A Study of BGM0504 in Early T2DM With Obesity

Официальное название

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）

Обзор

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.

Вмешательства

• Препарат BGM0504
  Administered as a subcutaneous injection once weekly for 52 weeks.
• Препарат semaglutide
  Administered as a subcutaneous injection once weekly for 52 weeks.

Первичные конечные точки

• Proportion of Participants Achieving HbA1c < 7.0% and Body Weight Reduction ≥ 10% from Baseline [Срок оценки: Week 52]

Вторичные конечные точки (12)

• Proportion of Participants Achieving Diabetes Remission [Срок оценки: Week 64 (12 weeks off treatment)]
• Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥10% from Baseline [Срок оценки: Weeks 12, 24, 36, 44]
• Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥ 5%, or 15% from Baseline [Срок оценки: Weeks 12, 24, 36, 44, 52]
• Proportion of Participants Achieving HbA1c Targets (< 7.0%, ≤ 6.5%, < 5.7%) [Срок оценки: 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 [Срок оценки: Weeks 12, 24, 36, 44, 52]
• Proportion of Participants Achieving Glycemic and Weight Targets at 12 Weeks Off Treatment [Срок оценки: Week 64]
• Change from Baseline in HbA1c [Срок оценки: Weeks 12, 24, 36, 44, 52]
• Change from Baseline in Fasting Plasma Glucose (FPG) [Срок оценки: Weeks 12, 24, 36, 44, 52]
• Change from Baseline in 2-Hour Postprandial Glucose [Срок оценки: Week 52]
• Change from Baseline in Body Weight [Срок оценки: Weeks 12, 24, 36, 44, 52]
• Change from Baseline in BMI [Срок оценки: Weeks 12, 24, 36, 44, 52]
• Change from Baseline in Waist Circumference and Hip Circumference [Срок оценки: Weeks 12, 24, 36, 44, 52]

Критерии участия

Критерии включения

• ○ 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.

Критерии исключения

• ● 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Nanjing Drum Tower Hospital（The Affiliated Hospital of Nanjing University Medical School） — Нанкин

Идентификаторы

NCT: NCT07743983 · BGM0504-Ⅲ -T2DM-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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