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NCT Number: NCT07060456

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Perking University Peoples' Hospital

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

Linong JI

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, able and willing to provide a written informed consent
  • Diagnosed with type 2 diabetes ≥ 90 days;
  • On stable once-daily dose of basal insulin alone or in combination with metformin and/or SGLT2 inhibitor ≥ 90 days;
  • HbA1c was 7.5%~11.0% (both inclusive);
  • Body Mass Index (BMI) ≥22 kg/m2 at screening.

Exclusion criteria

  • A history of type 1 diabetes, specific diabetes, or secondary diabetes;
  • Have a history of severe hypoglycemia within t180 days prior to screening;
  • History of acute cardiovascular and cerebrovascular diseases within 180 days prior to screening;
  • Have a history of malignancy within 5 years;
  • Known or suspected allergy or intolerance to the investigational medicinal products or related products;
  • Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 90 days;
  • Any conditions that the Investigator judges might not be suitable to participate in the trial.

Treatment and study plan

HRS9531

Drug

HRS9531-low dose

Placebo

Drug

Placebo

Primary outcomes

  1. Change in HbA1c

    Time frame: from baseline to Week 40

    Change in HbA1c after 40 weeks of treatment.

Secondary outcomes

  1. Proportion of subjects reaching HbA1<7.0%

    Time frame: from baseline to Week 40

    Proportion of subjects reaching HbA1<7.0% after 40 weeks of treatment.

  2. Proportion of subjects reaching HbA1≤6.5%

    Time frame: from baseline to Week 40

    Proportion of subjects reaching HbA1≤6.5% after 40 weeks of treatment.

  3. Change in FPG

    Time frame: from baseline to Week 40

    Change in FPG after 40 weeks of treatment.

  4. Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score

    Time frame: From baseline to Week 40

    Change from baseline in DTSQs after 40 weeks of treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 11, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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