Completed

HRS9531 Injection for Blood Glucose Control in Type 2 Diabetes

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Study Aim

This study aims to evaluate the effectiveness of HRS9531 Injection in controlling blood glucose levels in individuals with Type 2 Diabetes, by measuring changes in HbA1c after 20 weeks of treatment.

What is being tested

HRS9531 injection

+ HRS9531 injection Placebo

Drug
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 18 to 65 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: August 2023
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: August 12, 2023

Actual date on which the first participant was enrolled.

This study focuses on evaluating the effectiveness and safety of a treatment called HRS9531 injection in people with type 2 diabetes. The participants are those who have not achieved satisfactory blood sugar control despite lifestyle changes or using metformin. The goal is to understand if HRS9531 can help improve blood sugar management. This research is important as it aims to provide a new treatment option for type 2 diabetes, potentially addressing unmet needs in diabetes care.

Official TitleA Multi-center, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects
NCT05966272
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

199 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.

From 18 to 65 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
Male or female subjects ,18-65 years of age, agreed and signed the informed consent
Type 2 diabetes mellitus diagnosed for at least 6 months before the screening visit.
Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
HbA1c 7.5-10.5% (both inclusive) at screening visit.
11 exclusion criteria prevent from participating
Presence of any clinically significant results in examination at screening visit.
Uncontrollable hypertension.
A history of type 1 diabetes, specific diabetes, or secondary diabetes.
Acute diabetic complications or severe hypoglycemia events within 12 months prior to screening.
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

8 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
HRS9531 injection dose level 1

Group II

Experimental
HRS9531 injection dose level 2

Group III

Experimental
HRS9531 injection dose level 3

Group IV

Experimental
HRS9531 injection dose level 4

Group 5

Placebo
HRS9531 injection Placebo dose level 1

Group 6

Placebo
HRS9531 injection Placebo dose level 2

Group 7

Placebo
HRS9531 injection Placebo dose level 3

Group 8

Placebo
HRS9531 injection Placebo dose level 4

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

Shandong Provincial Hospital

Jinan, ChinaOpen Shandong Provincial Hospital in Google Maps
CompletedOne Study Center