Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects

May 5, 2025 updated by: Fujian Shengdi Pharmaceutical Co., Ltd.

A 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

To evaluate the efficacy and dose-response relationship of HRS9531 injection versus placebo in controlling blood glucose after 20 weeks of treatment in subjects with type 2 diabetes who have suboptimal glycaemic control after conventional lifestyle or metformin intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
199

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250021
        • Shandong Provincial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female subjects ,18-65 years of age, agreed and signed the informed consent
  2. Type 2 diabetes mellitus diagnosed for at least 6 months before the screening visit.
  3. Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
  4. HbA1c 7.5-10.5% (both inclusive) at screening visit.

Exclusion Criteria:

  1. Presence of any clinically significant results in examination at screening visit.
  2. Uncontrollable hypertension.
  3. A history of type 1 diabetes, specific diabetes, or secondary diabetes.
  4. Acute diabetic complications or severe hypoglycemia events within 12 months prior to screening.
  5. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening.
  6. Any organ-system malignancies developed within 5 years except for cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.
  7. Present or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other more serious mental illness.
  8. Surgery is planned during the trial.
  9. Mentally incapacitated or speech-impaired.
  10. Pregnant or lactating woman.
  11. In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group A
HRS9531 injection dose level 1
Drug: HRS9531 injection
single dose
Experimental: Treatment group B
HRS9531 injection dose level 2
Drug: HRS9531 injection
single dose
Experimental: Treatment group C
HRS9531 injection dose level 3
Drug: HRS9531 injection
single dose
Experimental: Treatment group D
HRS9531 injection dose level 4
Drug: HRS9531 injection
single dose
Placebo Comparator: Treatment group E
HRS9531 injection Placebo dose level 1
Drug: HRS9531 injection Placebo
single dose
Placebo Comparator: Treatment group F
HRS9531 injection Placebo dose level 2
Drug: HRS9531 injection Placebo
single dose
Placebo Comparator: Treatment group G
HRS9531 injection Placebo dose level 3
Drug: HRS9531 injection Placebo
single dose
Placebo Comparator: Treatment group H
HRS9531 injection Placebo dose level 4
Drug: HRS9531 injection Placebo
single dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change From Baseline in HbA1c after 20 weeks of treatment
Time Frame: Week 0 to Week 20
Week 0 to Week 20

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 20 weeks of treatment
Time Frame: Week 0 to Week 20
Week 0 to Week 20
Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 32 weeks of treatment
Time Frame: Week 0 to Week 32
Week 0 to Week 32
Change From Baseline in HbA1c after 32 weeks
Time Frame: Week 0 to Week 32
Week 0 to Week 32
Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 20 weeks of treatment
Time Frame: Week 0 to Week 20
Week 0 to Week 20
Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 32 weeks of treatment
Time Frame: Week 0 to Week 32
Week 0 to Week 32
Change from baseline body Weight and waist circumference after 20 weeks of treatment
Time Frame: Week 0 to Week 20
Week 0 to Week 20
Change from baseline in body Weight and waist circumference after 32 weeks of treatment
Time Frame: Week 0 to Week 32
Week 0 to Week 32
Number of Participants With Anti-HRS9531 Antibody
Time Frame: Week 0 to Week 36
Week 0 to Week 36
Number of AEs During the Trial
Time Frame: Week 0 to Week 36
Week 0 to Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 12, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 24, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 24, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HRS9531-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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