EUCTR2021-000138-33-ES进行中（未招募）1 期
A Randomized Double-Blind Placebo-Controlled Study of the LEPR Agonist Antibody REGN4461 for the Treatment of Metabolic Abnormalities in Patients with Familial Partial Lipodystrophy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female, >/= 18 years of age at the screening visit.
- •2. Clinical diagnosis of familial partial lipodystrophy as defined in the protocol
- •3. Fasting leptin level <=20ng/ml, as determined during the screening period
- •4. Presence of significant metabolic abnormalities as defined in the protocol
- •5. Stable body weight within the 3 months prior to screening (no gain or loss of >5% current weight)
- •6. Stable diet during the past 3 months defined as no major change in macronutrient composition (eg, starting or stopping diets such as Adkins, Paleo, Vegetarianism, Veganism).
- •7. No clinically meaningful change in medication regimen in the 3 months prior to screening as defined in the protocol
- •NOTE: Other protocol defined inclusion criteria apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1. Treatment with metreleptin within 3 months of the screening visit
- •2. Patients with a diagnosis of generalized lipodystrophy
- •3. Patients with a diagnosis of acquired lipodystrophy
- •4. Pregnant or breastfeeding women
- •NOTE: Other protocol defined exclusion criteria apply
研究者
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