Health TrialsbyHealthPanel

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

ConditionT2DM
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFujian Shengdi Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, aged 18 to 70 years on the day of signing the informed consent form;

Have a documented history of type 2 diabetes mellitus for at least 6 months at screening, diagnosed according to the criteria in Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2024 Edition);

HbA1c between 7.5% and 10.5% at screening;

Have received lifestyle intervention alone for at least 8 weeks, or stable metformin monotherapy for at least 8 weeks prior to screening. Stable treatment is defined as no change in daily drug dosage, with no planned modifications to the regimen during the entire trial period;

Disqualifiers

Participants with relevant abnormal test results at screening.

Participants with clinically significant abnormal findings on electrocardiogram (ECG) that, in the investigator's opinion, may compromise subject safety.

Participants with poorly controlled blood pressure.

Participants diagnosed with or suspected of having type 1 diabetes, specific types of diabetes, or secondary diabetes.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS9531 Tablet

    Drug

    HRS9531 Tablet dose 1

  • HRS9531 Tablet

    Drug

    HRS9531 Tablet dose 2

  • HRS9531 Tablet

    Drug

    HRS9531 Tablet dose 3

  • HRS9531 Tablet

    Drug

    HRS9531 Tablet dose 4

  • HRS9531 Tablet

    Drug

    HRS9531 Tablet dose 5

  • HRS9531 Tablet placebo

    Drug

    HRS9531 Tablet placebo

Treatment groups

240 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Treatment group A: HRS9531 TabletExperimental treatment 1 intervention
Group B: Treatment group B: HRS9531 TabletExperimental treatment 1 intervention
Group C: Treatment group C: HRS9531 TabletExperimental treatment 1 intervention
Group D: Treatment group D: HRS9531 TabletExperimental treatment 1 intervention
Group E: Treatment group E: HRS9531 TabletExperimental treatment 1 intervention
Group F: Treatment group F:PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in glycated hemoglobin (HbA1c) relative to baseline

Time frame
Week 20.

Secondary outcomes

1

Percentage of participants achieving HbA1c < 7.0%

Time frame
Week 20
2

Percentage change in fasting body weight relative to baseline

Time frame
Week 20
3

Change in fasting plasma glucose (FPG) relative to baseline

Time frame
Week 20
4

Incidence of hypoglycemic events across all groups

Time frame
Week 20

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Shengdi Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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