Clinical trial NCT05516966: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes Mellitus
Official title: A Phase 1, Randomized, Double-Blind, Placebo- and Positive-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: HRS9531 injection compared with placebo and open positive-controlled group
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Males and infertility females, 18-65 years of age, inclusive, on the date of signing informed consent.
2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months.
3. Treated with conventional lifestyle intervention alone or stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
4. 7.0% ≤ HbA1c ≤10.5% at screening.

Exclusion Criteria:

1. 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.
2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
3. 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.
4. Have a presence of proliferative diabetic retinopathy, diabetic macular edema, or nonproliferative diabetic retinopathy requiring treatment during the trial;
5. Participants in clinical trials of any drug or medical device in the 3 months prior to screening.
6. Breast-feeding women.
7. The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.

Primary outcomes:
measure: Incidence of Adverse Events (Safety and Tolerability)
timeFrame: Screening period up to Day 62
Secondary outcomes:
measure: Area Under the Concentration Versus Time Curve (AUC) of HRS9531
timeFrame: Start of Treatment up to Day 62
measure: Maximum Concentration (Cmax) of HRS9531
timeFrame: Start of Treatment up to Day 62
measure: Change from Baseline in Fasting Blood Glucose (FBG)
timeFrame: Baseline up to Day 62
measure: Change from Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline up to Day 29
measure: Change from Baseline in Weight
timeFrame: Baseline up to Day 62
measure: Immunogenicity: anti-HRS9531 antibody
timeFrame: Start of Treatment up to Day 62
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
state: Shanghai
Study officials:
References: