NCT07060456RecruitingPhase 3
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.
Source: ClinicalTrials.gov · Last updated 2 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 22 Jun 2025
- Start date
- 25 Jul 2025
- Primary completion date
- Feb 2027
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT07060456
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 300
- From 25 Jul 2025 to the primary completion date, Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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；
- Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 90 days;
Other illness
- A history of type 1 diabetes, specific diabetes, or secondary diabetes;
- Have a history of malignancy within 5 years;
- Known or suspected allergy or intolerance to the investigational medicinal products or related products;
- Any conditions that the Investigator judges might not be suitable to participate in the trial.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Perking University Peoples' Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.