NCT07060456 Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin
| NCT ID | NCT07060456 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fujian Shengdi Pharmaceutical Co., Ltd. |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-07-25 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2025-07-25 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07060456 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07060456 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT07060456 currently recruiting?
Yes, NCT07060456 is actively recruiting participants. Contact the research team at hong.chen@hengrui.com for enrollment information.
Where is the NCT07060456 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07060456 clinical trial?
NCT07060456 is sponsored by Fujian Shengdi Pharmaceutical Co., Ltd.. The trial plans to enroll 300 participants.
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