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

Shandong Suncadia Medicine

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: HRS-7535; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06393348

HRS-7535-205

Details and patient eligibility

About

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.

Enrollment: 155 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female subjects, 18-75 years of age at the time of signing informed consent;
2. Have T2DM (based on the 2020 Chinese Diabetes Society [CDS] diagnostic criteria)
3. HbA1c为7.5%≤HbA1c≤11.0% at the screening visit；
4. FPG≤15 mmol/L at the screening visit;
5. Have been treated with an SGLT2i with metformin, for at least 8 weeks;
6. At screening and random visit, 20.0 ≤BMI≤ 35.0 kg/m2;
7. Able and willing to provide a written informed consent

Exclusion criteria

1. Have type 1 diabetesmellitus;
2. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
3. 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;
4. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
5. Surgery is planned during the trial;
6. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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155 participants in 3 patient groups, including a placebo group

Group A

Experimental group

Description:

Subjects will receive escalated dose of HRS-7535 administered orally

Treatment:

Drug: HRS-7535

Group B

Experimental group

Description:

Subjects will receive dose of HRS-7535 administered orally

Treatment:

Drug: HRS-7535

Group C

Placebo Comparator group

Description:

Subjects will receive Placebo administered orally

Treatment:

Drug: Placebo