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ACTIVE NOT RECRUITING
NCT06649344
PHASE3

A Study of HRS9531 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 Diabetes

Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The study is being conducted to evaluate the efficacy and safety of HRS9531 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Semaglutide QW for 36 weeks and 52 weeks.

Official title: A Phase III,Multicenter,Randomized,Open-label,Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 With Semaglutide in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Metformin Monotherapy or in Combination With SGLT2 Inhibitors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

884

Start Date

2024-10-31

Completion Date

2026-09-30

Last Updated

2025-06-12

Healthy Volunteers

No

Conditions

Interventions

DRUG

HRS9531 Injection

HRS9531 injected subcutaneously once weekly.

DRUG

Semaglutide Injection

Semaglutide injected subcutaneously once weekly.

Locations (1)

Zhu Xianyi Memorial Hospital,Tianjin Medical University

Tianjin, Tianjin Municipality, China