NCT06900075

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

Efficacy and Safety of Efsubaglutide Alfa Injection 3 Mg Every Two Weeks in Patients with Type 2 Diabetes: a Multicenter, Randomized, Open-Label Study

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Efsubaglutide Alfa 3mg Q2W and 1mg QW	Efsubaglutide Alfa 3 mg administered once every two weeks for 8 weeks, followed by a switch to Efsubaglutide Alfa 1 mg administered once weekly for an additional 8 weeks of treatment.
DRUG	Efsubaglutide Alfa 1mg QW and 3mg Q2W	Efsubaglutide Alfa 1 mg administered once weekly for 8 weeks, followed by a switch to Efsubaglutide Alfa 3 mg administered once every two weeks for an additional 8 weeks of treatment.

Timeline

• Start date: 2025-07-30
• Primary completion: 2026-01-30
• Completion: 2026-03-31
• First posted: 2025-03-28
• Last updated: 2025-03-28