A Study of BGM0504 in Early T2DM With Obesity
2026年7月29日 更新者：BrightGene Bio-Medical Technology Co., Ltd.
A Randomized, Open-Label, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety, and Diabetes Remission of BGM0504 Injection Compared With Semaglutide Injection in Early-Stage Chinese Type 2 Diabetes Mellitus Patients With Obesity and Inadequate Glycemic and Weight Control Despite Diet and Exercise Intervention（BRIGHT-1）
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.
研究概览
研究类型
介入性
注册 (估计的)
372
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Zhu
- 电话号码：+86025-68182432
- 邮箱：zhudalong@nju.edu.cn
学习地点
-
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Jiangsu
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Nanjing、Jiangsu、中国、210008
- 招聘中
- Nanjing Drum Tower Hospital（The Affiliated Hospital of Nanjing University Medical School）
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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 <180 mmHg and DBP <110 mmHg at enrollment, on stable (≥2 weeks) ≤2 antihypertensives, or no medication with diet/exercise ≥4 weeks.
- Willing to comply with protocol, use effective contraception, and provide informed consent.
Exclusion Criteria:
● Previous diagnosis of type 1 diabetes, special type diabetes or gestational diabetes.
- Prior use of antidiabetics or systemic glucocorticoids within 8 weeks, prior GLP-1/GIP/GCG receptor agonists with intolerance/poor response, or weight-loss drugs within 3 months.
- History of acute/chronic pancreatitis.
- Medullary thyroid carcinoma, MEN 2A/2B, or family history.
- Malignancy within 5 years (except treated BCC/SCC, cervical/PSC/thyroid papillary carcinoma in situ with no recurrence).
- Severe cardiac conditions within 6 months: NYHA III/IV HF, unstable angina, MI, CABG/stent, severe arrhythmias.
- Hemorrhagic or ischemic stroke within 6 months.
- Severe renal disease or eGFR ≤60 mL/min/1.73 m² (CKD-EPI).
- Pregnant or lactating woman.
- Prior clinical trial participation with investigational drug or device within 3 months.
- Other situations that are deemed as inappropriate for participation by investigators.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：BGM0504 Injection 15 mg
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Administered as a subcutaneous injection once weekly for 52 weeks.
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有源比较器：Semaglutide Injection 1.0 mg
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Administered as a subcutaneous injection once weekly for 52 weeks.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of Participants Achieving HbA1c < 7.0% and Body Weight Reduction ≥ 10% from Baseline
大体时间：Week 52
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Composite endpoint assessing both glycemic control and weight loss.
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Week 52
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of Participants Achieving Diabetes Remission
大体时间：Week 64 (12 weeks off treatment)
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Defined as HbA1c < 6.5% without use of glucose-lowering medications.
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Week 64 (12 weeks off treatment)
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Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥10% from Baseline
大体时间：Weeks 12, 24, 36, 44
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Composite endpoint assessing combined glycemic and weight outcomes at multiple thresholds.
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Weeks 12, 24, 36, 44
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Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥ 5%, or 15% from Baseline
大体时间：Weeks 12, 24, 36, 44, 52
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Composite endpoint assessing combined glycemic and weight outcomes at multiple thresholds.
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Weeks 12, 24, 36, 44, 52
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Proportion of Participants Achieving HbA1c Targets (< 7.0%, ≤ 6.5%, < 5.7%)
大体时间：Weeks 12, 24, 36, 44, 52
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Glycemic control assessed at each visit.
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Weeks 12, 24, 36, 44, 52
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Proportion of Participants Achieving HbA1c ≤ 6.5% or < 5.7% with Weight Reduction ≥ 5%, 10%, or 15% from Baseline
大体时间：Weeks 12, 24, 36, 44, 52
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Composite endpoint assessing stricter glycemic targets combined with weight loss.
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Weeks 12, 24, 36, 44, 52
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Proportion of Participants Achieving Glycemic and Weight Targets at 12 Weeks Off Treatment
大体时间：Week 64
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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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Week 64
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Change from Baseline in HbA1c
大体时间：Weeks 12, 24, 36, 44, 52
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Absolute change in glycated hemoglobin from baseline.
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Weeks 12, 24, 36, 44, 52
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Change from Baseline in Fasting Plasma Glucose (FPG)
大体时间：Weeks 12, 24, 36, 44, 52
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Absolute change in fasting glucose from baseline.
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Weeks 12, 24, 36, 44, 52
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Change from Baseline in 2-Hour Postprandial Glucose
大体时间：Week 52
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Glucose measured 2 hours after a standard meal, absolute change from baseline.
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Week 52
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Change from Baseline in Body Weight
大体时间：Weeks 12, 24, 36, 44, 52
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Absolute and percentage change in body weight
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Weeks 12, 24, 36, 44, 52
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Change from Baseline in BMI
大体时间：Weeks 12, 24, 36, 44, 52
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Absolute and percentage change in BMI (kg/m²).
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Weeks 12, 24, 36, 44, 52
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Change from Baseline in Waist Circumference and Hip Circumference
大体时间：Weeks 12, 24, 36, 44, 52
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Absolute change in waist and hip circumference from baseline.
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Weeks 12, 24, 36, 44, 52
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Proportion of Participants Achieving Weight Reduction ≥ 5%, 10%, 15%, and 20% from Baseline
大体时间：Weeks 12, 24, 36, 44, 52
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Categorical weight loss responders at multiple thresholds.
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Weeks 12, 24, 36, 44, 52
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Percentage Change from Baseline in Lipid Profile (TC, TG, LDL-C, HDL-C)
大体时间：Weeks 12, 24, 36, 44, 52
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Percentage change in total cholesterol, triglycerides, LDL-C, and HDL-C from baseline.
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Weeks 12, 24, 36, 44, 52
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Change from Baseline in Systolic and Diastolic Blood Pressure (SBP/DBP)
大体时间：Weeks 12, 24, 36, 44, 52
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Absolute change in seated SBP and DBP from baseline.
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Weeks 12, 24, 36, 44, 52
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Incidence of Treatment-Emergent Adverse Events (TEAEs)
大体时间：Baseline to 64 weeks
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Includes adverse events, serious adverse events, and hypoglycemic events.
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Baseline to 64 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月30日
初级完成 (估计的)
2028年9月30日
研究完成 (估计的)
2028年11月30日
研究注册日期
首次提交
2026年7月24日
首先提交符合 QC 标准的
2026年7月29日
首次发布 (实际的)
2026年8月4日
研究记录更新
最后更新发布 (实际的)
2026年8月4日
上次提交的符合 QC 标准的更新
2026年7月29日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.