A Phase 3, Multi-center, Open-label, Randomized Study to Evaluate the Efficacy and Safety of JY09 Versus Dulaglutide in Patients With T2DM Inadequately Controlled by Metformin

ClinicalTrials17 Sept 2025·Phase 3● 3/10i

A Phase 3, Multi-center, Open-label, Randomized Study to Evaluate the Efficacy and Safety of JY09 Versus Dulaglutide in Patients With T2DM Inadequately Controlled by Metformin

Beijing Dongfang Biotech Co., Ltd.

Phase 3 open-label trial comparing two doses of JY09 versus dulaglutide as add-on therapy to metformin in adults with type 2 diabetes. Enrolled 600 participants with HbA1c as primary endpoint, expected completion October 2026. Beijing Dongfang Biotech is testing a GLP-1 candidate in a crowded T2D market dominated by established players like Novo Nordisk (semaglutide) and Eli Lilly (tirzepatide). This represents another Chinese biotech attempting to challenge Western incumbents in the lucrative diabetes space.

Strategic signal

Beijing Dongfang faces formidable market access barriers in Western markets where dulaglutide now competes against superior agents like tirzepatide and oral semaglutide. Chinese biotechs typically pursue domestic-first strategies given regulatory pathways and cost advantages in local markets. JY09 would need compelling differentiation beyond dulaglutide equivalence to gain traction outside China, particularly as payers increasingly demand evidence against best-in-class comparators rather than older GLP-1s.

GLP-1Type 2 diabetesDrug comparisonsBeijing Dongfang Biotech Co., Ltd.

Original Abstract

The aim of the study is to compare the efficacy and safety of two JY09 doses versus dulaglutide as add-on therapy to metformin in participants with type 2 diabetes mellitus (T2DM) | Condition(s): Type2 Diabetes Mellitus | Primary endpoint(s): HbA1c | Enrollment: 600 (actual) | Phase: Phase 3 | Sponsor: Beijing Dongfang Biotech Co., Ltd. | Expected completion: 2026-10-01 | Status: Active Not Recruiting | Last update: 2025-09-17

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