A Trial to Demonstrate Bioequivalence Between Semaglutide Formulations With the DV3396 Pen-injector and With the PDS290 Pen-injector in Subjects With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- AUC0-168h,2.4mg,SS: Area under the semaglutide concentration time curve following the last administration of semaglutide s.c. 2.4 mg
研究概览
简要总结
The study will look at how two different forms of semaglutide reach and stay in the blood after injection. None of the two forms of semaglutide have been approved by the authorities to treat obesity. Participants will get 1 of the 2 forms of semaglutide - which one is decided by chance. Participants will get the medicine as an injection under the skin of the stomach with the use of a pen-injector. The type of pen-injector is different for the two forms of semaglutide. The study staff will teach participants how to inject themselves with the medicine. As part of this training participants will self inject placebo (dummy medication) 3 times. Participants will take an injection once a week and will get 21 injections in total of study medication. The study will last for about 27-30 weeks. Participants will have 25 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic for 3 days and 2 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Women cannot take part if they are pregnant, breast-feeding or planning to become pregnant during the study period.
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
- None
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 18-65 years (both inclusive) at the time of signing informed consent
- •Body mass index (BMI) between 27.0 and 34.9 kg/m^2 (both inclusive)
- •Body weight between 70.0 and 130.0 kg (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 subject's safety or compliance with the protocol
- •Inability or unwillingness to perform self-injection
研究组 & 干预措施
DV3396
Participants will receive once-weekly doses of semaglutide administered with the DV3396 pen-injector (test drug product)
干预措施: Semaglutide (administered by DV3396 pen) (Drug)
PDS290
Participants will receive once-weekly doses of semaglutide administered with the PDS290 pen-injector (comparator drug product)
干预措施: Semaglutide (administered by PDS290 pen) (Drug)
结局指标
主要结局
AUC0-168h,2.4mg,SS: Area under the semaglutide concentration time curve following the last administration of semaglutide s.c. 2.4 mg
时间窗: 0-168 hours (Day 141-148) after last 2.4 mg dose
h\*nmol/L
Cmax,2.4mg,SS: Maximum observed semaglutide concentration following the last administration of semaglutide s.c. 2.4 mg
时间窗: 0-168 hours (Day 141-148) after last 2.4 mg dose
nmol/L
次要结局
- Tmax,2.4mg,SS: Time of maximum observed semaglutide concentration after last 2.4 mg dose(0-168 hours (Day 141-148) after last 2.4 mg dose)
- Vss/F1mg: Apparent volume of distribution at steady-state of semaglutide after last 1 mg dose(0-168 hours (Day 78-85) after last 1 mg dose)
- AUC0-168h,1mg,SS: Area under the semaglutide concentration time curve following the last administration of semaglutide s.c. 1 mg(0-168 hours (Day 78-85) after last 1 mg dose)
- Cmax,1mg,SS: Maximum observed semaglutide concentration following the last administration of semaglutide s.c. 1 mg(0-168 hours (Day 78-85) after last 1 mg dose)
- Tmax,1mg,SS: Time of maximum observed semaglutide concentration after last 1 mg dose(0-168 hours (Day 78-85) after last 1 mg dose)
- t½: Terminal elimination half-life of semaglutide after last 2.4 mg dose(0-1176 hours (Day 141-190) after last 2.4 mg dose)
- Cl/F2.4mg: Total apparent clearance of semaglutide after last 2.4 mg dose(0-168 hours (Day 141-148) after last 2.4 mg dose)
- Cl/F1mg: Total apparent clearance of semaglutide after last 1 mg dose(0-168 hours (Day 78-85) after last 1 mg dose)
- Vss/F2.4mg: Apparent volume of distribution at steady-state of semaglutide after last 2.4 mg dose(0-168 hours (Day 141-148) after last 2.4 mg dose)
- Change in body weight(From baseline (Day 1, pre-dose) until the end of treatment (Day 148))