A Phase 3 interventional study of BGM0504 and semaglutide in Type 2 Diabetes (T2DM), sponsored by BrightGene Bio-Medical Technology Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by BrightGene Bio-Medical Technology Co., Ltd. · Phase 3, Interventional, and Treatment
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 372 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →BrightGene Bio-Medical Technology Co., Ltd. is the lead sponsor of 17 studies on the registry; 12 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
○ 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.
Exclusion Criteria:
● Previous diagnosis of type 1 diabetes, special type diabetes or gestational diabetes.
Drug: BGM0504
Drug: semaglutide
Administered as a subcutaneous injection once weekly for 52 weeks.
Administered as a subcutaneous injection once weekly for 52 weeks.
Proportion 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.
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
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BrightGene Bio-Medical Technology Co., Ltd.