NCT05164341进行中（未招募）3 期
A 12-Month Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With Partial Lipodystrophy
Amryt Pharma31 个研究点 分布在 9 个国家目标入组 69 人开始时间: 2021年12月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 69
- 试验地点
- 31
- 主要终点
- Percent change from Baseline to month 6 in fasting TGs in subjects with partial lipodystrophy (PL)
研究概览
简要总结
This is a Phase III, double-blind, placebo-controlled, safety and efficacy study of daily SC metreleptin in subjects with Partial Lipodystrophy.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Familial Partial Lipodystrophy (FPLD)
- •Subjects with poor metabolic control defined as:
- •HbA1c ≥7% (at Visit 1 and Visit 3) and/or Fasting TGs ≥500 mg/dL (5.65 mmol/L, at Visit 1 and Visit 3)
- •Patients should be receiving optimized stable therapy
排除标准
- •Previous treatment with metreleptin
- •Leptin levels >20.0 ng/mL
- •Acquired or radiation induced partial lipodystrophy (APL)
- •Other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
placebo
Placebo Comparator
Placebo for daily injection is a sterile, white, solid lyophilised cake
干预措施: Placebo (Drug)
metreleptin
Active Comparator
Metreleptin [Recombinant-methionyl human Leptin; r-metHuLeptin] for daily injection is a sterile, white, solid lyophilised cake
干预措施: metreleptin (Drug)
结局指标
主要结局
Percent change from Baseline to month 6 in fasting TGs in subjects with partial lipodystrophy (PL)
时间窗: 6 months
To evaluate the efficacy (TGs) of daily SC metreleptin treatment
Change from baseline to month 6 in HbA1c in subjects with partial lipodystrophy (PL)
时间窗: 6 months
To evaluate the efficacy (HbAa1c) of daily SC metreleptin treatment
次要结局
- Change from baseline to months 9 and 12 in HbA1c in subjects with partial lipodystrophy (PL)(12 months)
- Percent change from baseline to months 9 and 12 in fasting TGs in subjects with partial lipodystrophy (PL)(12 months)
- Safety analysis of AEs, AESIs, SAEs by treatment arm(12 months)
- Change from Baseline to each assessment time point in quality of life (QoL) in all subjects(12 months)
研究者
研究点 (31)
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