drugset / Trial / NCT06257966

A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Dulaglutide in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin

NCT06257966

Phase 3 Active not recruiting 600 enrolled Beijing Dongfang Biotech Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

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)

Timeline

Start
2024-07-17
Primary completion
2026-10-01
Completion
2026-11-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dulaglutide Peptide 1.5 mg Subcutaneous
Subject JY09 Protein / enzyme biologic 1.2 mg Subcutaneous
Subject JY09 Protein / enzyme biologic 2.4 mg Subcutaneous
Background Metformin Small molecule Oral