An Investigation of the Effect of High Dose s.c. Semaglutide on Gastric Emptying in Participants With Obesity
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- AUC,para: The area under the paracetamol plasma concentration-time curve following a standardised meal
研究概览
简要总结
The purpose of the study is to determine the effect of semaglutide on gastric emptying in people with obesity. Participants will receive either semaglutide or placebo, and the treatment assigned will be decided by chance. Semaglutide is a medicine that doctors can already prescribe, while placebo contains no active medicine.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-64 years (both inclusive) at the time of signing the informed consent.
- •Male or female (sex assigned at birth, inclusive of all gender identities).
- •Body mass index (BMI) between 30.0 - 44.9 kilogram per meter square (kg/m^2) (both inclusive) at screening. Obesity should be due to excess adipose tissue, as judged by the investigator.
排除标准
- •Known or suspected hypersensitivity to study intervention(s) (including paracetamol) or related products.
- •Use of prescription medicinal products or non-prescription drugs, including any herbal medicine known to interfere with the metabolic CYP pathways, such as perikon (St. John's Wort), within 14 days (or within 5 half-lives of the medicinal product, whichever is longest) of screening, with the exception of use of routine vitamins (vitamins used within a normal dose reference interval) and occasional use of paracetamol/acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation.
- •Impaired liver function defined as any of the below:
- •Alanine Aminotransferase (ALT) greater than or equal to (>= ) 2.5 times the upper limit of normal (ULN)
- •Aspartate Aminotransferase (AST) >=2.5 times ULN
- •Total bilirubin greater than (>) 1.5 times ULN
研究组 & 干预措施
Placebo
Participants will receive placebo matched semaglutide administered subcutaneously once weekly at multiple dose levels.
干预措施: Placebo semaglutide (Drug)
Placebo
Participants will receive placebo matched semaglutide administered subcutaneously once weekly at multiple dose levels.
干预措施: Paracetamol (Drug)
Semaglutide
Participants will receive semaglutide administered subcutaneously once weekly at multiple dose levels.
干预措施: Semaglutide (Drug)
Semaglutide
Participants will receive semaglutide administered subcutaneously once weekly at multiple dose levels.
干预措施: Paracetamol (Drug)
结局指标
主要结局
AUC,para: The area under the paracetamol plasma concentration-time curve following a standardised meal
时间窗: Day 177
Measured in hour micrograms per millilitre (h\*µg/mL).
次要结局
- AUC,para: The area under the paracetamol plasma concentration-time curve following a standardised meal(Day 177)
- Cmax,para; Maximum observed paracetamol plasma concentration following a standardised meal(Day 177)
- tmax;para: Time to maximum observed paracetamol plasma concentration(Day 177)