A Randomized, Placebo-controlled, Double-Blind Phase 2 Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity, With an Open-Label Extension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 10
- 主要终点
- Mean percentage change in BMI
研究概览
简要总结
The goal of this study is to determine how well LB54640 works and how safe it is in patients with Hypothalamic Obesity (HO). The study will evaluate the effect of LB54640 on safety, weight reduction, hunger, and quality of life in patients 12 years of age and older with HO. Patients will take an oral daily dose of either LB54640 (low, middle, or high dose) or placebo through Week 14. Eligible patients who consent to continue in the study after Week 14 will take an oral daily dose of LB54640 through Week 56.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Documented evidence of acquired hypothalamic obesity (HO)
- •Age 12 years and older
- •Weight gain associated with the hypothalamic injury and a BMI of ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th percentile for age and sex for patients <18 years of age
- •Male and female participants agree to follow study contraception requirements and use a highly effective form of contraception throughout the study and for 90 days after the study
排除标准
- •Weight loss >2% in the previous 3 months for patients ≥18 years of age or >2% reduction in BMI for patients <18 years of age
- •History of major surgical procedure within 30 days
- •HbA1c >10.9%
- •Fasting glucose level >270 mg/dL
- •Previous use of MC4R agonists
- •Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET).
- •Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior
- •History or close family history of skin cancer or melanoma
- •Current clinically significant pulmonary, cardiac, or oncologic disease considered severe enough to interfere with the study and/or confound the results
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
LB54640 Low dose
Participants will be randomized to receive LB54640 low dose, middle dose, or high dose, or placebo by oral administration in a 1:1:1:1 ratio.
干预措施: LB54640 (Drug)
LB54640 Middle dose
Participants will be randomized to receive LB54640 low dose, middle dose, or high dose, or placebo by oral administration in a 1:1:1:1 ratio.
干预措施: LB54640 (Drug)
LB54640 High dose
Participants will be randomized to receive LB54640 low dose, middle dose, or high dose, or placebo by oral administration in a 1:1:1:1 ratio.
干预措施: LB54640 (Drug)
Placebo
Participants will be randomized to receive LB54640 low dose, middle dose, or high dose, or placebo by oral administration in a 1:1:1:1 ratio.
干预措施: Placebo (Drug)
Open-label LB54640
Eligible participants who provide consent to continue into the open-label portion of the study will receive open-label LB54640.
干预措施: LB54640 (Drug)
结局指标
主要结局
Mean percentage change in BMI
时间窗: From Baseline to Week 14
次要结局
- Frequency and severity of adverse events (AEs)(From Baseline to Week 52)
- Mean change in BMI(Baseline to Weeks 6, 10, 14)
- Proportion of patients who achieve ≥5% reduction in body weight(Baseline to Week 14)
- Mean change in the weekly average of the daily most hunger score(Baseline to Week 14)
- Mean change and mean percentage change from baseline in body weight(From Baseline to Week 52)
- Mean change and mean percentage change from baseline in waist circumference.(From Baseline to Week 52)
- Mean change and mean percentage change from baseline in body composition assessed by dual energy x-ray absorptiometry(From Baseline to Week 52)