Tirzepatide monotherapy in Chinese patients with early type 2 diabetes: A randomized, double-blind, placebo-controlled phase 3 trial (SURPASS-CN-MONO).

BACKGROUND: We report findings from the Chinese SURPASS-CN-MONO trial (ClinicalTrials.gov: NCT05963022) of tirzepatide monotherapy. METHODS: A multicenter, randomized, double-blind, phase 3 trial conducted at 29 centers in China. Adults with type 2 diabetes who had not received antihyperglycemic medication in the previous 90 days were randomized 1:1:1:1 to receive once-weekly 5, 10, or 15 mg tirzepatide or placebo. The primary endpoint was the mean change from baseline in hemoglobin A1c (HbA1c) at week 40. FINDINGS: In total, 206 patients received 5 (n = 52), 10 (n = 51), or 15 (n = 52) mg tirzepatide or placebo (n = 51). Under the efficacy estimand, the least-squares mean reductions in HbA1c from baseline to week 40 were significantly greater with 5, 10, and 15 mg tirzepatide than with placebo (-2.17%, -2.06%, and -2.15% vs. -0.13%, with treatment differences vs. placebo of -2.04% [95% confidence interval (CI): -2.46, -1.63], -1.93% [95% CI: -2.35, -1.51], and -2.02% [95% CI: -2.44, -1.60], respectively; p < 0.001 for all comparisons). The least-squares mean reductions in body weight from baseline to week 40 were significantly greater with 5, 10, and 15 mg tirzepatide vs. placebo (-6.0, -6.1, and -9.7 vs. -1.0 kg, respectively; p < 0.001 for all comparisons). In the tirzepatide groups, the most common treatment-emergent adverse events were gastrointestinal related; there was no clinically significant (<54 mg/dL) or severe hypoglycemia. CONCLUSION: Tirzepatide effectively reduced hyperglycemia and body weight with no increased risk of hypoglycemia in Chinese patients with early type 2 diabetes. The safety profile was consistent with previous trials of tirzepatide. FUNDING: This work was funded by Eli Lilly and Company.