NCT06849843

A Study of 3mg Once Every Two Weeks Administration of Efsubaglutide Alfa Injection in Type 2 Diabetes Patients.

A Multicenter, Randomized, Controlled Clinical Study of 3mg Once Every Two Weeks Administration of Efsubaglutide Alfa Injection in Type 2 Diabetes Patients With Poor Glycemic Control After Diet and Exercise Intervention.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a study to evaluate the impact and efficacy of Efsubaglutide Alfa injection 3mg QoW on the treatment of type 2 diabetes patients with poor glycemic control after dietary and exercise intervention. Primary objective: To evaluate the effect and role of continuous treatment with 3mg of Efsubaglutide Alfa QoW and 1mg of Efsubaglutide Alfa QW for 12 weeks on HbA1c in T2DM patients with poor glycemic control after dietary and exercise intervention. Secondary objectives: 1. To evaluate the effect of continuous treatment with 3mg of Efsubaglutide Alfa QoW for 12 weeks on glucose variability (change in time in range (TIR) relative to baseline) in T2DM patients with poor glycemic control after dietary and exercise intervention. 2. To evaluate the effect of continuous treatment with 3mg of Efsubaglutide Alfa QoW for 12 weeks on drug exposure (relative to 1mg QW) in T2DM patients with poor glycemic control after dietary and exercise intervention. 3. To evaluate the effect of continuous treatment with 3mg of Efsubaglutide Alfa QoW for 12 weeks on fasting plasma glucose (FPG) in T2DM patients with poor glycemic control after dietary and exercise intervention.

Conditions

• Type2 Diabetes

Interventions

Type	Name	Description
DRUG	Efsubaglutide Alfa Injection	Efsubaglutide Alfa 3mg/0.5ml
DRUG	Efsubaglutide Alfa Injection	Efsubaglutide Alfa 1mg/0.5ml

Timeline

• Start date: 2024-12-18
• Primary completion: 2025-05-29
• Completion: 2025-05-29
• First posted: 2025-02-27
• Last updated: 2025-09-12

Locations

10 sites across 1 country: China