| Trial ID: | L3306 |
| Source ID: | NCT05516966
|
| Associated Drug: |
Hrs9531
|
| Title: |
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: HRS9531|DRUG: Placebo|DRUG: Dulaglutide Injection
|
| Outcome Measures: |
Primary: Incidence of Adverse Events (Safety and Tolerability), A summary of adverse events, including serious adverse events (SAEs) and Hypoglycemic Events, Screening period up to Day 62 | Secondary: Area Under the Concentration Versus Time Curve (AUC) of HRS9531, Start of Treatment up to Day 62|Maximum Concentration (Cmax) of HRS9531, Start of Treatment up to Day 62|Change from Baseline in Fasting Blood Glucose (FBG), Baseline up to Day 62|Change from Baseline in Hemoglobin A1c (HbA1c), Baseline up to Day 29|Change from Baseline in Weight, Baseline up to Day 62|Immunogenicity: anti-HRS9531 antibody, Start of Treatment up to Day 62
|
| Sponsor/Collaborators: |
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
64
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-10-12
|
| Completion Date: |
2023-05-24
|
| Results First Posted: |
|
| Last Update Posted: |
2024-11-15
|
| Locations: |
Zhongshan Hospital Affiliated to Fudan University, Shanghai, Shanghai, 200000, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05516966
|
