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

Type 2 Diabetes Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06393348
• Other study ID #: HRS-7535-205
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: November 2025

Study information

• Verified date: April 2024
• Source: Shandong Suncadia Medicine Co., Ltd.
• Contact: Shujin Cheng
• Phone: 0518-82342973
• Email: shujin.cheng[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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?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;

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• HRS-7535
HRS-7535
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Suncadia Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c from baseline at Week 16		Week 16
Secondary	Proportion of subjects achieving HbA1c target of <7.0% at 16 weeks		16 weeks
Secondary	Proportion of subjects achieving HbA1c target of =6.5% at 16 weeks		16 weeks
Secondary	The change in fasting blood glucose from baseline to 16 weeks		16 weeks
Secondary	The change in in body weight from baseline to 16 weeks		16 weeks
Secondary	The change in 7-point SMBG profile from baseline to 16 weeks		16 weeks