Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects

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: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: HRS9531 injection; Drug: HRS9531 injection Placebo

• Study Type: Interventional
• Enrollment (Actual): 199
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Change From Baseline in HbA1c after 20 weeks of treatment	Week 0 to Week 20

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 20 weeks of treatment	Week 0 to Week 20
Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 32 weeks of treatment	Week 0 to Week 32
Change From Baseline in HbA1c after 32 weeks	Week 0 to Week 32
Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 20 weeks of treatment	Week 0 to Week 20
Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 32 weeks of treatment	Week 0 to Week 32
Change from baseline body Weight and waist circumference after 20 weeks of treatment	Week 0 to Week 20
Change from baseline in body Weight and waist circumference after 32 weeks of treatment	Week 0 to Week 32
Number of Participants With Anti-HRS9531 Antibody	Week 0 to Week 36
Number of AEs During the Trial	Week 0 to Week 36

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2023
• Primary Completion (Actual): September 24, 2024
• Study Completion (Actual): September 24, 2024

Study Registration Dates

• First Submitted: July 21, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID 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