jRCT2031250134尚未招募不适用
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Amgen K.K.
- 入组人数
- 272
- 主要终点
- Percent Change From Baseline in Body Weight at Week 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Age >= 18 years.
- •History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
- •Body mass index (BMI) >= 35 kg/m^2 at screening with a current diagnosis of at least 1 of the weigh-related comorbidities specified in the Japan Society for the Study of Obesity (JASSO) guideline OR BMI >= 27 kg/m^2 to < 35 kg/m^2 at screening, with a current diagnosis of at least 2 of the weight-related comorbidities specified in the JASSO guideline.
- •For both BMI categories, at least 1 of the weight-related comorbidities must be hypertension, dyslipidemia, or T2DM.
- •a. hypertension: treated, or with SBP >= 140 mmHg, or DBP >= 90 mmHg at screening.
- •b. dyslipidemia: treated, or with LDL > 140 mg/dL (3.6 mmol/L), or triglycerides >= 150 mg/dL (1.7 mmol/L), non-HDL cholesterol > 170 mg/dL (4.4 mmol/L) or HDL < 40 mg/dL (1.0 mmol/L) at screening.
- •c. T2DM: diagnosed >= 180 days before screening, and treated with diet and exercise alone and/or a stable treatment for at least 90 days before screening with up to 3 oral glucose-lowering medications (as per local labeling) (except for glucagon-like peptide-1 receptor agonists [GLP-1RA] and dipeptidyl peptidase-4 [DPP-4] inhibitors), and have a HbA1c >= 7% and <= 10% (53-86 mmol/mol) at screening.
- •In the opinion of the investigator, well-motivated and willing to:
- •a. Follow study procedures for the duration of the study, including, but not limited to, follow lifestyle advice, maintain a study log(s)/ diary(ies), and complete required study visits and questionnaires.
- •b. Perform self-monitoring blood glucose (SMBG) per protocol (only for participants with T2DM).
排除标准
- •Obesity induced by other endocrinological disorders or monogenetic or syndromic forms of obesity.
- •Self-reported change in body weight > 5 kg within 90 days before screening.
- •Previous or planned (during the study) surgical, endoscopic, or device based treatment for obesity.
- •For participants without diabetes at screening, type 1 or 2 diabetes mellitus or any other types of diabetes mellitus (except history of gestational diabetes).
- •For participants with T2DM at screening, any other type(s) of diabetes mellitus except T2DM.
- •History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
- •Family (first-degree relative[s]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2).
- •History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
- •Lifetime history of suicide attempt.
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
Percent change from baseline in body weight at Week 72
Participants Achieving >= 5% Reduction in Body Weight From Baseline at Week 72
时间窗: Baseline and Week 72
Participants achieving >= 5% reduction in body weight from baseline at Week 72
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian ParticipantsHealthy ParticipantsNCT05056246Amgen34
已完成
1 期
Single and Multiple Ascending Dose Study of AMG 133 in Participants With ObesityObesityNCT04478708Amgen110
进行中（未招募）
3 期
Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are OverweightObesityNCT06858839Amgen3,853
进行中（未招募）
3 期
Efficacy and Safety of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity DiseaseNCT06987695Amgen279
进行中（未招募）
3 期
Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are OverweightNCT06858878Amgen1,105