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

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes
• Interventions: Drug: HRS953; Drug: Placebo

• Registration Number: NCT07060456
• Lead Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-06-22
• Study Start: 2025-07-01
• Study First Submitted QC: 2025-07-01
• Last Update Submitted: 2025-07-01
• Study First Posted: 2025-07-11
• Last Update Posted: 2025-07-11
• Primary Completion: 2027-02
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A: HRS953-low dose	HRS953	-
Treatment group B: HRS953-high dose	HRS953	-
Treatment group C	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	from baseline to Week 40	Change in HbA1c after 40 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects reaching HbA1<7.0%	from baseline to Week 40	Proportion of subjects reaching HbA1\<7.0% after 40 weeks of treatment.
Proportion of subjects reaching HbA1≤6.5%	from baseline to Week 40	Proportion of subjects reaching HbA1≤6.5% after 40 weeks of treatment.
Change in FPG	from baseline to Week 40	Change in FPG after 40 weeks of treatment.
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score	From baseline to Week 40	Change from baseline in DTSQs after 40 weeks of treatment.

Trial Locations

Locations (1)

Perking University Peoples' Hospital; 🇨🇳 Beijing, Beijing, China