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NOT YET RECRUITING
NCT06900075
PHASE3

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

Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2025-07-30

Completion Date

2026-03-31

Last Updated

2025-03-28

Healthy Volunteers

No

Conditions

Interventions

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.