A Randomized, Parallel-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Semaglutide Implant
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Area under the plasma concentration-time curve (AUC)
研究概览
简要总结
The study will evaluate the safety, tolerability and drug levels of a semaglutide implant placed just under the skin for a period of 4 weeks compared to 4 weekly injections of semaglutide (Wegovy) in overweight/obese participants who are otherwise healthy..
详细描述
This open label, randomized, parallel-group study will evaluate participants with a body mass index (BMI) between 27 and 40 kg/m2 (inclusive). Safety, tolerability and PK data will be collected and evaluated for the 4-week treatment period. Participants will undergo a Screening Visit and those who meet eligibility will be randomized (1:1) to one of 2 study groups:
- Group 1: Semaglutide Implant (NPM-139)
- Group 2: Semaglutide 0.25 mg SC once weekly All participants will be domiciled for at least 48 hours following insertion of the implant (Group 1) or first dose of semaglutide 0.25 mg (Group 2).
Subsequently, participants will return to the clinic weekly until study end. At each of these visits, participants will have blood samples drawn for PK. After sample collections, site staff will administer semaglutide injections to participants in Group 2.
After 4 weeks of treatment (end of study), final PK samples will be collected and participants with implants will undergo a brief implant removal procedure under local anesthetic.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* BMI between 27 and 40 kg/m2 (inclusive)
- •* HbA1c \/= 60 mL/m2
- •* No significant health issues in the opinion of the Investigator that would preclude study participation, as determined by medical history and physical examination
排除标准
- •Type 1 or Type 2 Diabetesa
- •A clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the Investigator
- •Treatment with glucose lowering agent(s) within 3 months before Screening
研究组 & 干预措施
Semaglutide Implant (NPM-139)
Each participants in this arm will receive one Semaglutide Implant (NPM-139) which will be inserted subcutaneously in the upper outer arm and subsequently removed after 4 weeks of treatment.
干预措施: Semaglutide Implant (NPM-139) (Combination Product)
Semaglutide (Wegovy) weekly injection
Each participant in this arm will receive Semaglutide (Wegovy) 0.25 mg subcutaneous injection weekly for 4 weeks of treatment.
干预措施: Semaglutide (Wegovy) weekly injection (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve (AUC)
时间窗: 4 weeks
total semaglutide concentration
Maximum plasma concentration (Cmax)
时间窗: 4 weeks
Maximal semaglutide concentration
Time to maximum semaglutide concentration (Tmax)
时间窗: 4 weeks
Time to reach maximal semaglutide concentration
Adverse Events
时间窗: 4 weeks
Incidence of treatment-emergent adverse events
次要结局
未报告次要终点