NCT05073835进行中（未招募）3 期
BARI-STEP:A Double-blinded, Randomised, Placebo-controlled Trial of Semaglutide 2.4 mg in Patients With Poor Weight-loss Following Bariatric Surgery.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Weight loss
研究概览
简要总结
A double-blinded, randomised, placebo-controlled trial of semaglutide 3.0 mg/ml in patients with poor weight-loss following bariatric surgery. The primary aim of this trial is to determine whether, and the extent to which, 68 weeks of subcutaneous semaglutide 3.0 mg/ml causes greater percentage weight loss (%WL), reduction in adiposity, improvement in metabolic and inflammatory indices and health-related quality of life (HRQoL) than placebo, in patients with poor weight loss following gastric bypass or sleeve gastrectomy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
double blinded: both participants and study doctors will be blind to group allocation
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, ≥1 year primary GB or primary SG, with poor weight-loss (<20% WL) that is not caused by either a surgical or psychological problem.
- •Adults, 18-65 years inclusive.
- •Females of childbearing potential and female partners of male participants must be willing to use highly effective method of contraception (hormonal or barrier method of birth control; abstinence) (Appendix 2) from the time consent is signed until 2 months after treatment discontinuation.
- •Females of childbearing potential must have a negative pregnancy test within 7 days prior to randomisation. NOTE: Subjects are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
- •A self-reported ≤5 % variation in body weight over preceding 3 months.
- •Fluent in English and able to understand and complete questionnaires.
- •Participants capable to provide written informed consent and comply with the trial protocol.
排除标准
- •Bariatric surgical procedure other than GB and SG, or revision bariatric surgery of any operation type.
- •Personal history of type I diabetes or type II diabetes mellitus currently treated with insulin.
- •Concomitant use of GLP-1R agonist or DPPIV-inhibitors.
- •Female who is pregnant, breast-feeding, or intends to become pregnant.
- •Current participation in other clinical intervention trial.
- •History of suicidal attempt in the previous 5 years or untreated severe depression or mental health condition assessed by direct questioning.
- •Symptomatic gallstone disease
- •Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
- •Renal impairment measured as glomerular infiltration rate (eGFR <15 ml/min 1.73 m2
- •Known or suspected hypersensitivity to semaglutide or any of the excipients involved in their formulation.
- •Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type
- •History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.
- •Personal history of acute pancreatitis 180 days before screening or chronic pancreatitis.
- •Uncontrolled thyroid disease.
- •History of stroke, unstable angina, acute coronary syndrome, congestive heart failure New York Heart Association class III-IV within the preceding 12 months.
- •Untreated clinically significant arrhythmias.
- •Diabetic gastroparesis.
- •Concomitant usage of medications that cause weight gain or weight loss.
- •Known or suspected abuse of alcohol or recreational drugs.
- •Severe hepatic impairment diagnosed via liver function blood tests and clinical evaluation
- •Any additional factor, which in the investigator's opinion, might jeopardise the subject's safety or compliance with the trial protocol.
研究组 & 干预措施
Intervention
Experimental
Semaglutide 2.4mg/week subcutaneous injection for 68 weeks. The treatment includes an initial 16-week escalation phase followed by 52 weeks of treatment at study dose, i.e., 2.4mg/week.
干预措施: Semaglutide 3 mg (Drug)
Control
Placebo Comparator
Placebo administration, once weekly, subcutaneous injection.
干预措施: Placebo (Drug)
结局指标
主要结局
Weight loss
时间窗: 68 weeks
Percentage of total weight loss
次要结局
- Change in circulating HbA1c levels in participants with T2D at baseline(68 weeks)
- body weight reduction ≥10%(68 weeks)
- body weight reduction ≥15%(68 weeks)
- Change in circulating lipids(68 weeks)
- Change in circulating HsCRP and inflammatory cytokines(68 weeks)
- body weight reduction ≥20%(68 weeks)
- Change in circulating HbA1c levels in participants with pre-diabetes at baseline(68 weeks)
- Systolic and diastolic BP(68 weeks)
- pharmacological agents required for the management of hypertension(68 weeks)
- Change in circulating HbA1c levels(68 weeks)
- GLP-1 levels(68 weeks)
- Systolic and diastolic BP in participants with pre-existing hypertension(68 weeks)
- Changes in food craving scores assessed through power of food questionnaire(68 weeks)
- Changes in HRQoL(68 weeks)
研究者
研究点 (1)
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