Effect of Semaglutide 2.4 mg Once-weekly on Gastric Emptying in Subjects With Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- AUC0-5h,para: the area under the paracetamol concentration-time curve from 0 to 5 hours at steady state
研究概览
简要总结
This study will look at how the emptying of the participant's stomach after a meal is affected by semaglutide (a new medicine) compared to a "dummy" medicine. In addition, the study will also look at the effect of semaglutide on the participant's appetite and energy intake. Participants will either get semaglutide or "dummy" medicine - which treatment any participant gets is decided by chance. Participants will take 1 injection per week. The study medicine is injected with a thin needle in the stomach, thigh or upper arm. The study will last for about 27 weeks (from first treatment to last check-up). Participants will have 8 visits at the clinic with the study doctor.
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
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
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
- •Male or female, aged between 18 to 65 years (both inclusive) at the time of signing informed consent
- •Body mass index (BMI) between 30.0 and 45.0 kg/m^2 (both inclusive)
- •Exclusion criteria:
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
- •Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
- •Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions
排除标准
- 未提供
研究组 & 干预措施
Semaglutide
Participants will receive increasing doses of semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks.
干预措施: Semaglutide (Drug)
Placebo (Semaglutide)
Participants will receive placebo (semaglutide). The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
AUC0-5h,para: the area under the paracetamol concentration-time curve from 0 to 5 hours at steady state
时间窗: 0 to 5 hours after standardised meal (day 142)
Measured in h\*micrograms/mL
次要结局
- AUC0-1h,para: the area under the paracetamol concentration-time curve from 0 to 1 hour at steady state(0 to 1 hour after standardised meal (day 142))
- Cmax,para: the maximum observed paracetamol concentration from 0 to 5 hours(0 to 5 hours after standardised meal (day 142))
- Tmax,para: the time of maximum observed paracetamol concentration from 0 to 5 hours(0 to 5 hours after standardised meal (day 142))
- Energy intake during ad libitum lunch(Day 142)
- Mean postprandial rating - Hunger (AUC30-300min/270 min) using visual analogue scales (VAS) from 30 up to 300 minutes during standardised breakfast meal(Day 142)
- Mean postprandial rating - Fullness (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal(Day 142)
- Mean postprandial rating - Overall appetite score (OAS) (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal(Day 142)
- Mean postprandial rating - Satiety (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal(Day 142)
- Mean postprandial rating - Prospective food consumption (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal(Day 142)