A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

Официальное название

A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of BGM0504 Versus Placebo in Patients with Type 2 Diabetes, Inadequately Controlled with Diet and Exercise Alone

Обзор

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of BGM0504 in patients with type 2 diabetes (T2D) with poor glycemic control only through diet and exercise. The main purpose is to evaluate the clinical efficacy of BGM0504 injection monotherapy for 32 weeks compared with placebo in Chinese patients with type 2 diabetes with poor glycemic control only through diet and exercise, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.

Вмешательства

• Препарат Drug: 5 mg BGM0504 Administered SC
  Drug: BGM0504 Administered SC
• Препарат Drug: : 10 mg BGM0504 Administered SC
  Drug: BGM0504 Administered SC
• Препарат Drug: Placebo Administered SC
  Drug: Placebo Administered SC

Первичные конечные точки

• Change From Baseline in Hemoglobin A1c (HbA1c) [Срок оценки: Week 0 to Week 32]

Вторичные конечные точки (5)

• Change From Baseline in Body Weight [Срок оценки: Week 0 to Week 52]
• Change From Baseline in Hemoglobin A1c (HbA1c) [Срок оценки: Week 0 to Week 52]
• Percentage of Participants With HbA1c Target Value of <7% [Срок оценки: Week 0 to Week 52]
• Percentage of Participants With HbA1c Target Value of <5.7% [Срок оценки: Week 0 to Week 52]
• Change From Baseline in Fasting Serum Glucose [Срок оценки: Week 0 to Week 52]

Критерии участия

Критерии включения

• ☑ Have been diagnosed with type 2 diabetes mellitus (T2DM);

• Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening;
• Be of stable weight (± 5%) for at least 3 months before screening;
• Have HbA1c between ≥7.5% and ≤11.0%；
• Fasting Plasma Glucose (FPG) ≤ 15.0 mmoL/L.

Критерии исключения

• ■ Previous diagnosis of type 1 diabetes, special type diabetes ;

• There are malignant tumors within 5 years before screening, or patients are in latent of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery).
• Have had chronic or acute pancreatitis any time prior to study entry;
• Known allergic constitution (allergy to 3 or more kinds of food or drugs), or allergy to GLP-1 receptor agonists, or severe allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) at screening;
• Mentally incapacitated or speech-impaired;
• Suspected or confirmed history of alcohol or drug abuse;
• Pregnant or lactating woman;
• The investigator considers that there are any other conditions that make it inappropriate to participate in this study.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT06716203 · BGM0504-Ⅲ -T2DM-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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