NCT06393348
Completed
Phase 2
A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Phase ⅡStudy to Evaluate the Efficacy and Safety of HRS-7535 in T2DM Subjects Poorly Controlled With Metformin and SGLT2i.
Shandong Suncadia Medicine Co., Ltd.1 site in 1 country155 target enrollmentMay 17, 2024
Overview
- Phase
- Phase 2
- Intervention
- HRS-7535
- Conditions
- Type 2 Diabetes
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Enrollment
- 155
- Locations
- 1
- Primary Endpoint
- Change in HbA1c from baseline at Week 16
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
2 weeks screening period, 3 weeks run-in period, 16 weeks double-blind treatment period, to evaluate the Safety and Efficacy of HRS-7535 in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin and SGLT2i.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subjects, 18-75 years of age at the time of signing informed consent;
- •Have T2DM (based on the 2020 Chinese Diabetes Society \[CDS\] diagnostic criteria)
- •HbA1c为7.5%≤HbA1c≤11.0% at the screening visit；
- •FPG≤15 mmol/L at the screening visit;
- •Have been treated with an SGLT2i with metformin, for at least 8 weeks;
- •At screening and random visit, 20.0 ≤BMI≤ 35.0 kg/m2;
- •Able and willing to provide a written informed consent
Exclusion Criteria
- •Have type 1 diabetesmellitus;
- •History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
- •Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix;
- •history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
- •Surgery is planned during the trial;
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
Arms & Interventions
Group A
Subjects will receive escalated dose of HRS-7535 administered orally
Intervention: HRS-7535
Group B
Subjects will receive dose of HRS-7535 administered orally
Intervention: HRS-7535
Group C
Subjects will receive Placebo administered orally
Intervention: Placebo
Outcomes
Primary Outcomes
Change in HbA1c from baseline at Week 16
Time Frame: Week 16
Secondary Outcomes
- The change in in body weight from baseline to 16 weeks(16 weeks)
- Proportion of subjects achieving HbA1c target of <7.0% at 16 weeks(16 weeks)
- The change in fasting blood glucose from baseline to 16 weeks(16 weeks)
- The change in 7-point SMBG profile from baseline to 16 weeks(16 weeks)
- Proportion of subjects achieving HbA1c target of ≤6.5% at 16 weeks(16 weeks)
Study Sites (1)
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