A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate Efficacy, Safety, and Tolerability of HM15275 for 36 Weeks in Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 15
- 主要终点
- Change in Glycated Hemoglobin (HbA1c)
研究概览
简要总结
This study is a Phase 2 clinical trial to evaluate the efficacy, safety, and tolerability of HM15275 in subjects with type 2 diabetes mellitus over 36 weeks.
详细描述
HM-OBCT-202 is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, parallel-group study designed to evaluate the efficacy, safety, and tolerability of HM15275 treatment over 36 weeks in adults with type 2 diabetes mellitus (T2DM).
The study will enroll adult participants with T2DM (aged 18 to 75 years) who have inadequate glycemic control. Eligible participants must have a body mass index (BMI) ≥25 kg/m² and ≤50 kg/m² and HbA1c between 7.0% and 10.0% at screening.
Participants in this study will be randomly assigned in a 1:1:1:1 ratio to 1 of the 4 treatment arms. Randomization will be stratified by screening HbA1c (≤8.0% versus >8.0%) and use of metformin (yes versus no).
All participants will undergo a 4-week screening period, a 36-week treatment period (including weekly subcutaneous [SC] injection of study drug), and a 4-week safety follow-up period.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Participant's age at the time of signing the informed consent:
- •United States: 18 to 75 years (inclusive)
- •Diagnosed with type 2 diabetes mellitus (T2DM) with HbA1c ≥7.0% and ≤10.0% at screening
- •Treated with diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for at least 3 months prior to screening
- •BMI ≥25 kg/m² and ≤50 kg/m²
- •Body weight change <5% over the past 3 months prior to screening
- •Capable of giving signed informed consent and willing to comply with all protocol procedures
排除标准
- •Type 1 diabetes mellitus or use of glucose-lowering medications other than metformin within 3 months prior to screening
- •Poor glycemic control (fasting plasma glucose >270 mg/dL)
- •History of diabetic ketoacidosis or severe hypoglycemia within 6 months
- •Clinically significant cardiovascular disease (e.g., NYHA class III/IV heart failure, recent myocardial infarction, stroke, or revascularization within 3 months)
- •History of pancreatitis or factors increasing the risk of pancreatitis
- •Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2
- •Clinically significant liver disease, renal impairment (eGFR <60 mL/min/1.73 m²), or abnormal laboratory findings at screening
- •Participation in another investigational study within 30 days or within 5 half-lives of the investigational product, whichever is longer; for GLP-1 receptor agonist-related or weight loss studies, participation within 3 months prior to screening
研究组 & 干预措施
Placebo of HM15275
Participants will receive placebo of HM15275 via subcutaneous (SC) injection.
干预措施: Placebo of HM15275 (Drug)
HM15275
Participants will receive HM15275 via subcutaneous (SC) injection.
干预措施: HM15275 (Drug)
结局指标
主要结局
Change in Glycated Hemoglobin (HbA1c)
时间窗: Up to 41 weeks
Change in HbA1c (%) from randomization to Week 37.
次要结局
- Percentage of participants reaching specified HbA1c (%)(Up to 41 weeks)
- Number of participants with adverse events (AEs)(Up to 41 weeks)