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
ovo Nordisk AS0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. 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
- •2. Male or female, age >= 18 years at the time of signing informed consent
- •3. 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
- •4. 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:
- •1. HbA1c >= 48 mmol/mol (6.5%) as measured by the central laboratory at screening
- •2. History of type 1 or type 2 diabetes mellitus
- •3. Treatment with glucose-lowering agent(s) within 90 days before screening
- •4. Treatment with a GLP-1 receptor agonist within 180 days before screening.
- •Obesity-related:
- •5. A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- •6. Treatment with any medication for the indication of obesity within the past 90 days before screening
- •7. 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
- •8. 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:
- •9. History of major depressive disorder within 2 years before screening
- •10. Diagnosis of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)
- •11. A Patient Health Questionnaire-9 (PHQ-9) score of >= 15 at screening
- •12. A lifetime history of a suicidal attempt
- •13. Suicidal behaviour within 30 days before screening
- •14. 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:
- •15. Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content within 90 days before screening
- •16. Presence of acute pancreatitis within the past 180 days prior to the day of screening
- •17. History or presence of chronic pancreatitis
- •18. Calcitonin >= 100 ng/L as measured by the central laboratory at screening
- •19. Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
- •20. 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
- •21. 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
- •22. Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina or transient ischaemic attack within the past 60 days prior to screening
- •23. Subject presently classified as being in New York Heart Association (NYHA) Class IV
- •24. Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator
- •25. Known or suspected abuse of alcohol or recreational drugs
- •26. Known or suspected hypersensitivity to trial product(s) or related products
- •27. Previous participation in this trial. Participation is defined as signed informed consent
- •28. Participation in another clinical trial within 90 days before screening <b
研究者
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