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

NCT ID: NCT06393348

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-17
• Study Completion Date: 2025-03-13

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Group A

Subjects will receive escalated dose of HRS-7535 administered orally

Group Type: EXPERIMENTAL

HRS-7535

Intervention Type: DRUG

HRS-7535

Group B

Subjects will receive dose of HRS-7535 administered orally

Group Type: EXPERIMENTAL

HRS-7535

Intervention Type: DRUG

HRS-7535

Group C

Subjects will receive Placebo administered orally

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

HRS-7535

HRS-7535

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Suncadia Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangdong, Guangzhou, China

Countries

China

Other Identifiers

HRS-7535-205

Identifier Type: -

Identifier Source: org_study_id