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NCT06393348Not yet recruiting

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.
Shandong Suncadia Medicine Co., Ltd.Phase 2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Type 2 Diabetes
Drug/Device/Intervention
HRS-7535
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Shandong Suncadia Medicine Co., Ltd.
Timeline & enrollment
Phase
Phase 2
Start date
Jun 01, 2024
End date
Nov 01, 2025
Enrollment
150 participants
Primary outcome

Change in HbA1c from baseline at Week 16

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.

ICD-10 classifications
Type 2 diabetes mellitusType 2 diabetes mellitus without complicationsType 2 diabetes mellitus with unspecified complicationsType 2 diabetes mellitus with other specified complicationsType 2 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06393348
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06393348 through Pure Global AI's free database. This Phase 2 trial is sponsored by Shandong Suncadia Medicine Co., Ltd. and is currently Not yet recruiting. The study focuses on Type 2 Diabetes. Target enrollment is 150 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.