NCT06041841尚未招募2 期
A Phase 2, Single-arm, Open-label Study to Assess Efficacy and Safety of LB54640 in Patients With Obesity Due to POMC, PCSK1, or LEPR Deficiency.
LG Chem2 个研究点 分布在 2 个国家目标入组 4 人开始时间: 2023年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Change of BMI
研究概览
简要总结
The purpose of the study was to assess the efficacy of LB54640 in participants with rare genetic disorders of obesity
详细描述
Patients with obesity due to POMC, PCSK1 or LEPR deficiency will be enrolled to receive LB54640 by oral administration for 16 weeks. After 16 weeks of treatment, the participant may enter a long term extension phase and receive treatment for up to 1 year.
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
- •Participants aged ≥12 years at the time of enrollment and diagnosed with genetic obesity due to POMC, PCSK1, or LEPR deficiency mutations.
- •Obesity is defined as BMI ≥30 kg/m2 for participants ≥18 years of age or BMI ≥95th percentile for age and gender for participants <18 years of age.
排除标准
- •Participants with recent (within 2 months, prior to Screening and up to enrollment) intensive diet/exercise regimen that resulted in >2% weight loss, use of medication to treat obesity (within 3 months of first dose of LB54640 with certain exceptions), or weight loss surgery within 6 months prior to Screening or prior surgery which resulted in >10% weight loss with no evidence of weight regain are excluded
- •History of major surgical procedure
- •Weight loss surgery within the previous 6 months
- •Any history of a suicide attempt, or any suicidal behavior
- •HbA1c >10.9%
- •Fasting glucose level >270 mg/dL
研究组 & 干预措施
POMC/PCSK1/LEPR cohort
Experimental
LB54640 once daily by oral administration
干预措施: LB54640 (Drug)
结局指标
主要结局
Change of BMI
时间窗: From baseline to Week 16
次要结局
- Frequency and severity of adverse events (AE)(From first dose up to Week 52)
- Mean change and mean percentage change from baseline in body weight(From baseline up to Week 52)
- Mean change and mean percentage change from baseline in body composition assessed by dual energy x-ray absorptiometry(From baseline up to Week 52)
- Frequency and severity of adverse events of special interest (AESI)(From first dose up to Week 52)
- Mean change and mean percentage change from baseline in waist circumference.(From baseline up to Week 52)
- Mean change and mean percentage change from baseline in Hunger Questionnaire Scores(From baseline up to Week 52)
研究者
研究点 (2)
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