HSK7653 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

Phase 3 Completed 476 enrolled Sichuan Haisco Pharmaceutical Group Co., Ltd

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to assess the efficacy of HSK7653 (as monotherapy) compared with placebo after 24 weeks, and the safety (up to 52 weeks) of HSK7653 in Chinese patients with Type 2 diabetes who are insufficient glycaemic control with diet and exercise.

Timeline

Start: 2020-09-29
Primary completion: 2022-01-10
Completion: 2022-08-08

Outcome

Met primary endpoint

paper the least-squares (LS) mean difference (95% confidence interval [CI]) in HbA1c versus placebo was -0.63% (-0.81, -0.46) PMID 39434431 ↗

paper with cofrogliptin 10 mg and -0.59% (-0.77, -0.42) with cofrogliptin 25 mg (both p < 0.0001). PMID 39434431 ↗

Publications

Gao L, Bian F, Pan T, Jiang H, Feng B, Jiang C, Sun J, Xiao J, Yan P, Ji L. Efficacy and safety of cofrogliptin once every 2 weeks in Chinese patients with type 2 diabetes: A randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Obes Metab. 2025 Jan;27(1):280-290. doi: 10.1111/dom.16014. Epub 2024 Oct 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cofrogliptin	Small molecule	10 mg	Oral
Subject	Cofrogliptin	Small molecule	25 mg	Oral