| Trial ID: | L4161 |
| Source ID: | NCT06716216
|
| Associated Drug: |
Drug: 5 Mg Bgm0504 Administered Sc
|
| Title: |
A Study of BGM0504 in Participants with Type 2 Diabetes
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus (T2DM)
|
| Interventions: |
DRUG: Drug: 5 mg BGM0504 Administered SC|DRUG: Drug:10 mg BGM0504 Administered SC|DRUG: Drug: Semaglutide Administered SC
|
| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1c (HbA1c), Change from baseline in HbA1c after 32 weeks of treatment., Week 0 to Week 32 | Secondary: Change From Baseline in Body Weight, Change from baseline in body weight after 52 weeks of treatment., Week 0 to Week 52|Change From Baseline in Hemoglobin A1c (HbA1c), Change from baseline in HbA1c after 52weeks of treatment., Week 0 to Week 52|Percentage of Participants With HbA1c Target Value of <7%, Percentage of Participants With HbA1c Target Value of \<7% after 52weeks of treatment., Week 0 to Week 52|Percentage of Participants With HbA1c Target Value of <5.7%, Percentage of Participants With HbA1c Target Value of \<5.7%after 52weeks of treatment., Week 0 to Week 52|Change From Baseline in Fasting Serum Glucose, Change from baseline in FPG after 52 weeks of treatment., Week 0 to Week 52
|
| Sponsor/Collaborators: |
Sponsor: BrightGene Bio-Medical Technology Co., Ltd. | Collaborators: BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
537
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2024-11-29
|
| Completion Date: |
2026-11-14
|
| Results First Posted: |
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| Last Update Posted: |
2025-02-07
|
| Locations: |
Peking University People's Hospital, Beijing, Beijing, 100044, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06716216
|
