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

NCT06900075 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-03-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06900075 on ClinicalTrials.gov