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Efficacy and Safety of HRS-7535 Tablets in T2DM Subjects Poorly Controlled With Metformin and SGLT2i. - Trial NCT06393348

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.

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NCT06393348
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06393348
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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 โ…กStudy to Evaluate the Efficacy and Safety of HRS-7535 in T2DM Subjects Poorly Controlled With Metformin and SGLT2i.

Study Focus

Type 2 Diabetes

HRS-7535

Interventional

drug

Sponsor & Location

Shandong Suncadia Medicine Co., Ltd.

Timeline & Enrollment

Phase 2

Jun 01, 2024

Nov 01, 2025

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 mellitus
Type 2 diabetes mellitus without complications
Type 2 diabetes mellitus with unspecified complications
Type 2 diabetes mellitus with other specified complications
Type 2 diabetes mellitus with multiple complications

Data Source

ClinicalTrials.gov

NCT06393348

Non-Device Trial