetes. The dose-dependent reductions in HbA1c and body weight, along with a high percentage of participants achieving target HbA1c levels, suggest that tirzepatide could be an effective treatment option for this population. These findings support its potential role in managing type 2 diabetes.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05691712, titled "A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes," were posted on 2025-08-08 on clinicaltrials.gov.