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Recruiting
NCT07743983
A Study of BGM0504 in Early T2DM With Obesity
Conditions: Type 2 Diabetes (T2DM)
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 372
Sponsor: BrightGene Bio-Medical Technology Co., Ltd.
Location: Nanjing Drum Tower Hospital（The Affiliated Hospital of Nanjing University Medical School） Nanjing Jiangsu
Summary
This trial is conducted in China. The aim is to compare BGM0504 Injection 15 mg with semaglutide 1.0 mg in Chinese T2DM patients with obesity and inadequate control despite diet and exercise. Over 52 weeks of once weekly treatment, efficacy and safety are evaluated, including the rate of diabetes remission at 12 weeks after treatment discontinuation.
Eligibility Criteria
Inclusion Criteria:
* ○ Have been diagnosed with type 2 diabetes mellitus (T2DM)， disease duration ≤5 years, treatment naïve with ≥8 weeks diet/exercise, or off antidiabetic therapy ≥8 weeks prior to screening.
* BMI 28.0-35.0 kg/m² at screening, with stable weight (±5%) for 3 months prior to screening.
* Have HbA1c between ≥7.5% and ≤10.5% at screening.
* FPG ≤15.0 mmol/L at screening.
* If hypertensive: SBP \
Source: ClinicalTrials.gov (NCT07743983). StuddyBuddy aggregates publicly available trial information.
