Recruiting

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.

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ClinicalTrials.gov IDNCT07060456
PhasePHASE3
Enrollment300
SponsorFujian Shengdi Pharmaceutical Co., Ltd.
Age18 Years and older
SexALL
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Conditions studied

Type 2 Diabetes

About this study

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.

Interventions

Primary outcomes

Eligibility information

Inclusion Criteria: 1. Male or female, able and willing to provide a written informed consent 2. Diagnosed with type 2 diabetes ≥ 90 days; 3. On stable once-daily dose of basal insulin alone or in combination with metformin and/or SGLT2 inhibitor ≥ 90 days; 4. HbA1c was 7.5%\~11.0% (both inclusive); 5. Body Mass Index (BMI) ≥22 kg/m2 at screening. Exclusion Criteria: 1. A history of type 1 diabetes, specific diabetes, or secondary diabetes; 2. Have a history of severe hypoglycemia within t180 days prior to screening; 3. History of acute cardiovascular and cerebrovascular diseases within 180 days prior to screening; 4. Have a history of malignancy within 5 years; 5. Known or suspected allergy or intolerance to the investigational medicinal products or related products; 6. Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 90 days; 7. Any conditions that the Investigator judges might not be suitable to participate in the trial.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-30.