A Phase II Randomized, Double-blind, Multi-center Study to Investigate the Efficacy and Safety of PG-102(MG12) Compared With Placebo in Subjects With Obesity and in Subjects With Type 2 Diabetes Mellitus (T2DM)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 144
- 试验地点
- 14
- 主要终点
- Change in Glycated Hemoglobin (HbA1c) in Cohort A
研究概览
简要总结
This is a Phase 2, therapeutic exploratory study designed to evaluate the safety and efficacy of PG-102 compared with placebo. Part A includes Cohort A, comprising participants with type 2 diabetes mellitus (T2DM). Part B includes two cohorts: Cohort B1, enrolling participants with obesity, and Cohort B2, enrolling participants with both obesity and T2DM.
详细描述
The study will be conducted in two parts, A and B, with a total of six cohorts. Part A will involve two cohorts comprising patients with type 2 diabetes, while Part B will include four cohorts of patients with obesity.
Part A (T2DM): In Part A, subjects with type 2 diabetes will receive multiple doses of the study drug over a 12-week period, with varying dosing schedules across the two cohorts, to evaluate the safety and efficacy of PG-102 (MG12).
Part B (OB): In Part B, subjects with obesity will receive multiple doses of the study drug over a 12-week period, with varying dosing schedules across the four cohorts to evaluate the safety and efficacy of PG-102 (MG12) in this subgroup. Cohort B2 will include subjects who are both obese and have type 2 diabetes.
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
- Double (Participant, Investigator)
盲法说明
Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 to 75 years who provide informed consent.
- •[Part A: Type 2 Diabetes Mellitus (T2DM) Specific Criteria]
- •Diagnosed with type 2 diabetes for at least 6 months, with HbA1c between 7.0% and 10.0%, despite adherence to diet and exercise therapy according to diabetes treatment guidelines.
- •Stable on metformin monotherapy or metformin in combination with one oral hypoglycemic agent for at least 90 days.
- •BMI between 18.5 kg/m² and 30.0 kg/m², with a minimum weight of 55 kg for men and 50 kg for women.
- •[Part B: Obesity (OB) Specific Criteria]
- •Failed at least one attempt at weight loss through diet and exercise.
- •Cohort B1: BMI ≥ 30 kg/m²
- •Cohort B2: BMI ≥ 27 kg/m² 8-
- •Cohort B2: Diagnosed with type 2 diabetes for at least 6 months, with HbA1c between 7.0% and 10.0%.
- •Cohort B2: Received treatment with diet and exercise alone, OR stable on approved oral antidiabetic monotherapy or combination therapy for at least 90 days prior to screening.
排除标准
- •Participation in another clinical trial within 90 days.
- •Known hypersensitivity to study drugs or their components.
- •Inability to administer the drug in the abdomen.
- •History of severe gastrointestinal disorders, recent obesity-related surgeries, or conditions affecting gastric emptying.
- •Uncontrolled severe hypertension, hypertriglyceridemia, or severe cardiovascular disease.
- •History of acute pancreatitis, recent cancer, or endocrine disorders causing obesity.
- •Abnormal lab results, including eGFR < 60 mL/min/1.73 m², AST/ALT > 3x ULN, or abnormal ECG.
- •Substance abuse or significant psychiatric disorders within the last 2 years.
- •Pregnant, breastfeeding, or unwilling to use contraception during the study.
研究组 & 干预措施
Cohort A
Cohort A will include two sub-cohorts with different dosing schedules in participants diagnosed with type 2 diabetes.
干预措施: PG-102 (Biological)
Cohort B1
Cohort B1 will include two sub-cohorts with different dosing schedules in participants with obesity.
干预措施: PG-102 (Biological)
Cohort B2
Cohort B2 will include two sub-cohorts with different dosing schedules in participants with obesity and type 2 diabetes.
干预措施: PG-102 (Biological)
Cohort A (Placebo)
Cohort A will include two sub-cohorts with different dosing schedules in participants diagnosed with type 2 diabetes.
干预措施: Placebo (Other)
Cohort B1 (Placebo)
Cohort B1 will include two sub-cohorts with different dosing schedules in participants with obesity.
干预措施: Placebo (Other)
Cohort B2 (Placebo)
Cohort B2 will include two sub-cohorts with different dosing schedules in participants with obesity and type 2 diabetes.
干预措施: Placebo (Other)
结局指标
主要结局
Change in Glycated Hemoglobin (HbA1c) in Cohort A
时间窗: Baseline at weeks 14
Percent Change from Baseline in Body Weight in Cohort B1 and B2
时间窗: Baseline at weeks 14
次要结局
- Incidence of Treatment-emergent adverse events (TEAEs) in Cohort A and Cohort B1, B2(Baseline to weeks 20)
- Change from Baseline in HbA1c in Cohort A and B2(Baseline at weeks 4, 8, 12, 14, 16, and 20)
- Percent Change from Baseline in fasting plasma glucose (FPG) in Cohort A and B2(Baseline at weeks 4, 8, 12, 14, 16, and 20)
- Absolute Change from Baseline in fasting plasma glucose in Cohort A and B2(Baseline, Week 4, 8, 12, 14, 16, and 20 weeks)
- Percent Change from Baseline in Body Weight in Cohort B1 and B2(Baseline at weeks 4, 8, 12, 16, and 20)
- Absolute Change from Baseline in Body Weight in Cohort B1 and B2(Baseline at weeks 4, 8, 12, 14, 16, and 20)