Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes Mellitus
Phase 1
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT05516966
- Lead Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Brief Summary
The main purpose of this study is to assess the safety and tolerability of multiple subcutaneous injections of HRS9531 in patients with type 2 diabetes mellitus who have suboptimal glycaemic control after conventional lifestyle or metformin intervention.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
- Males and infertility females, 18-65 years of age, inclusive, on the date of signing informed consent.
- Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months.
- Treated with conventional lifestyle intervention alone or stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
- 7.0% ≤ HbA1c ≤10.5% at screening.
Exclusion Criteria
- History or presence of vital organ primary diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, judged by researchers to be unsuitable for this study.
- Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
- Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) or episode of severe hypoglycaemic events within 12 months prior to screening.
- Have a presence of proliferative diabetic retinopathy, diabetic macular edema, or nonproliferative diabetic retinopathy requiring treatment during the trial;
- Participants in clinical trials of any drug or medical device in the 3 months prior to screening.
- Breast-feeding women.
- The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B HRS9531 Participants receive medium dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection Group A Placebo Participants receive low dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection Group C HRS9531 Participants receive high dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection Group C Placebo Participants receive high dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection Group D Dulaglutide Injection Participants receive Dulaglutide 1.5 mg by multiple subcutaneous injection Group A HRS9531 Participants receive low dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection Group B Placebo Participants receive medium dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (Safety and Tolerability) Screening period up to Day 62 A summary of adverse events, including serious adverse events (SAEs) and Hypoglycemic Events
- Secondary Outcome Measures
Name Time Method Change from Baseline in Hemoglobin A1c (HbA1c) Baseline up to Day 29 Area Under the Concentration Versus Time Curve (AUC) of HRS9531 Start of Treatment up to Day 62 Change from Baseline in Fasting Blood Glucose (FBG) Baseline up to Day 62 Maximum Concentration (Cmax) of HRS9531 Start of Treatment up to Day 62 Immunogenicity: anti-HRS9531 antibody Start of Treatment up to Day 62 Change from Baseline in Weight Baseline up to Day 62
Trial Locations
- Locations (1)
Zhongshan Hospital Affiliated to Fudan University
🇨🇳Shanghai, Shanghai, China