Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin
NCT ID: NCT07060456
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2025-07-25
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment group A: HRS9531-low dose
HRS9531
HRS9531-low dose
Treatment group B: HRS9531-high dose
HRS9531
HRS9531-high dose
Treatment group C
Placebo
Placebo
Interventions
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HRS9531
HRS9531-low dose
HRS9531
HRS9531-high dose
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Fujian Shengdi Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Perking University Peoples' Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Other Identifiers
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HRS9531-305
Identifier Type: -
Identifier Source: org_study_id
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