A Randomized, Placebo-Controlled Trial of the Effects of Long-Acting GLP-1 or Dual Incretin (GLP-1 and GIP) Modulation on Gastric Motor Functions
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Gastric emptying of solids T1/2 min, that is time for half meal to empty from stomach
研究概览
简要总结
The purpose of this study is to compare effects of weekly SQ semaglutide 2.4mg SQ, SQ tirzepatide 10mg, and placebo administered for 24 weeks on GES measured repeatedly at baseline, 16 weeks, 24 weeks, 28 weeks, 4 weeks after stopping the medication, and accommodation and satiation at 24 weeks compared to baseline.
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)
盲法说明
Concealed allocation with masking of medications administered by subcutaneous injection once per week; blinding of all investigators since medication is dispensed by research pharmacy not by clinical research trials unit
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
semaglutide
Administered by subcutaneous injection once per week in accordance with FDA approved escalation as well as maintenance treatment
干预措施: Semaglutide (Drug)
Tirzepatide
Administered by subcutaneous injection once per week in accordance with FDA approved escalation as well as maintenance treatment
干预措施: Tirzepatide (Drug)
placebo
Administered by subcutaneous injection once per week
干预措施: Placebo (Drug)
结局指标
主要结局
Gastric emptying of solids T1/2 min, that is time for half meal to empty from stomach
时间窗: Measurement at baseline, after 16 and 24 weeks' treatment, and at 28 weeks (off treatment for 4 weeks)
Gastric emptying of an egg meal measured by scintigraphy
Body weight
时间窗: Measurement at baseline, after 16 and 24 weeks' treatment, and at 28 weeks (off treatment for 4 weeks)
Measurement of body weight using weight scales
次要结局
- Calories to fullness, kilocalories (kcal)(Measurement at baseline, and after 24 weeks' treatment)
- Maximum tolerated calories, kilocalories (kcal)(Measurement at baseline, and after 24 weeks' treatment)
- Fasting gastric volume, milliliters (mL)(Measurement at baseline, and after 24 weeks' treatment)
- Gastric accommodation vol (postprandial minus fasting volume), milliliters (mL)(Measurement at baseline, and after 24 weeks' treatment)
- Peak postprandial GLP-1 (glucagon-like peptide-1) pmol/L(Measurement at baseline, and after 24 weeks' treatment)
- Peak postprandial peptide tyrosine tyrosine (PYY) pmol/L(Measurement at baseline, and after 24 weeks' treatment)
- DEXA (dual energy X-ray absorptiometry) body composition(Measurement at baseline, and after 24 weeks' treatment)
研究者
Michael Camilleri, MD
Principal Investigator
Mayo Clinic