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

NCT07599410 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

  • T2DM

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

Sponsors & Collaborators

  • Fujian Shengdi Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-05-31
Completion
2027-07-31

Countries

  • China

Study Locations

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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 NCT07599410 on ClinicalTrials.gov