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

Phase 2

Not yet recruiting

• Conditions: Type 2 Diabetes
• Interventions: Drug: HRS-7535; Drug: Placebo

• Registration Number: NCT06393348
• Lead 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-28
• Study First Submitted QC: 2024-04-28
• Last Update Submitted: 2024-04-28
• Study First Posted: 2024-05-01
• Last Update Posted: 2024-05-01
• Study Start: 2024-06
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	HRS-7535	Subjects will receive escalated dose of HRS-7535 administered orally
Group C	Placebo	Subjects will receive Placebo administered orally
Group B	HRS-7535	Subjects will receive dose of HRS-7535 administered orally

Primary Outcome Measures

Name	Time	Method
Change in HbA1c from baseline at Week 16	Week 16

Secondary Outcome Measures

Name	Time	Method
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