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

NCT06393348 | Completed Phase 2

• 1 other identifier: HRS-7535-205
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c from baseline at Week 16

  Week 16

Secondary Outcomes (5)

• Proportion of subjects achieving HbA1c target of <7.0% at 16 weeks

  16 weeks

• Proportion of subjects achieving HbA1c target of ≤6.5% at 16 weeks

  16 weeks

• The change in fasting blood glucose from baseline to 16 weeks

  16 weeks

• The change in in body weight from baseline to 16 weeks

  16 weeks

• The change in 7-point SMBG profile from baseline to 16 weeks

  16 weeks

Study Arms (3)

Group A

EXPERIMENTAL

Subjects will receive escalated dose of HRS-7535 administered orally

Drug: HRS-7535

Group B

EXPERIMENTAL

Subjects will receive dose of HRS-7535 administered orally

Drug: HRS-7535

Group C

PLACEBO COMPARATOR

Subjects will receive Placebo administered orally

Drug: Placebo

Interventions

HRS-7535 DRUG

HRS-7535

Group A; Group B

Placebo DRUG

Placebo

Group C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

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

Guangdong, Guangzhou, 51020, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: May 1, 2024
• Study Start: May 17, 2024
• Primary Completion: November 15, 2024
• Study Completion: March 13, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

CN (1)