The Effect of Semaglutide on Pituitary Function
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Growth hormone peak
研究概览
简要总结
The primary aim of the study is to describe the effect of a single oral dose of semaglutide 7 mg on growth hormone secretion.
详细描述
The randomized blinded placebo-controlled clinical trial is conducted on 10 healthy volunteers.
5 study subjects receive once 7 mg of oral semaglutide and once placebo. 5 study subjects receive once 14 mg of oral semaglutide and once placebo. The study group and order of administration of study medication are decided on randomization. The placebo and oral semaglutide are administered at least 4 weeks apart.
Blood samples are taken before and during 4 hours after the study medication administration (at 60, 90, 120, 150, 180, and 240 minutes after study medication administration).
The primary endpoint is the peak value of growth hormone measured during the 4 hours after study medication administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-50 years
- •The body weight >65 kg
排除标准
- •presence of chronic illness
- •the daily use of medications
- •pregnancy
- •lactation.
研究组 & 干预措施
Placebo
The placebo tablet taken orally with 120 ml of water.
干预措施: Placebo (Drug)
Oral semaglutide 7 mg
The semaglutide 7 mg tablet taken orally with upto120 ml of water.
干预措施: Semaglutide 7 MG Oral Tablet (Drug)
Oral semaglutide 14 mg
The semaglutide 14 mg tablet taken with upto 120 ml of water.
干预措施: Semaglutide 14 MG Oral Tablet (Drug)
结局指标
主要结局
Growth hormone peak
时间窗: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
Maximum concentration measured after study medication administration.
次要结局
- Adrenocorticotropin (ACTH) peak(60, 90, 120, 150, 180 and 240 minutes after study medication administration)
- Glucose nadir(60, 90, 120, 150, 180 and 240 minutes after study medication administration)
- Cortisol peak(60, 90, 120, 150, 180 and 240 minutes after study medication administration)
- Copeptin peak(60, 90, 120, 150, 180 and 240 minutes after study medication administration)
- Aldosterone peak(60, 90, 120, 150, 180 and 240 minutes after study medication administration)
- C-peptide peak(60, 90, 120, 150, 180 and 240 minutes after study medication administration)
研究者
Vallo Volke
Professor
University of Tartu