EUCTR2024-000081-22-Outside-EU/EEA进行中（未招募）1 期
A Safety, Tolerability and Pharmacokinetic Study of Tirzepatide for the Treatment of Pediatric Participants (6 years to 11 years) with Obesity. - A Study of Tirzepatide (LY3298176) in Pediatric Participants With Obesity
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- 性别
- All
入选标准
- •Male and female participants with body mass index (BMI) = the 95th percentile for age and sex
- •Have failed to achieve adequate weight loss through lifestyle modification in the investigator's opinion
- •Female participants only: Determined as prepubertal Tanner Stage 1.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- •Have obesity induced by other endocrinologic disorders (for example, Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity
- •Have acute or chronic pancreatitis or a history of acute idiopathic pancreatitis; or have other GI disorders
- •Have a known clinically significant gastric emptying, have undergone weight loss surgery such as gastric bypass (bariatric) surgery or restrictive bariatric surger, or have endoscopic or device-based therapy for obesity or have had device removal within the last 6 months.
- •Have confirmed type 1 or type 2 diabetes mellitus
- •Have a history or current cerebrovascular, respiratory, hepatic, renal, GI, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the IP; or may interfere with the interpretation of data
研究者
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