NCT07743983招募中3 期
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）
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 372
- 试验地点
- 1
- 主要终点
- Proportion of Participants Achieving HbA1c < 7.0% and Body Weight Reduction ≥ 10% from Baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •○ 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.
排除标准
- •● 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.
结局指标
主要结局
Proportion of Participants Achieving HbA1c < 7.0% and Body Weight Reduction ≥ 10% from Baseline
时间窗: Week 52
Composite endpoint assessing both glycemic control and weight loss.
次要结局
- Proportion of Participants Achieving Diabetes Remission(Week 64 (12 weeks off treatment))
- Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥10% from Baseline(Weeks 12, 24, 36, 44)
- Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥ 5%, or 15% from Baseline(Weeks 12, 24, 36, 44, 52)
- Proportion of Participants Achieving HbA1c Targets (< 7.0%, ≤ 6.5%, < 5.7%)(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(Weeks 12, 24, 36, 44, 52)
- Proportion of Participants Achieving Glycemic and Weight Targets at 12 Weeks Off Treatment(Week 64)
- Change from Baseline in HbA1c(Weeks 12, 24, 36, 44, 52)
- Change from Baseline in Fasting Plasma Glucose (FPG)(Weeks 12, 24, 36, 44, 52)
- Change from Baseline in 2-Hour Postprandial Glucose(Week 52)
- Change from Baseline in Body Weight(Weeks 12, 24, 36, 44, 52)
- Change from Baseline in BMI(Weeks 12, 24, 36, 44, 52)
- Change from Baseline in Waist Circumference and Hip Circumference(Weeks 12, 24, 36, 44, 52)
- Proportion of Participants Achieving Weight Reduction ≥ 5%, 10%, 15%, and 20% from Baseline(Weeks 12, 24, 36, 44, 52)
- Percentage Change from Baseline in Lipid Profile (TC, TG, LDL-C, HDL-C)(Weeks 12, 24, 36, 44, 52)
- Change from Baseline in Systolic and Diastolic Blood Pressure (SBP/DBP)(Weeks 12, 24, 36, 44, 52)
- Incidence of Treatment-Emergent Adverse Events (TEAEs)(Baseline to 64 weeks)
研究者
研究点 (1)
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