A Multicenter, Double-blind, Randomized, Placebo-controlled Extension Study Assessing the Efficacy and Long-term Safety of a 2 mg Dose of TH9507, a GHRH Analog, in HIV Subjects With Excess Abdominal Fat Accumulation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 263
- 试验地点
- 47
- 主要终点
- Changes From Baseline in Fasting Blood Glucose at Week 52
研究概览
简要总结
Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation
详细描述
HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation, loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from the first Phase 3 multicenter, randomized, placebo-controlled trial demonstrated that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV- infected patients with excess of abdominal fat accumulation for 26 weeks resulted in decreases in visceral adipose tissue (VAT) and trunk fat, with lesser changes in limb fat and subcutaneous adipose tissue (SAT). The present study is aimed at confirming the observations made during the first Phase 3 study.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have completed the 26 weeks treatment period of the TH9507-CTR-1011 study.
- •Signed informed consent before any trial-related activities.
排除标准
- •Fasting blood glucose >8.33 mmoL (150 mg/dL) at the end of the TH9507-CTR-1011 study.
研究组 & 干预措施
Tesamorelin 12 months (T-T)
Tesamorelin 2 mg/day for 12 months
干预措施: Tesamorelin (Drug)
Tesamorelin-Placebo (T-P)
Tesamorelin 2 mg/day for 6 months - Placebo for 6 months
干预措施: Tesamorelin (Drug)
Tesamorelin-Placebo (T-P)
Tesamorelin 2 mg/day for 6 months - Placebo for 6 months
干预措施: Placebo for Tesamorelin (Drug)
Placebo-Tesamorelin (P-T)
Placebo 6 months - Tesamorelin 2 mg/day for 6 months
干预措施: Tesamorelin (Drug)
Placebo-Tesamorelin (P-T)
Placebo 6 months - Tesamorelin 2 mg/day for 6 months
干预措施: Placebo for Tesamorelin (Drug)
结局指标
主要结局
Changes From Baseline in Fasting Blood Glucose at Week 52
时间窗: Baseline and Week 52
Blood glucose was determined after an overnight fast. Changes in blood glucose between baseline and Week 52 are reported.
Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52
时间窗: Baseline and Week 52
Glucose tolerance was determined after an overnight fast using standard 75 gram-oral glucose tolerance test (OGTT) with glucose measured at timepoints 0, 30, 60, 90 and 120. Changes in glucose tolerance between baseline and Week 52 are reported.
次要结局
- Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52(Baseline and Week 52)