drugset / Trial / NCT06900075

Efficacy and Safety of Efsubaglutide Alfa Injection 3 Mg Q2W in T2D Patients

NCT06900075

Phase 3 Not yet recruiting 88 enrolled Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
RandomizedCrossoverOpen-labelTreatment

Summary

This study is a multicenter, randomized, open-label, active-controlled clinical trial with a two-period crossover design, aimed at evaluating the efficacy and safety of Efsubaglutide Alfa Injection 3 mg administered Q2W in patients with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic control despite dietary and exercise interventions. The primary endpoint is time in range (TIR; glucose concentration 3·9-10·0 mmol/L) during the period from Week 6 to Week 8 of Efsubaglutide Alfa Injection treatment.

Timeline

Start
2025-07-30
Primary completion
2026-01-30
Completion
2026-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Efsubaglutide Alfa Protein / enzyme biologic 1 mg
Subject Efsubaglutide Alfa Protein / enzyme biologic 3 mg