RecruitingPhase 3NCT07060456

Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin

A Phase III, Multicenter, Randomized, Double Blinded, Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 Versus Placebo in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin.


Sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Enrollment

300 participants

Start Date

Jul 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study is being conducted to evaluate the efficacy and safety of HRS9531 compared with placebo in participants with type 2 diabetes mellitus not adequately controlled with basal insulin, with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study may include up to 23 visits.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing HRS9531, a new injectable medication, in people with type 2 diabetes who are already on daily basal insulin. The goal is to see whether adding HRS9531 can further lower blood sugar levels and potentially reduce the amount of insulin needed. **You may be eligible if...** - You are an adult (male or female) with type 2 diabetes diagnosed at least 90 days ago - You are currently on a stable daily dose of basal insulin alone or combined with metformin and/or an SGLT2 inhibitor (like empagliflozin or dapagliflozin) - Your HbA1c (a measure of average blood sugar over 3 months) is between 7.5% and 11.0% - Your BMI is 22 or higher **You may NOT be eligible if...** - You have type 1 diabetes - You are on other diabetes medications beyond basal insulin, metformin, or SGLT2 inhibitors - You have a history of pancreatitis or thyroid tumors - You have significant kidney, liver, or heart disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHRS9531

HRS9531-low dose

DRUGHRS9531

HRS9531-high dose

DRUGPlacebo

Placebo


Locations(1)

Perking University Peoples' Hospital

Beijing, Beijing Municipality, China

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NCT07060456


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