Suspended

HRS9531 Injection for Type 2 Diabetes Management

What is being tested

HRS9531 Injection

+ HRS9531 Placebo Injection

Drug

Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

Over 18 Years

+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 3

Interventional

Study Start: November 2024

See protocol details

Summary

Principal SponsorFujian Shengdi Pharmaceutical Co., Ltd.

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: November 8, 2024

Actual date on which the first participant was enrolled.

This study focuses on understanding how well a new treatment, called HRS9531, works for people with Type 2 Diabetes who haven't been able to control their blood sugar levels through diet and exercise alone. The study aims to see if HRS9531 can effectively lower blood sugar levels over a 24-week period. Diabetes management is crucial for preventing complications, so finding effective treatments can significantly improve the quality of life for those affected. Participants in this study are randomly divided into groups, with some receiving the HRS9531 injection and others receiving a placebo, which is a harmless substance used for comparison. This process is done without revealing to the participants which treatment they are receiving, maintaining the study’s double-blind nature. The effectiveness of HRS9531 is evaluated by monitoring blood sugar levels over the course of the treatment, and the study also looks at the safety of the medication to ensure it does not cause significant side effects.

Official TitleA Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase III Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Type 2 Diabetes， Inadequately Controlled With Diet and Exercise Alone

NCT06650007

Principal SponsorFujian Shengdi Pharmaceutical Co., Ltd.

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

218 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

4 inclusion criteria required to participate

Males and females, Age ≥18 years at the time of signing informed consent.

Diagnosed with type 2 diabetes mellitus (T2DM) for at least 90 days prior to day of screening.

Treatment with Diet and Exercise alone at least 90 days prior to day of screening.

7.5% ≤ HbA1c ≤10.0% at screening.

6 exclusion criteria prevent from participating

Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.

Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.

History of significant hematological disorders (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or other conditions causing hemolysis or instability of red blood cells (e.g., malaria, hypersplenism, etc.).

Presence of an endocrine disorder or history that may significantly affect bady weight(e.g., Cushing's syndrome, hypothyroidism or hyperthyroidism, except hypothyroidism if thyroid hormone replacement dose has been stable for at least 6 months) ；

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Placebo

Group IV

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

The Second Xiangya Hospital of Central South University

Changsha, ChinaOpen The Second Xiangya Hospital of Central South University in Google Maps

SuspendedOne Study Center