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Completed

NCT Number: NCT06393348

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

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.

Completed

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Guangdong, Guangzhou, 51020, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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;

Treatment and study plan

HRS-7535

Drug

HRS-7535

Placebo

Drug

Placebo

Primary outcomes

  1. Change in HbA1c from baseline at Week 16

    Time frame: Week 16

Secondary outcomes

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

    Time frame: 16 weeks

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

    Time frame: 16 weeks

  3. The change in fasting blood glucose from baseline to 16 weeks

    Time frame: 16 weeks

  4. The change in in body weight from baseline to 16 weeks

    Time frame: 16 weeks

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

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 1, 2024
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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