NCT02476019已完成2 期
A Double Blind, Randomized, Placebo-controlled, Single Center, Phase 2a Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 463588 (ISIS-FGFR4RX, an Antisense Inhibitor of Fibroblast Growth Factor Receptor 4) Administered Subcutaneously Once Weekly for 13 Weeks in Obese Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Energy Expenditure using both room calorimetry and hood (metabolic cart) calorimetry
研究概览
简要总结
The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISIS-FGFR4RX.
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)
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
- •Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements
- •Male or female patients between the age of 18-65 years, inclusive
- •Females: Must be post-menopausal (defined as 12 months of spontaneous amenorrhea in females > 55 years of age or, in females ≤ 55 years, 12 months of spontaneous amenorrhea without an alternative medical cause and FSH levels in the postmenopausal range for the laboratory involved)
- •Males: Surgically sterile, abstinent or if engaged in sexual relations with women of childbearing potential, patient is utilizing an acceptable contraceptive method during and for 5 months after the last dose of ISIS 463588 or placebo (Study Drug)
- •Body Mass Index (BMI) between 30.0 and 40.0 kg/m2, inclusive
- •Patients who are willing to comply with all scheduled visits, treatment plans, laboratory tests and other study procedures
- •Agree to abstain from alcoholic beverages for at least 48 hours prior to clinic visits
- •Agree to maintain current diet and exercise regimen from Screening until End-of-Study
排除标准
- •Clinically significant abnormalities in medical history (e.g., previous acute coronary syndrome within 6 months of Screening, major surgery within 3 months of Screening) or physical examination
- •Positive test for HIV, hepatitis B or C at Screening
- •Hypothyroidism or Hyperthyroidism
- •Weight change > 5% in the 3 months prior to Screening
研究组 & 干预措施
ISIS-FGFR4RX
Experimental
ISIS-FGFR4RX administered subcutaneously
干预措施: ISIS-FGFR4RX (Drug)
Placebo
Placebo Comparator
Placebo administered subcutaneously
干预措施: Placebo (Drug)
结局指标
主要结局
Energy Expenditure using both room calorimetry and hood (metabolic cart) calorimetry
时间窗: From baseline to the average of weeks 14 and 16
As measured by: * Resting Metabolic rate (kcal/min) * Resting metabolic rate adjusted for changes in body composition (kcal/min) * Resting fat oxidation (grams/24 hr)
次要结局
- Safety and Tolerability will be assessed by determining the incidence, and severity of adverse effects and changes in laboratory evaluations within each treatment group.(33 weeks)
研究者
研究点 (1)
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