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

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06393348

Enrollment

155

Registered

2024-05-01

Start date

2024-05-17

Completion date

2025-03-13

Last updated

2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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.

Interventions

DRUGHRS-7535

HRS-7535

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame
Change in HbA1c from baseline at Week 16	Week 16

Secondary

Measure	Time frame
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026