NCT05322096已完成2 期
A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 23
- 主要终点
- There are no Primary Outcome Measures
研究概览
简要总结
RGH-706 is a novel, potent, and orally active MCHR1 antagonist drug candidate discovered and being developed by Gedeon Richter Plc. for weight management.
This will be the first Phase 2, proof-of-concept study using RGH-706 and is the third study in the clinical development program for RGH-706. The aim of this study is to evaluate the efficacy, safety, and tolerability of RGH-706 in patients with Prader-Willi Syndrome (PWS).
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
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged ≥17 years in USA at screening or aged ≥18 years in EU at screening
- •Genetically confirmed diagnosis of PWS
- •HQ-CT total score ≥14 at screening
- •Body weight ≥40 kg/88 lbs and ≤200 kg/450 lbs
- •Stable body weight
- •Negative pregnancy test for females of childbearing potential and nonlactating at screening.
- •Patients must be able to provide or have a parent or guardian who is able to provide written informed consent and/or assent (as applicable)
- •Patients must have at least 1 consistent and reliable primary caregiver
排除标准
- •Severe psychiatric disorders (eg, schizophrenia, bipolar disorder, or major depressive disorder), recent (within 6 months)
- •Risk of suicide according to the investigator's judgment
- •Uncontrollable diabetes mellitus or diabetes mellitus requiring insulin administration
- •Poorly controlled hypothyroidism or hyperthyroidism
- •Chronic or acute liver disease
- •History of bariatric surgery procedure
- •Uncontrolled obstructive sleep apnea.
- •History of malignancy within 5 years of screening
- •Systolic blood pressure (BP) ≥160 mmHg and/or diastolic BP ≥100 mmHg, pulse rate ≥100/min at screening.
- •Use of weight-lowering pharmacotherapy within 6 months prior to screening.
- •Known QT prolongation
- •Clinically relevant laboratory abnormalities
- •Any other condition that, in the investigator's opinion, might indicate that the patient is unsuitable for the study
研究组 & 干预措施
RGH-706
Experimental
Dose A once daily for 6 weeks
干预措施: RGH-706 (Drug)
Placebo
Placebo Comparator
Placebo once daily for 6 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
There are no Primary Outcome Measures
时间窗: There are no Primary Outcome Measures
次要结局
未报告次要终点
研究者
研究点 (23)
Loading locations...
相似试验
已完成
1 期
Effect of GSK1160724 In Healthy VolunteersPulmonary Disease, Chronic ObstructiveNCT00555022GlaxoSmithKline21
已完成
1 期
A Study To Assess The Pharmacokinetics Of SB-742457 Formulated As A Capsule And A Tablet In Healthy Elderly Volunteers.Alzheimer's DiseaseNCT00551772GlaxoSmithKline12
已完成
1 期
Effect of GSK704838 In Healthy VolunteersPulmonary Disease, Chronic ObstructiveNCT00539825GlaxoSmithKline20
已完成
2 期
Safety Study Using GSK573719 And Tiotropium In Patients With Chronic Obstructive Pulmonary DiseasePulmonary Disease, Chronic ObstructiveNCT00515502GlaxoSmithKline24
已完成
1 期
A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK573719 In Healthy VolunteersPulmonary Disease, Chronic ObstructiveNCT00475436GlaxoSmithKline36