NL-OMON48225已完成2 期
A Phase 2b/3 study to evaluate the safety, tolerability, and effects of livoletide (AZP-531), an unacylated ghrelin analog, on food-related behaviors in patients with Prader-Willi syndrome - Millendo AZP531PWS Study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •- A confirmed gentic diganosis of PWS. Documentation of PWS subtype. If PWS
- •subtype is not known, a sample for testing may be obtained
- •and the patient may continue on to be enrolled into the study if he/she meets
- •all the other inclusion criteria and non of the
- •exclusion criteria.
- •- Male and female patients 4 to 65 years of age.
- •- Evidence of increased appetite or hyperphagia, as jugded by the investigator
- •and HQ-CT score.
- •- Patient must have a single primary caregiver who should be available for the
- •duration of the study. On average,
- •approximately 4 (or more) waking hours per day with the patient.
- •- BMI * 65 kg/m2
- •- Growth hormone treatment permitted if doses are stable
排除标准
- •- History of chronic liver disease
- •- Type 1 diabetes mellitus
- •- HbA1c > 10%
研究者
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