A Phase 2b, Double-blind, Randomized, Placebo-controlled, Dose-finding, Multi-center, 36-week Safety and Efficacy Study With Open-label Extension (OLE) Period of Tesomet in Subjects With Hypothalamic Obesity
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Body weight (%)
研究概览
简要总结
This study will evaluate the safety and efficacy of Tesomet (tesofensine + metoprolol) in subjects 18 years of age or older, with HO
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject and, if applicable, their parent or legal guardian must be willing to provide informed consent
- •Diagnosis of HO secondary to damage to the hypothalamus
- •Female subjects must be of non-childbearing potential
- •At least 6 months since completion of therapy (chemotherapy, surgery, or radiation with resulting injury to the hypothalamus and/or the pituitary) with stable disease and lack of recurrence
- •BMI 30.0 to 60.0 kg/m², inclusive
- •Documented stable body weight (gain/loss <10%) for at least 90 days prior to Screening
- •Stable and well-managed pituitary replacement (eg, glucocorticoid, thyroid hormone, estrogen/progestin or testosterone, desmopressin, or growth hormone) for >2 months prior to Screening
- •Male subjects who are sexually active must be surgically sterile
排除标准
- •Females who are pregnant, breastfeeding, or actively intending to become pregnant during the study
- •Sitting BP that meets the following criteria after 5 minutes of rest at Screening:
- •Systolic BP >145 mmHg or <100 mmHg; or
- •Diastolic BP >95 mmHg or <70 mmHg
- •Type 1 diabetes mellitus
- •History of major depressive disorder within 2 years prior to Screening, or any history of other severe psychiatric disorder (eg, schizophrenia, bipolar disorder)
- •Uncontrolled endocrine disorders (eg, Cushing syndrome, Addison's, hypothyroidism, hyperthyroidism)
- •History of bulimia or anorexia nervosa
- •Use of prohibited medications, including current use of selective serotonin reuptake inhibitors / serotonin-norepinephrine reuptake inhibitors (SSRIs/SNRIs)
研究组 & 干预措施
Placebo
Once-daily PO for 36 weeks during the double-blind period; then if continued eligible for OLE, once-daily dosing for 36 weeks at the highest tolerated Tesomet dose from the double-blind period
干预措施: Placebo (Other)
Placebo
Once-daily PO for 36 weeks during the double-blind period; then if continued eligible for OLE, once-daily dosing for 36 weeks at the highest tolerated Tesomet dose from the double-blind period
干预措施: Tesomet (Drug)
Tesomet Low Dose
Once-daily PO for 36 weeks during the double-blind period; then if continued eligible for OLE, once-daily dosing for 36 weeks at the highest tolerated dose from the double-blind period
干预措施: Tesomet (Drug)
Tesomet Medium Dose
Once-daily PO for 36 weeks during the double-blind period; then if continued eligible for OLE, once-daily dosing for 36 weeks at the highest tolerated dose from the double-blind period
干预措施: Tesomet (Drug)
Tesomet High Dose
Once-daily PO for 36 weeks during the double-blind period; then if continued eligible for OLE, once-daily dosing for 36 weeks at the highest tolerated dose from the double-blind period
干预措施: Tesomet (Drug)
结局指标
主要结局
Body weight (%)
时间窗: Baseline to Week 36
Percentage change in body weight
次要结局
- Body weight loss(Week 36)
- Body weight (kg)(Baseline to Week 36)
- Waist circumference (cm)(Baseline to Week 36)
- Body Mass Index (BMI)(Baseline to Week 36)