NCT06858878进行中（未招募）3 期
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2)
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen
- 入组人数
- 1,105
- 试验地点
- 184
- 主要终点
- Percent Change from Baseline in Body Weight at Week 72
研究概览
简要总结
The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.
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)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Body mass index ≥ 27 kg/m^
- •History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
- •Diagnosis of T2DM.
排除标准
- •Type 1 diabetes mellitus.
- •Self-reported change in body weight > 5 kg within 90 days before screening.
- •Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment.
- •Obesity induced by other endocrinologic disorders.
- •Family (first-degree relative[s]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type
- •History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
- •History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
- •Lifetime history of suicide attempt.
研究组 & 干预措施
Maridebart Cafraglutide High Dose
Experimental
Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks.
干预措施: Maridebart cafraglutide (Drug)
Maridebart Cafraglutide Medium Dose
Experimental
Participants will receive maridebart cafraglutide medium dose SC for 72 weeks.
干预措施: Maridebart cafraglutide (Drug)
Maridebart Cafraglutide Low Dose
Experimental
Participants will receive maridebart cafraglutide low dose SC for 72 weeks.
干预措施: Maridebart cafraglutide (Drug)
Placebo
Placebo Comparator
Participants will receive placebo SC for 72 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Weight at Week 72
时间窗: Baseline and Week 72
次要结局
- Change from Baseline in Waist Circumference at Week 72(Baseline and Week 72)
- Participant achieving ≥ 5% reduction in body weight from baseline at week 72(Baseline and Week 72)
- Participant achieving ≥ 10% reduction in body weight from baseline at week 72(Baseline and Week 72)
- Participant achieving ≥ 15% reduction in body weight from baseline at week 72(Baseline and Week 72)
- Change from Baseline in Systolic Blood Pressure (SBP) at Week 72(Baseline and Week 72)
- Percent Change from Baseline in Fasting Triglycerides at Week 72(Baseline and Week 72)
- Change from Baseline in Fasting Plasma Glucose at Week 72(Baseline and Week 72)
- Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72(Baseline and Week 72)
- Participant achieving HbA1c < 7% at week 72(Week 72)
- Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72(Baseline and Week 72)
- Change from Baseline in Body Weight at Week 72(Baseline and Week 72)
- Participant achieving ≥ 20% reduction in body weight from baseline at week 72(Baseline and Week 72)
- Change from Baseline in Body Mass Index (BMI) at Week 72(Baseline and Week 72)
- Percent Change from Baseline in High-sensitivity C-reactive Protein (hs-CRP) at Week 72(Baseline and Week 72)
- Participant achieving HbA1c ≤ 6.5% at week 72(Week 72)
- Participant achieving HbA1c < 5.7%, at week 72(Week 72)
- Percent Change from Baseline in Fasting Insulin at Week 72(Baseline and Week 72)
- Change from Baseline in Urine Albumin-to-creatinine Ratio (uACR) at Week 72(Baseline and Week 72)
- Percent Change from Baseline at Week 72 in Fasting Concentration of Total Cholesterol(Baseline and Week 72)
- Percent Change from Baseline at Week 72 in Fasting Concentration of Non-high-density Lipoprotein Cholesterol (non-HDL-C)(Baseline and Week 72)
- Percent Change from Baseline at Week 72 in Fasting Concentration of Low-density Lipoprotein Cholesterol (LDL-C)(Baseline and Week 72)
- Percent Change from Baseline at Week 72 in Fasting Concentration of Very-low-density Lipoprotein Cholesterol (VLDL-C)(Baseline and Week 72)
- Percent Change from Baseline at Week 72 in Fasting Concentration of High-density Lipoprotein Cholesterol (HDL-C)(Baseline and Week 72)
- Change from Baseline in Diastolic Blood Pressure DBP at Week 72(Baseline and Week 72)
- Change from Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72(Baseline and Week 72)
- Number of Participants who Experienced Treatment-emergent Adverse Events(Up to Week 84)
- Number of Participants who Experienced Serious Adverse Events(Up to Week 84)
- Plasma Concentration of Maridebart Cafraglutide at Week 72(Week 72)
研究者
研究点 (184)
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