A Phase 2, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of NGM120 in Participants With Colorectal Cancer Who Have Cancer Cachexia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Change from baseline in body weight at Week 12
研究概览
简要总结
A multi-center evaluation of NGM120 in a randomized, double-blind, placebo-controlled study in participants with colorectal cancer who have cancer cachexia.
详细描述
Evaluation of Efficacy, Safety and Tolerability of NGM120 in a Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Participants with Colorectal Cancer who have Cancer Cachexia
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
- •Documented active diagnosis of colorectal cancer.
- •Cachexia defined by Fearon criteria of weight loss.
- •Signed informed consent.
排除标准
- •Current active reversible causes of decreased food intake.
- •Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization.
- •Have cachexia caused by other reasons.
研究组 & 干预措施
NGM120 Treatment Group A
NGM120 low dose given subcutaneously every 4 weeks
干预措施: NGM120 Q4W (Drug)
NGM120 Treatment Group B
Placebo low dose given subcutaneously every 4 weeks
干预措施: Placebo given (Drug)
NGM120 Treatment Group C
NGM120 high dose given subcutaneously every 4 weeks
干预措施: NGM120 Q4W (Drug)
NGM120 Treatment Group D
NGM120 high dose given subcutaneously every 8 weeks
干预措施: NGM120 Q8W (Drug)
NGM120 Treatment Group E
Placebo high dose given subcutaneously every 4 weeks
干预措施: Placebo given (Drug)
结局指标
主要结局
Change from baseline in body weight at Week 12
时间窗: 12 Weeks
To evaluate the effect of NGM120 compared to placebo on body weight.
Treatment-emergent adverse events (TEAEs) characterized by type, frequency, severity, timing, seriousness, and relationship to study drug
时间窗: 44 Weeks
To evaluate safety and tolerability of NGM120
次要结局
未报告次要终点