A Proof-of-Concept, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of Oral NG101 in the Treatment of Side Effects in Healthy Adult Participants Administered a Single Subcutaneous Dose of a Glucagon-Like Peptide 1 Agonist
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Duration of GI-related adverse events
研究概览
简要总结
Adult participants with BMI between 22 - 35 kg/m2 will be enrolled and randomized to receive either NG101 (20 mg twice daily [BID]) or placebo for 5 days beginning on Day 1. On Day 2, all participants will receive a single subcutaneous injection of a Glucagon-like Peptide-1 (GLP-1) agonist (semaglutide). Participants will remain at the clinical research unit for the duration of the treatment period.
The goal of this clinical trial is to evaluate the safety and efficacy of NG101 compared to placebo, when also administered along with a GLP-1 agonist, in the management of gastrointestinal side effects commonly associated with GLP-1 agonists for overweight or obesity. Adverse event information will be collected. Gastrointestinal (GI)-specific questionnaires will be used to capture additional details if GI-related adverse events are reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult
- •Male or female
- •BMI between 22 - 35 kg/m2 at screening
排除标准
- •Presence or history of illness that might confound the results of the study or pose an -
- •History of presence of gastroparesis, gallbladder disease, acute or chronic pancreatitis, or surgery of the abdomen
- •History or presence of Type 1 or Type 2 diabetes
研究组 & 干预措施
NG101 20 mg BID
NG101 (metopimazine mesylate) 20 mg capsule BID + single SC dose of 0.5 or 1 mg semaglutide
干预措施: NG101 (Drug)
NG101 20 mg BID
NG101 (metopimazine mesylate) 20 mg capsule BID + single SC dose of 0.5 or 1 mg semaglutide
干预措施: Semaglutide Injectable Product (Drug)
Placebo
Placebo capsule BID + single SC dose of 0.5 or 1 mg semaglutide
干预措施: Placebo (Drug)
Placebo
Placebo capsule BID + single SC dose of 0.5 or 1 mg semaglutide
干预措施: Semaglutide Injectable Product (Drug)
结局指标
主要结局
Duration of GI-related adverse events
时间窗: 96 hours following GLP-1 agonist injection
Number of days with TEAEs of GI-related adverse events following GLP-1 agonist injection
Severity of GI-related adverse events
时间窗: 96 hours following GLP-1 agonist injection
Moderate and/or severe TEAES of GI-related adverse events following GLP-1 agonist injection
次要结局
- Number of TEAEs of GI-related adverse events(96 hours following GLP-1 agonist injection)