Trial results for the SURPASS-CN-MONO study (NCT05963022) investigating tirzepatide monotherapy in Chinese participants with Type 2 Diabetes were posted on ClinicalTrials.gov on 2025-10-21. The study showed that 5 mg tirzepatide reduced Hemoglobin A1c (HbA1c) by -2.19 percentage points (Standard Error: 0.121) from baseline, compared to a reduction of -0.77 percentage points (Standard Error: 0.126) for placebo.
Background
The SURPASS-CN-MONO study, officially titled "A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-MONO)," aimed to investigate the efficacy and safety of tirzepatide as a monotherapy for individuals with Type 2 Diabetes in a Chinese population.
Trial design
The SURPASS-CN-MONO study (NCT05963022) was a Phase 3, randomized, placebo-controlled trial that enrolled 206 participants. The study investigated tirzepatide monotherapy in Chinese participants diagnosed with Type 2 Diabetes. Participants were randomly assigned to receive either 5 mg, 10 mg, or 15 mg tirzepatide, or a placebo. The study evaluated changes from baseline in Hemoglobin A1c (HbA1c) and Fasting Serum Glucose, as well as the percentage of participants achieving HbA1c target values of <7.0%.
Key results
The trial results demonstrated significant differences in glycemic control between the tirzepatide and placebo groups. For the outcome of "Change From Baseline in Hemoglobin A1c (HbA1c)":
- Participants receiving 5 mg tirzepatide achieved a least squares mean reduction of -2.19 percentage points (Standard Error: 0.121).
- Participants receiving 10 mg tirzepatide achieved a least squares mean reduction of -1.75 percentage points (Standard Error: 0.131).
- Participants receiving 15 mg tirzepatide achieved a least squares mean reduction of -2.03 percentage points (Standard Error: 0.124).
- Participants receiving placebo achieved a least squares mean reduction of -0.77 percentage points (Standard Error: 0.126).
Analyses using ANCOVA showed significant differences in HbA1c reduction compared to placebo: a least squares mean difference of -1.42 percentage points (95.0% CI: -1.76 to -1.07) with a p-value of 0.001 for 5 mg tirzepatide; a difference of -0.98 percentage points (95.0% CI: -1.34 to -0.63) with a p-value of 0.001 for 10 mg tirzepatide; and a difference of -1.26 percentage points (95.0% CI: -1.61 to -0.92) with a p-value of 0.001 for 15 mg tirzepatide.
Regarding the "Percentage of Participants With HbA1c Target Values of <7.0%":
- 90.38% of participants in the 5 mg tirzepatide group achieved this target.
- 86.36% of participants in the 10 mg tirzepatide group achieved this target.
- 83.33% of participants in the 15 mg tirzepatide group achieved this target.
- 38.30% of participants in the placebo group achieved this target.
Logistic regression analysis for achieving HbA1c <7.0% showed an Odds Ratio (OR) of 17.04 (95.0% CI: 5.62 to 51.73) with a p-value of 0.001 for 5 mg tirzepatide vs placebo; an OR of 7.51 (95.0% CI: 2.77 to 20.37) with a p-value of 0.001 for 10 mg tirzepatide vs placebo; and an OR of 7.24 (95.0% CI: 2.74 to 19.14) with a p-value of 0.001 for 15 mg tirzepatide vs placebo.
For the outcome of "Change From Baseline in Fasting Serum Glucose":
- Participants receiving 5 mg tirzepatide achieved a least squares mean reduction of -55.0 mg/dL (Standard Error: 3.00).
- Participants receiving 10 mg tirzepatide achieved a least squares mean reduction of -54.8 mg/dL (Standard Error: 3.16).
- Participants receiving 15 mg tirzepatide achieved a least squares mean reduction of -55.4 mg/dL (Standard Error: 3.06).
- Participants receiving placebo achieved a least squares mean reduction of -30.2 mg/dL (Standard Error: 3.07).
What this means
The results from the SURPASS-CN-MONO trial indicate that tirzepatide monotherapy significantly improved glycemic control in Chinese participants with Type 2 Diabetes across all tested doses (5 mg, 10 mg, and 15 mg) compared to placebo. The substantial reductions in HbA1c and Fasting Serum Glucose, coupled with a high percentage of participants achieving the HbA1c target of <7.0%, suggest that tirzepatide could be an effective treatment option for this population. These findings reinforce its potential role in managing Type 2 Diabetes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05963022, titled "A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-MONO)," were posted on 2025-10-21 on clinicaltrials.gov.