EUCTR2020-002479-37-SE进行中（未招募）1 期
A Phase II, randomized, double blind, parallel group,46 weeks dose-finding study of BI 456906 administered once weekly subcutaneously compared with placebo in patients with obesity or overweight - Combined PhIIa/b in Obesity
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Adult = 18 years and < 75 years of age at screening
- •2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- •3. Obesity or Overweight defined as BMI =27 kg/m2 at screening
- •4. A minimum absolute body weight of 70 kg for females and 80 kg for males at screening
- •5. Male or female participants. Women of childbearing potential (WOCBP)1 must be willing and able to use two forms of effective contraception where at least one form is highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
- •6. Patients must have undergone at least one previous unsuccessful nonsurgical weight-loss attempt per investigator’s judgement
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 162
排除标准
- •1. Body weight change of over +/- 5% or more in the past 12 weeks prior to randomization. There must be documentation of weight in the past 12 weeks before randomization.
- •2. Obesity induced by an endocrinologic disorder (e.g. Cushing Syndrome)
- •3. A HbA1c = 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus
- •4. Exposure to GLP-1Ra based therapies within three months prior to screening
- •5. Any suicidal behaviour in the past 2 years, any suicidal ideation of type 4 or 5 in the CSSRS within 3 months before screening, or during screening period
- •6. History of major depressive disorder within 2 years before randomization
- •7. Major depressive symptoms (defined as a screening Patient Health Questionnaire-9 [PHQ-9] score =15) at screening and/or during screening period
- •8. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders at screening
- •9. Screening calcitonin =20 pg/mL
- •10. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, manifest hypo- or hyperthyroidism at screening
- •11. History of chronic or acute pancreatitis or elevation of serum lipase/amylase > 2x ULN, or fasting serum triglyceride levels of > 500 mg/dl at screening
- •12. Treatment with medication that potentially induce a change in body weight (e.g., steroids, antipsychotics) , or anti-obesity medication including over-the-counter [OTC] medications, or participating in an organized weight loss program (e.g. Weight Watchers® or Noom® ) within 3 months before screening
- •13. Prior surgery of the GI tract that could interfere with body weight (including minimally invasive/endoscopic bariatric devices, bariatric surgery) except appendectomy and simple hernia repair before randomization
- •14. Resting Heart Rate >100 bpm at screening or randomisation
- •15. Systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 95 mmHg at screening
- •Further criteria apply.
研究者
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