| Trial ID: | L2804 |
| Source ID: | NCT05966272
|
| Associated Drug: |
Hrs9531 Injection
|
| Title: |
Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects
|
| Acronym: |
|
| Status: |
ACTIVE_NOT_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: HRS9531 injection|DRUG: HRS9531 injection Placebo
|
| Outcome Measures: |
Primary: Change From Baseline in HbA1c after 20 weeks of treatment, Week 0 to Week 20 | Secondary: 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 HbA1c after 32 weeks, Week 0 to Week 32|Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 20 weeks of treatment, Week 0 to Week 20|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|Change from baseline in body Weight and waist circumference after 32 weeks of treatment, Week 0 to Week 32|Number of Participants With Anti-HRS9531 Antibody, Week 0 to Week 36|Number of AEs During the Trial, Week 0 to Week 36
|
| Sponsor/Collaborators: |
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
199
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2023-08-12
|
| Completion Date: |
2024-08-20
|
| Results First Posted: |
|
| Last Update Posted: |
2023-12-22
|
| Locations: |
Shandong Provincial Hospital, Jinan, Shandong, 250021, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05966272
|
