A Randomized, Double-Blind, Placebo-Controlled, Single-Center Study of Efsubaglutide Alfa in Patients Remaining Obese 6 Months After Metabolic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in %TWL from baseline to endpoint
研究概览
简要总结
This clinical trial aims to evaluate the weight-loss efficacy and safety of efsubaglutide alfa in patients who remain obese 6 months after metabolic surgery.
详细描述
This study investigates the effects of efsubaglutide alfa intervention in patients with a body mass index (BMI) ≥28 kg/m² six months after metabolic surgery, aiming to determine whether it facilitates weight normalization and remission of obesity-related comorbidities, thereby assessing the weight-loss and metabolic benefits of early efsubaglutide alfa application in post-metabolic surgery obesity management.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6 months after metabolic surgery
- •18 years ≤ age ≤ 55 years
- •Body Mass Index (BMI) ≥ 28 kg/m^2
- •Voluntarily sign the informed consent form and agree to strictly adhere to the requirements and restrictions outlined in the informed consent form and this protocol throughout the entire study period.
排除标准
- •Subjects suspected by the investigator of having a potential allergy to the study drug or its components, or those with a history of allergic constitution;
- •Use of any of the following drugs or treatments prior to screening:
- •● Glucagon-like peptide-1 (GLP-1R) agonists within 3 months prior to screening
- •● Use within 3 months prior to screening of any weight-affecting medications, including systemic corticosteroids, metformin, sodium-glucose cotransporter 2 (SGLT2) inhibitors, etc.;
- •● Use of weight-affecting herbal supplements, health products, or meal replacements within 3 months prior to screening;
- •Use of weight-loss medications within 3 months prior to screening or currently using such medications, e.g., sibutramine hydrochloride, orlistat, phentermine, etc.;
- •Participation in other clinical trials (receiving investigational drug treatment) within 3 months prior to screening.
- •③ History or evidence of any of the following conditions prior to screening:
- •History of depression; or history of severe psychiatric disorders such as schizophrenia, bipolar disorder, etc.;
- •Uncontrolled hypertension at screening despite at least 4 weeks of antihypertensive medication, defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg;
- •History of malignancy at screening;
- •History of cardiac disease at screening: acute myocardial infarction, unstable angina, post-coronary artery bypass grafting, post-percutaneous coronary intervention, severe arrhythmia;
- •Hemorrhagic or ischemic stroke, or transient ischemic attack within 6 months prior to screening;
- •History or family history of medullary thyroid carcinoma, multiple endocrine neoplasia (MEN) type 2A or 2B at screening;
- •History of acute or chronic pancreatitis, or pancreatic injury at screening;
- •Presence of limb deformities or amputations preventing accurate measurement of height, weight, or other anthropometric parameters;
- •Major or moderate surgery, severe trauma, or severe infection within 1 month prior to screening, deemed unsuitable for study participation by the investigator;
- •History of suicidal tendencies or suicide attempts;
- •Anticipated surgery during the study period;
- •Participants testing positive for HIV antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or syphilis antibodies at screening;
- •History of alcohol abuse within 1 month prior to screening, defined as average weekly alcohol intake exceeding 21 units for males or 14 units for females; ④ Presents clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening: - Second- or third-degree atrioventricular block - Long QT syndrome or QTcF > 450 ms - PR interval < 120 ms or PR interval > 220 ms - QRS > 120 ms QRS duration >120ms, left or right bundle branch block, Wolff-Parkinson-White syndrome, or other severe arrhythmias requiring treatment;
- •History of other risk factors for torsades de pointes, such as hypokalemia at screening, family history of long QT syndrome, or concomitant use of QT/QTc-prolonging medications at screening; ⑥ Blood donation volume and/or blood loss ≥400 mL within 3 months prior to screening, or hemoglobin <110 g/L (males) or <100 g/L (females); ⑦ Presence of any other factors deemed by the investigator to potentially affect the efficacy or safety evaluation of this study, rendering the subject unsuitable for participation.
研究组 & 干预措施
Efsubaglutide Alfa group
Receive guidance on diet and exercise throughout the program, started pharmacological intervention at enrollment for 24 weeks.
干预措施: Efsubaglutide Alfa Injection (Drug)
Efsubaglutide Alfa group
Receive guidance on diet and exercise throughout the program, started pharmacological intervention at enrollment for 24 weeks.
干预措施: Diet and exercise guidelines (Behavioral)
control group
Receive guidance on diet and exercise throughout the program, without the use of drugs.
干预措施: Diet and exercise guidelines (Behavioral)
结局指标
主要结局
Change in %TWL from baseline to endpoint
时间窗: 24 weeks from enrollment
%TWL = (\[baseline weight - weight at follow-up\]/baseline weight) × 100%. The measurement of body weight is in kilograms. %TWL represents the percentage of total weight loss, measured in percent. This indicator reflects the percentage of weight loss from the baseline. The mean and standard deviation of %TWL were calculated for subjects within each group. Subsequently, intergroup comparisons were performed to calculate p-values. If p \< 0.05, pairwise comparisons were further conducted. Based on the final results, the differences in weight loss among groups were evaluated.
次要结局
- Proportion of patients with different %TWL levels(24 weeks from enrollment)
- Proportion of patients with normal weight and overweight(24 weeks from enrollment)
- Remission Status of Obesity-Related Diseases(24 weeks from enrollment)
- Change in body composition from baseline to endpoint across patient groups(24 weeks from enrollment)
- Changes in blood pressure from baseline to endpoint(24 weeks from enrollment)
- Changes in fasting blood glucose from baseline to endpoint(24 weeks from enrollment)
- Change in HbA1c from baseline to endpoint across patient groups(24 weeks from enrollment)