NCT07156578Enrolling By Invitation2 期
A Long-Term, Open-Label Extension Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 25
- 试验地点
- 9
- 主要终点
- Safety and tolerability of bivamelagon as assessed by the number and frequency of AEs
研究概览
简要总结
This is a long-term, open-label extension study of bivamelagon in participants with Hypothalamic Obesity (HO) who have transitioned from the index study, LG-MCCL005. The study will last up to 2 years.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed LG-MCCL005 and participant demonstrated adequate safety and tolerability in that study as determined by the Investigator.
- •Agree to use a highly effective form of contraception and follow contraception requirements throughout the study and for 90 days after.
排除标准
- •Willing to remain off of: CYP3A4 inhibitors, strong CYP3A4 inducers, and P-glycoprotein inhibitors or substrates for the duration of the study.
- •In the opinion of the Investigator, participant is not suitable to participate in the study.
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Bivamelagon (open-label)
Experimental
干预措施: Bivamelagon (Drug)
结局指标
主要结局
Safety and tolerability of bivamelagon as assessed by the number and frequency of AEs
时间窗: Baseline to up to 2 years
次要结局
- Mean change in BMI z-score in participants >18 years of age.(Baseline to up to 2 years)
- Mean change and mean percentage change from Baseline in BMI in participants ≥18 years of age.(Baseline to up to 2 years)
- Percentage of patients who achieve ≥5%,≥10%, ≥15%, and ≥20% reduction in BMI from baseline(Baseline to up to 2 years)
- Mean change in and mean percentage change in weight(Baseline to up to 2 years)
- Mean change in percentage of the 95th percentile of BMI in participants <18 years of age.(Baseline to up to 2 years)
- Mean change from Baseline in Physical function (and total score) for the Impact of Weight on Quality of Life-Lite (IWQoL) in participants ≥18 years of age(Baseline to up to 2 years)
- Change from Baseline in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides(Baseline to up 2 years)
研究者
研究点 (9)
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