NCT06596135已完成3 期
Open-Label Extension Study of Setmelanotide in Patients With a Rare Genetic, Syndromic or Acquired Disease of the MC4R Pathway
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 26
- 主要终点
- Safety and tolerability of setmelanotide assessed by frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This is an open-label extension study designed to evaluate the long-term safety and tolerability of continued setmelanotide treatment in male and female patients ≥2 years of age who have completed or transitioned from a previous study with setmelanotide for rare genetic, syndromic, or acquired diseases of obesity upstream of the MC4R pathway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ≥2 years of age who have completed a previous setmelanotide clinical study and who have a condition or indication for which Rhythm plans further clinical development.
- •Agree to use a highly effective form of contraception and follow the study contraception requirements throughout study duration and for 90 days after.
- •Demonstrated clinical benefit in the previous setmelanotide study, as determined by the Investigator.
排除标准
- •Any gene variant, syndromic, or acquired disease for which setmelanotide is currently approved in the United States (i.e., patients eligible for commercial setmelanotide (IMCIVREE®).
- •Any new or worsening depression resulting in suicidal thoughts and/or behaviors.
- •Discontinuation from a previous setmelanotide study.
- •History or close family history (parents or siblings) of melanoma.
- •Pregnant and/or breastfeeding women
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Setelanotide (Open-label)
Experimental
Once daily (QD) subcutaneous injection of setmelanotide
干预措施: Setmelanotide (Drug)
结局指标
主要结局
Safety and tolerability of setmelanotide assessed by frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Up to 3 years
次要结局
未报告次要终点
研究者
研究点 (26)
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