jRCT2041230156进行中（未招募）不适用
A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients with Acquired Hypothalamic Obesity
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 主要终点
- Mean % change in BMI from Baseline
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 4age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patient has documented evidence of acquired HO
- •Aged 4 years and older
- •Documented weight gain associated with the hypothalamic injury either, and a body mass index (BMI) of >-30 kg/m2 for patients >-18 years of age, or BMI>-95th percentile for age and sex for patients 4 to <18 years of age
- •A highly effective form of contraception must be used/practiced throughout the trial and for 90 days
- •If receiving hormone replacement therapy, the dose of such therapy has remained stable for at least 2 months prior to Screening
- •Other protocol defined Inclusion criteria may apply.
排除标准
- •Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET)
- •Weight loss >2% in the previous 3 months for patients aged >-18 years or >2% reduction in BMI for patients aged 4 to <18 years
- •Bariatric surgery or procedure within the last 2 years
- •Diagnosis of severe psychiatric disorders, or any suicidal ideation, attempts, or any suicidal
- •Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease considered
- •Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)
- •History or close family history of skin cancer or melanoma
- •Participation in any clinical trial with an investigational drug/device within 3 months, prior to the first trial dose
- •Previously enrolled in a clinical trial involving setmelanotide or any previous exposure to setmelanotide
- •Inability to comply with once daily (QD) injection regimen
- •Pregnant and/or breastfeeding
- •Patients with obesity attributable to other genetic or syndromic conditions (eg, PPL [POMC, PCSK1, LEPR, collectively], BBS) prior to the hypothalamic injury
- •Hypersensitivity to setmelanotide and/or any excipients contained in the investigational drug
- •Other protocol defined Exclusion criteria may apply.
结局指标
主要结局
Mean % change in BMI from Baseline
时间窗: after approximately 52 weeks
Mean percentage change in Body Mass Index (BMI) from baseline after treatment
次要结局
未报告次要终点
研究者
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