DRUG
HRS9531
Administrated SC
Status
Completed
Phase
Phase 1
Enrollment
64
Locations
1
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
Administrated SC
DRUG
Administrated SC
DRUG
Administrated SC
Timeline
First posted
Aug 26, 2022
Study start
Oct 12, 2022
Primary completion
May 24, 2023
Study completion
May 24, 2023
Results posted
Not reported
Registry updated
Nov 15, 2024
Outcomes
Incidence of Adverse Events (Safety and Tolerability)
Time frame · Screening period up to Day 62
A summary of adverse events, including serious adverse events (SAEs) and Hypoglycemic Events
Area Under the Concentration Versus Time Curve (AUC) of HRS9531
Time frame · Start of Treatment up to Day 62
Maximum Concentration (Cmax) of HRS9531
Time frame · Start of Treatment up to Day 62
Change from Baseline in Fasting Blood Glucose (FBG)
Time frame · Baseline up to Day 62
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame · Baseline up to Day 29
Change from Baseline in Weight
Time frame · Baseline up to Day 62
Immunogenicity: anti-HRS9531 antibody
Time frame · Start of Treatment up to Day 62
Eligibility
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.
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Publications
No PMID-linked publications were present in this registry snapshot.
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