Evaluating Anti-Obesity Medications 6 Months After Metabolic Surgery

Официальное название

A Randomized, Double-Blind, Placebo-Controlled, Single-Center Study of Efsubaglutide Alfa in Patients Remaining Obese 6 Months After Metabolic Surgery

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Efsubaglutide Alfa Injection
  Efsubaglutide Alfa was injected daily in the morning before meals Subcutaneous injection at a dose of 1 mg/week in the first two weeks, increased to 3 mg/week in week 3, increased to 6 mg/week in week 5, up to 9 mg/2 week in week 13.
• Поведенческое Diet and exercise guidelines
  Participants followed a science-based diet and exercise program intervention.

Первичные конечные точки

• Change in %TWL from baseline to endpoint [Срок оценки: 24 weeks from enrollment]

Вторичные конечные точки (7)

• Proportion of patients with different %TWL levels [Срок оценки: 24 weeks from enrollment]
• Proportion of patients with normal weight and overweight [Срок оценки: 24 weeks from enrollment]
• Change in body composition from baseline to endpoint across patient groups [Срок оценки: 24 weeks from enrollment]
• Remission Status of Obesity-Related Diseases [Срок оценки: 24 weeks from enrollment]
• Changes in blood pressure from baseline to endpoint [Срок оценки: 24 weeks from enrollment]
• Changes in fasting blood glucose from baseline to endpoint [Срок оценки: 24 weeks from enrollment]
• Change in HbA1c from baseline to endpoint across patient groups [Срок оценки: 24 weeks from enrollment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Nanjing Drum Tower Hospital — Нанкин

Идентификаторы

NCT: NCT07163650 · 2025-0631-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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