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NOT YET RECRUITING
NCT07599410
PHASE2

A Research Study to Investigate the Efficacy and Safety of HRS9531 Tablets in Participants With Type 2 Diabetes Mellitus

Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The aim of the trial is to investigate the efficacy and safety of HRS9531 tablets versus placebo in participants with type 2 diabetes mellitus who failed to achieve adequate glycemic control on lifestyle intervention alone or on a stable dose of metformin. This study will last 20 weeks.

Official title: A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group Phase 2 Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Participants With Type 2 Diabetes Mellitus.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2026-07

Completion Date

2027-07

Last Updated

2026-05-20

Healthy Volunteers

No

Conditions

Interventions

DRUG

HRS9531 Tablet

HRS9531 Tablet dose 1

DRUG

HRS9531 Tablet

HRS9531 Tablet dose 2

DRUG

HRS9531 Tablet

HRS9531 Tablet dose 3

DRUG

HRS9531 Tablet

HRS9531 Tablet dose 4

DRUG

HRS9531 Tablet

HRS9531 Tablet dose 5

DRUG

HRS9531 Tablet placebo

HRS9531 Tablet placebo

Locations (2)

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Qilu Hospital of Shandong University

Jinan, Shandong, China