Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07060456
PHASE3

Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin

Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The study is being conducted to evaluate the efficacy and safety of HRS9531 compared with placebo in participants with type 2 diabetes mellitus not adequately controlled with basal insulin, with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study may include up to 23 visits.

Official title: A Phase III, Multicenter, Randomized, Double Blinded, Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 Versus Placebo in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-07-25

Completion Date

2027-03

Last Updated

2026-01-02

Healthy Volunteers

No

Conditions

Interventions

DRUG

HRS9531

HRS9531-low dose

DRUG

HRS9531

HRS9531-high dose

DRUG

Placebo

Placebo

Locations (1)

Perking University Peoples' Hospital

Beijing, Beijing Municipality, China