CTRI/2018/07/014765进行中（未招募）3 期
Effect and safety of semaglutide 2.4 mg once-weekly in subjects with overweight or obesity
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,950
- 试验地点
- 17
- 主要终点
- 1. Change from baseline at week 0 to week 68 in body weight (%)
研究概览
简要总结
This is a 68-week, randomised, double-blind, placebo-controlled, two-armed, parallel group, multi-centre, multinational clinical trial comparing semaglutide s.c. 2.4 mg once-weekly with semaglutide placebo once-weekly in subjects with overweight or obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Informed consent obtained before any trial-related activities.
- •Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- •Male or female, age ≥ 18 years at the time of signing informed consent
- •Body mass index (BMI) ≥ 30 kg/m2 or ≥ 27 kg/m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
- •History of at least one self-reported unsuccessful dietary effort to lose body weight.
排除标准
- •Subjects are excluded from the trial if any of the following criteria apply: Glycaemia-related:
- •HbA1c ≥ 48 mmol/mol (6.5%) as measured by the central laboratory at screening
- •History of type 1 or type 2 diabetes mellitus
- •Treatment with glucose-lowering agent(s) within 90 days before screening
- •Obesity-related:
- •A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- •Treatment with any medication for the indication of obesity within the past 90 days before screening
- •Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device.
- •However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed > 1 year before screening, (2) lap banding, if the band has been removed > 1 year before screening, (3) intragastric balloon, if the balloon has been removed > 1 year before screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening
- •Uncontrolled thyroid disease, defined as thyroid stimulating hormone (TSH) > 6.0 mIU/L or < 0.4 mIU/L as measured by the central laboratory at screening.
- •Mental health:
- •Diagnosis of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)
- •A Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at screening
- •A lifetime history of a suicidal attempt
- •Suicidal behaviour within 30 days before screening
- •Suicidal ideation corresponding to type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 30 days before screening.
- •General safety:
- •Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content within 90 days before screening
- •Presence of acute pancreatitis within the past 180 days prior to the day of screening
- •History or presence of chronic pancreatitis
- •Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
- •Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR < 15 ml/min/1.73 m2 as defined by KDIGO 201268 by the central laboratory at screening
- •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
- •Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina or transient ischaemic attack within the past 60 days prior to screening
- •Subject presently classified as being in New York Heart Association (NYHA) Class IV
- •Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator
- •Known or suspected abuse of alcohol or recreational drugs
- •Known or suspected hypersensitivity to trial product(s) or related products
- •Previous participation in this trial.
- •Participation is defined as signed informed consent
- •Other subject(s) from the same household participating in any semaglutide trial
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
- •Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator’s opinion, might jeopardise the subject’s safety or compliance with the protocol.
结局指标
主要结局
1. Change from baseline at week 0 to week 68 in body weight (%)
时间窗: 68 Weeks
2. Subjects who after 68 weeks achieve (yes/no):
时间窗: 68 Weeks
3. Body weight reduction ≥ 5% from baseline at week
时间窗: 68 Weeks
次要结局
- Subjects who after 68 weeks achieve(1.Body weight reduction ≥ 10% from baseline at week 0 (68 Weeks))
- Change from baseline at week 0 to week 68(1. Waist circumference (cm) (68 Weeks))
研究者
研究点 (17)
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