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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT07060456

Run by

Fujian Shengdi Pharmaceutical Co., Ltd.

People needed

300

Starts

2025-07-25

Expected to finish

2027-03-01

Last updated by the study team

2026-01-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Perking University Peoples' Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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