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NCT06393348 | Not yet recruiting | Type 2 Diabetes

Efficacy and Safety of HRS-7535 Tablets in T2DM Subjects Poorly Controlled With Metformin and SGLT2i.
Sponsor:

Shandong Suncadia Medicine Co., Ltd.

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.

Condition or disease

Type 2 Diabetes

Intervention/treatment

HRS-7535

Placebo

Phase

Phase 2

Study Type : Interventional
Estimated Enrollment : 150 participants
Masking : Double
Primary Purpose : Other
Official Title : 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.
Actual Study Start Date : June 2024
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2025
Arm Intervention/treatment

Experimental: Group A

Subjects will receive escalated dose of HRS-7535 administered orally

Drug: HRS-7535

Experimental: Group B

Subjects will receive dose of HRS-7535 administered orally

Drug: HRS-7535

Placebo Comparator: Group C

Subjects will receive Placebo administered orally

Drug: Placebo
Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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;
Efficacy and Safety of HRS-7535 Tablets in T2DM Subjects Poorly Controlled With Metformin and SGLT2i.

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Efficacy and Safety of HRS-7535 Tablets in T2DM Subjects Poorly Controlled With Metformin and SGLT2i.

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