RecruitingPhase 3NCT07060456

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

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.

Sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Enrollment

300 participants

Start Date

Jul 25, 2025

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria7

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.