A Study of HS-20094 Versus Dulaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 Diabete

Clinical Trial5 Sept 2025Phase 3● 4/10i

A Study of HS-20094 Versus Dulaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 Diabete

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Phase 3 trial tests HS-20094, a once-weekly GLP-1 receptor agonist, versus dulaglutide in 546 adults with type 2 diabetes inadequately controlled on metformin alone or with SGLT2 inhibitors. Open-label comparison running 52 weeks with HbA1c reduction as primary endpoint, completion expected March 2027. Jiangsu Hansoh enters the competitive once-weekly GLP-1 space dominated by Novo Nordisk's Ozempic and Eli Lilly's Mounjaro, targeting the large metformin-failure population. Direct head-to-head with dulaglutide positions this Chinese biosimilar for potential market share in Asia-Pacific regions.

Strategic Signal

Hansoh's head-to-head design against dulaglutide signals preparation for biosimilar-level pricing rather than premium positioning against market leaders Ozempic and Mounjaro. The 52-week duration and metformin-failure population mirror registration strategies used by established GLP-1s, suggesting regulatory filing intent in China and potentially other Asian markets. This follows the SGLT2 inhibitor playbook where Chinese companies captured significant domestic market share through competitive pricing of clinically equivalent products.

GLP-1Type 2 diabetesDrug comparisonsJiangsu Hansoh Pharmaceutical

Original Abstract

The study is being conducted to evaluate the efficacy and safety of HS-20094 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Dulaglutide QW for 44 weeks and 52 weeks. | Condition(s): Type 2 Diabetes | Primary endpoint(s): Change in HbA1c | Enrollment: 546 (estimated) | Phase: Phase 3 | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. | Expected completion: 2027-03-30 | Status: Not Yet Recruiting | Last update: 2025-09-05

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