Achieving Sustained Weight Control Via Exercise, Nutrition & Drugs (Mazdutide) (ASCEND- 1 Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 420
- 试验地点
- 13
- 主要终点
- Percentage change of body weight
研究概览
简要总结
Obesity is a chronic, progressive, and relapsing disease. Although lifestyle interventions and anti-obesity medications are effective for inducing weight loss, evidence regarding their role in long-term weight maintenance after pharmacologically induced weight reduction remains limited. In addition, the high cost and potential adverse effects of weight-loss medications restrict their prolonged use, and it is unclear whether low dose medication, intensive life style intervention or together can serve as an effective strategy for weight maintenance.
This randomized controlled trial aims to evaluate the effectiveness of a 1-year intensive lifestyle intervention, a reduced dose of mazdutide (3.0 mg once weekly), or their combination in weight maintenance among individuals with obesity who have achieved initial weight loss after intensive treatment with high dose mazdutide. The study seeks to provide high-quality clinical evidence to inform long-term weight maintenance strategies after weight loss in patients with obesity.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men or women aged 18 years or older;
- •Simple obesity, defined as a body mass index (BMI) of 28.0-45.0 kg/m²;
- •Able and willing to provide written informed consent.
排除标准
- •Active pulmonary tuberculosis, malignant tumors, human immunodeficiency virus (HIV) infection, or other serious infectious or systemic diseases;
- •Severe hepatic impairment (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >3 times the upper limit of normal), severe renal impairment, or end-stage renal disease (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m²);
- •Severe cardiovascular diseases, including angina pectoris, myocardial infarction, or stroke within the past 6 months;
- •Severe gastrointestinal diseases, or a history of gastrointestinal resection surgery within the past year;
- •Acute or chronic pancreatitis, gallbladder disease, or pancreatic injury;
- •Obesity secondary to other causes, including Cushing's syndrome, primary hypothyroidism, hypothalamic obesity, or acromegaly; drug-induced obesity, such as obesity related to the use of antipsychotic agents or glucocorticoids;
- •Current smoker or habitual smoking within the past 3 months;
- •Current use of other weight-loss medications or a history of bariatric surgery;
- •Previously diagnosed diabetes mellitus or current use of glucose-lowering medications;
- •Pregnant or breastfeeding women, or women planning pregnancy during the study period;
- •Inability to complete a 2-year follow-up due to health conditions, relocation, or other reasons;
- •Any other condition deemed by the investigator to make the participant unsuitable for participation in the study.
研究组 & 干预措施
Mazdutide Plus Intensive Lifestyle Intervention
After 16-week intensive treatment with mazdutide, participants are randomized into four different arms. In this arm, participants receive mazdutide 3.0 mg once weekly plus intensive lifestyle intervention for 52 weeks during the weight maintenance period.
干预措施: Intensive Lifestyle Intervention (Behavioral)
Placebo plus Intensive Lifestyle Intervention
After 16-week intensive treatment with mazdutide, participants are randomized into four different arms. In this arm, participants receive placebo once weekly plus intensive lifestyle intervention for 52 weeks during the weight maintenance period.
干预措施: Intensive Lifestyle Intervention (Behavioral)
Mazdutide
After 16-week intensive treatment with mazdutide, participants are randomized into four different arms. In this arm, participants receive mazdutide 3.0 mg once weekly for 52 weeks during the weight maintenance period.
干预措施: Mazdutide (Drug)
Mazdutide Plus Intensive Lifestyle Intervention
After 16-week intensive treatment with mazdutide, participants are randomized into four different arms. In this arm, participants receive mazdutide 3.0 mg once weekly plus intensive lifestyle intervention for 52 weeks during the weight maintenance period.
干预措施: Mazdutide (Drug)
Standard Health Education (Control)
After 16-week intensive treatment with mazdutide, participants are randomized into four different arms. In this arm, participants receive standard health education only for 52 weeks during the weight maintenance period.
结局指标
主要结局
Percentage change of body weight
时间窗: From randomization to Week 52
次要结局
- Change in body mass index (BMI)(From randomization to Week 52)
- Change in waist circumference(From randomization to Week 52)
- Change in total body fat(From randomization to Week 52)
- Change in abdominal visceral fat area(From randomization to Week 52)
- Change in hepatic fat content(From randomization to Week 52)
- Change in blood pressure(From randomization to Week 52)
- Change in serum lipid profile(From randomization to Week 52)
- Changes in blood glucose(From randomization to Week 52)
- Changes in insulin sensitivity(From randomization to Week 52)
- Changes in pancreatic β-cell function(From randomization to Week 52)
- Change in pulse wave velocity (PWV)(From randomization to Week 52)
- Quality of sleep measured by the Pittsburgh sleep quality index (PSQI)(From randomization to Week 52)
- Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)(From randomization to Week 52)