A Multicenter, Randomized, Open-label, Parallel-controlled, Phase 3 Study to Compare the Efficacy and Safety of HDM1005 Versus Mazdutide in Subjects With T2DM Inadequate Glycemic Control by Metformin Monotherapy or in Combination With a Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 912
- 试验地点
- 1
- 主要终点
- Change from baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
This study is a multicenter, randomized, open-label, parallel-group, phase 3 clinical trial aimed at evaluating the efficacy and safety of HDM1005 versus active comparator in subjects with Type 2 Diabetes Mellitus (T2DM) Inadequate Glycemic Control by Metformin Monotherapy or in Combination With a Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor.
A total of 912 subjects will be enrolled. All subjects will be stratified by baseline HbA1c levels (≤8.5% or >8.5%) and metformin monotherapy (yes or no), then randomized 1:1:1 to: Group 1 (HDM1005), Group 2 (HDM1005), and Group 3 (active comparator), with 304 subjects in each treatment group. All treatment groups will implement dose titration to achieve the target dose.
The study consists of: up to 2-week screening, 2-week run-in, 40-week core treatment, 12-week extension treatment, and 4-week follow-up, totaling 60 weeks. The end-of-study visit will be conducted 28 days after the last administration cycle.
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
- •Confirmed as Type 2 Diabetes Mellitus (T2DM) for at least 12 weeks and on a stable dosage of metformin alone or in combination with an SGLT2 inhibitor for at least 12 weeks prior to screening.
- •Hemoglobin A1c (HbA1c) ≥7.5% and ≤11.0% (local laboratory) at screening; and ≥7.0% and ≤11.0% (central laboratory) at randomization.
- •Body Mass Index (BMI) ≥22.5 kg/m2.
排除标准
- •Other types of diabetes besides T2DM.
- •Acute complications of diabetes (such as diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar non-ketotic coma) occurred within 24 weeks prior to signing the Informed Consent Form (ICF).
- •History of a level 3 hypoglycemic episode or a history of asymptomatic hyp oglycemic episodes within 24 weeks prior to signing the ICF.
- •History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).
- •History of acute or chronic pancreatitis; or presence of risk factors for pancreatitis; or history of symptomatic gallbladder disease requiring treatment per investigator's assessment within 24 weeks prior to signing the ICF.
- •Investigator determines that the subject has a condition or disease affecting gastric emptying or gastrointestinal nutrient absorption, such as weight-loss surgery or other gastric resections, irritable bowel syndrome, dyspepsia, or gastroparesis.
- •Use of antidiabetic medications within 12 weeks prior to signing the ICF, with the exception of metformin monotherapy or combination therapy with an SGLT2 inhibitor; excluding short-term insulin use (cumulative duration ≤7 days) for concomitant illness, stress, or perioperative periods.
- •Hemoglobin (Hb) <100 g/L (female) or <110 g/L (male).
- •FPG ≥13.9 mmol/L.
- •Aspartate aminotransferase (AST) >3× upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3× ULN.
- •Total bilirubin >1.5× ULN.
- •Fasting triglyceride (TG) >5.6 mmol/L (500 mg/dL).
研究组 & 干预措施
Experimental group: HDM1005 1
HDM1005 administered subcutaneously (SC)
干预措施: HDM1005 1 (Drug)
Experimental group: HDM1005 2
HDM1005 administered SC
干预措施: HDM1005 2 (Drug)
Active Comparator: Mazdutide
Mazdutide administered SC
干预措施: Mazdutide (Drug)
结局指标
主要结局
Change from baseline in Hemoglobin A1c (HbA1c)
时间窗: Baseline, Week 40
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.
次要结局
- Change from baseline in HbA1c(Baseline, Week 52)
- The percentage of patients reaching the HbA1c targets of <7.0%, ≤6.5%, and <5.7%(Week 40, Week 52)
- Change from baseline in fasting plasma glucose (FPG)(Baseline, Week 40, Week 52)
- Change from baseline in body weight(Baseline, Week 40, Week 52)