Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: HRS9531 injection
* Drug: HRS9531 injection Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening. 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. Present or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other more serious mental illness. Surgery is planned during the trial. Mentally incapacitated or speech-impaired. Pregnant or lactating woman. In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A multi-center, randomized, double-blind, placebo- parallel controlled Phase II clinical study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A<br>HRS9531 injection dose level 1 | Drug: HRS9531 injection<br>* single dose<br>|
| Experimental: Treatment group B<br>HRS9531 injection dose level 2 | Drug: HRS9531 injection<br>* single dose<br>|
| Experimental: Treatment group C<br>HRS9531 injection dose level 3 | Drug: HRS9531 injection<br>* single dose<br>|
| Experimental: Treatment group D<br>HRS9531 injection dose level 4 | Drug: HRS9531 injection<br>* single dose<br>|
| Placebo Comparator: Treatment group E<br>HRS9531 injection Placebo dose level 1 | Drug: HRS9531 injection Placebo<br>* single dose<br>|
| Placebo Comparator: Treatment group F<br>HRS9531 injection Placebo dose level 2 | Drug: HRS9531 injection Placebo<br>* single dose<br>|
| Placebo Comparator: Treatment group G<br>HRS9531 injection Placebo dose level 3 | Drug: HRS9531 injection Placebo<br>* single dose<br>|
| Placebo Comparator: Treatment group H<br>HRS9531 injection Placebo dose level 4 | Drug: HRS9531 injection Placebo<br>* single dose<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |