The Effect of Oral Semaglutide 50 mg Once-daily on Energy Intake, Gastric Emptying, Appetite, Control of Eating and Pharmacokinetics in Participants With Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Relative change in energy intake during ad libitum lunch
研究概览
简要总结
This study tests if semaglutide tablets of 50 mg can help people with obesity to lower their food intake compared to placebo. This study also tests how semaglutide 50 mg works on appetite, control of eating (such as cravings and restraints) and how long time the food stays in the stomach after a meal.
In addition, how much semaglutide is in the blood will also be tested. Participants will either get semaglutide or placebo - which treatment participants will get is decided by chance. Participants will receive one semaglutide (or placebo) tablet per day during the 20-week treatment period. The dose of semaglutide is slowly increased every 4 weeks during the study to reach the treatment dose of 50 mg semaglutide taken for 4 weeks.
The study lasts for up to 29 weeks for each person and includes a screening period (up to 4 weeks), a treatment period (20 weeks) and a follow-up period (total of 5 weeks after the last dosing). Participants will have 12 visits with the study doctors at the institute.
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
- 是
入选标准
- •Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent
- •Body mass index between 30.0 and 45.0 kilogram per meter square (kg/m^2) (both inclusive)
排除标准
- •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 participant safety or compliance with the protocol
- •Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions
研究组 & 干预措施
Semaglutide
干预措施: Semaglutide D Dose 1 (Drug)
Semaglutide
干预措施: Semaglutide D Dose 2 (Drug)
Semaglutide
干预措施: Semaglutide D Dose 3 (Drug)
Semaglutide
干预措施: Semaglutide C Dose 4 (Drug)
Semaglutide
干预措施: Semaglutide C Dose 5 (50 mg) (Drug)
Placebo
干预措施: Placebo (Semaglutide C) (Drug)
Placebo
干预措施: Placebo ( Semaglutide D) (Drug)
结局指标
主要结局
Relative change in energy intake during ad libitum lunch
时间窗: Baseline to Day 140
Measured in Percentage
次要结局
- Mean postprandial rating - satiety(Day 140)
- t½,sema,50mg,SS terminal half-life of the log concentration time curve(Day 140 to 175)
- Change in amount of food consumed during ad libitum lunch(Baseline to Day 140)
- Cmax,para(0-5h after standardised meal, Day 141)
- Change in body weight(Baseline to Day 141)
- AUC0-24h,sema,50mg,ss area under these semaglutide-time curve (0-24h) during a dosing interval at steady state(Day 140 to 141)
- Change in energy intake during ad libitum lunch(Baseline to Day 140)
- AUC0-1h,para(0-1h after standardised meal, Day 141)
- tmax,para(0-5h after standardised meal, Day 141)
- tmax,sema,50mg,ss from last dosing to maximum concentration of semaglutide at steady state for semaglutide 50 mg(Day 140 to 175)
- Mean postprandial rating - hunger(Day 140)
- Mean postprandial rating - fullness(Day 140)
- Food cravings assessed by Control of Eating Questionnaire (COEQ)(Day 139)
- Cmax,sema,50mg,ss maximum concentration at steady state of semaglutide 50 mg(Day 140 to 175)
- CL/Fsema,50mg,ss total apparent clearance for semaglutide 50 mg at steady state(Day 140 to 175)
- Vz/Fsema,50mg,ss apparent volume of distribution during elimination for semaglutide 50 mg at steady state(Day 140 to 175)
- AUC0-5h,para(0-5h after standardised meal, Day 141)
- Mean postprandial rating - prospective food consumption(Day 140)
- Mean postprandial rating - overall appetite score (OAS)(Day 140)
- Vss/Fsema,50mg,ss apparent volume of distribution at steady state for semaglutide 50 mg(Day 140 to 175)