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.
ClinicalTrials.gov IDNCT07060456
PhasePHASE3
Enrollment300
SponsorFujian Shengdi Pharmaceutical Co., Ltd.
Age18 Years
SexALL
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
- Drug: HRS9531 — HRS9531-low dose
- Drug: HRS9531 — HRS9531-high dose
- Drug: Placebo — Placebo
Primary outcomes
- Change in HbA1c (from baseline to Week 40)
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
- Perking University Peoples' Hospital, Beijing, Beijing Municipality 100044 China
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.