A Randomized, Double -Blind (Sponsor-Open), Placebo-Controlled Study to Assess the Effect of NT-0796 on Inflammation in Obese Participants at Risk of Cardiovascular Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Change in hsCRP levels
研究概览
简要总结
This trial is a Randomized, Double-Blind (Sponsor-Open), Placebo-Controlled Study to Assess the Effect of NT-0796 on Inflammation in Obese Participants at Risk of Cardiovascular Disease.
Participants will be admitted to an in-patient Clinical Research Unit on Day -1 and will be discharged on Day 30. The trial will include a 7-day out-patient safety follow-up period following the last dose of study treatment.
For the first approximately 20 participants effect of food will be evaluated on the Pharmacokinetics of NT-0796. MRI's will be conducted in a subset of participants.
详细描述
The goal of this clinical trial is to evaluate the effects of NT-0796 on inflammation in obese participants at risk of cardiovascular disease, evaluate the effects of NT-0796 on body weight and composition, to see how safe NT-0796 is, and how well it is tolerated and to measure the blood levels of NT-0796, with and without food.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 years or older.
- •Body mass index (BMI) ≥30 and ≤40 kg/m2 at screening.
- •Presence of 1 or more of the following risk factors for atherosclerotic cardiovascular disease:
- •History of controlled hypertension
- •History of hypercholesterolemia
- •History of high-density lipoprotein levels
- •Controlled Type 1 or Type 2 Diabetes mellitus
排除标准
- •History of stroke with residual neurological deficit within 2 years or transient ischemic attack within 6 months
- •History of acute coronary syndrome (ACS)
- •Stable angina.
- •Diagnosis of congestive heart failure
- •Evidence of past or current infection with Hepatitis B or Hepatitis C
研究组 & 干预措施
NT-0796
BID
干预措施: NT-0796 (Drug)
Placebo
BID
干预措施: NT-0796 (Drug)
结局指标
主要结局
Change in hsCRP levels
时间窗: Baseline to Day 28
Evaluate the effects of NT-0796 on inflammation.
次要结局
- Change in Body weight (kg)(Change from baseline to Day 28)
- Body composition(Change from baseline to Day 28)