Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects
Phase 2
Completed
- Conditions
- Type 2 Diabetes
- Interventions
- Drug: HRS9531 injection Placebo
- Registration Number
- NCT05966272
- Lead Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 199
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group A HRS9531 injection HRS9531 injection dose level 1 Treatment group G HRS9531 injection Placebo HRS9531 injection Placebo dose level 3 Treatment group F HRS9531 injection Placebo HRS9531 injection Placebo dose level 2 Treatment group B HRS9531 injection HRS9531 injection dose level 2 Treatment group C HRS9531 injection HRS9531 injection dose level 3 Treatment group E HRS9531 injection Placebo HRS9531 injection Placebo dose level 1 Treatment group H HRS9531 injection Placebo HRS9531 injection Placebo dose level 4 Treatment group D HRS9531 injection HRS9531 injection dose level 4
- Primary Outcome Measures
Name Time Method Change From Baseline in HbA1c after 20 weeks of treatment Week 0 to Week 20
- Secondary Outcome Measures
Name Time Method 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 Number of Participants With Anti-HRS9531 Antibody Week 0 to Week 36 Number of AEs During the Trial Week 0 to Week 36 Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 20 weeks of treatment Week 0 to Week 20 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 body Weight and waist circumference after 32 weeks of treatment Week 0 to Week 32 Change From Baseline in HbA1c after 32 weeks Week 0 to Week 32
Trial Locations
- Locations (1)
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China