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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
372
Administered as a subcutaneous injection once weekly for 52 weeks.
Administered as a subcutaneous injection once weekly for 52 weeks.
Nanjing Drum Tower Hospital(The Affiliated Hospital of Nanjing University Medical School)
Nanjing, Jiangsu, China
RECRUITINGProportion of Participants Achieving HbA1c < 7.0% and Body Weight Reduction ≥ 10% from Baseline
Composite endpoint assessing both glycemic control and weight loss.
Time frame: Week 52
Proportion of Participants Achieving Diabetes Remission
Defined as HbA1c \< 6.5% without use of glucose-lowering medications.
Time frame: Week 64 (12 weeks off treatment)
Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥10% from Baseline
Composite endpoint assessing combined glycemic and weight outcomes at multiple thresholds.
Time frame: Weeks 12, 24, 36, 44
Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥ 5%, or 15% from Baseline
Composite endpoint assessing combined glycemic and weight outcomes at multiple thresholds.
Time frame: Weeks 12, 24, 36, 44, 52
Proportion of Participants Achieving HbA1c Targets (< 7.0%, ≤ 6.5%, < 5.7%)
Glycemic control assessed at each visit.
Time frame: Weeks 12, 24, 36, 44, 52
Proportion of Participants Achieving HbA1c ≤ 6.5% or < 5.7% with Weight Reduction ≥ 5%, 10%, or 15% from Baseline
Composite endpoint assessing stricter glycemic targets combined with weight loss.
Time frame: Weeks 12, 24, 36, 44, 52
Proportion of Participants Achieving Glycemic and Weight Targets at 12 Weeks Off Treatment
Composite of HbA1c \< 5.7% or \< 6.5% with weight reduction ≥ 5% or ≥ 10%, assessing durability of response after treatment withdrawal.
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Time frame: Week 64
Change from Baseline in HbA1c
Absolute change in glycated hemoglobin from baseline.
Time frame: Weeks 12, 24, 36, 44, 52
Change from Baseline in Fasting Plasma Glucose (FPG)
Absolute change in fasting glucose from baseline.
Time frame: Weeks 12, 24, 36, 44, 52
Change from Baseline in 2-Hour Postprandial Glucose
Glucose measured 2 hours after a standard meal, absolute change from baseline.
Time frame: Week 52
Change from Baseline in Body Weight
Absolute and percentage change in body weight
Time frame: Weeks 12, 24, 36, 44, 52
Change from Baseline in BMI
Absolute and percentage change in BMI (kg/m²).
Time frame: Weeks 12, 24, 36, 44, 52
Change from Baseline in Waist Circumference and Hip Circumference
Absolute change in waist and hip circumference from baseline.
Time frame: Weeks 12, 24, 36, 44, 52
Proportion of Participants Achieving Weight Reduction ≥ 5%, 10%, 15%, and 20% from Baseline
Categorical weight loss responders at multiple thresholds.
Time frame: Weeks 12, 24, 36, 44, 52
Percentage Change from Baseline in Lipid Profile (TC, TG, LDL-C, HDL-C)
Percentage change in total cholesterol, triglycerides, LDL-C, and HDL-C from baseline.
Time frame: Weeks 12, 24, 36, 44, 52
Change from Baseline in Systolic and Diastolic Blood Pressure (SBP/DBP)
Absolute change in seated SBP and DBP from baseline.
Time frame: Weeks 12, 24, 36, 44, 52
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Includes adverse events, serious adverse events, and hypoglycemic events.
Time frame: Baseline to 64 weeks