| Trial ID: | L6208 |
| Source ID: | NCT06650007
|
| Associated Drug: |
Hrs9531 Injection
|
| Title: |
the Efficacy and Safety of HRS9531 Injection in Subjects With Type 2 Diabetes， Inadequately Controlled With Diet and Exercise Alone
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: HRS9531 Injection|DRUG: HRS9531 Placebo Injection
|
| Outcome Measures: |
Primary: Change in HbA1c, from baseline to 36 weeks treatment | Secondary: Proportion of subjects with HbA1c<7.0% and ≤6.5%, from baseline to 36 weeks treatment|Change in FPG, from baseline to 36 weeks treatment|Change in body weight, from baseline to 36 weeks treatment|Proportion of subjects with HbA1c<7.0% and weight loss ≥5%, from baseline to 36 weeks treatment
|
| Sponsor/Collaborators: |
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
210
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-11-08
|
| Completion Date: |
2026-07
|
| Results First Posted: |
|
| Last Update Posted: |
2025-01-03
|
| Locations: |
The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410100, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06650007
|
