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临床试验/NCT02634151
NCT02634151已完成2 期

A 12-Week, Phase 2 Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy, Safety and Tolerability of Gemcabene in Subjects With Hypercholesterolemia Not Adequately Controlled on High-Intensity or Moderate-Intensity Stable Statin Therapy

NeuroBo Pharmaceuticals Inc.21 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2016年11月最近更新:
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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
105
试验地点
21
主要终点
Percent Change From Baseline in LDL-C at Week 12
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study was to assess the efficacy, safety, and tolerability of multiple doses of gemcabene 600 mg QD compared to placebo in patients with hypercholesterolemia not adequately controlled on high-intensity or moderate-intensity stable statin therapy. Patients with HeFH, ASCVD, or otherwise uncontrolled, may be included with baseline LDL-C value ≥ 100 mg/dL. Subjects were randomized 1:1 to gemcabene 600 mg once daily (QD) or placebo.

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 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Placebo

Placebo Comparator

Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

干预措施: Placebo (Drug)

Gemcabene 600 mg

Experimental

Participants on stable statin therapy received 600 milligrams (mg) of Gemcabene orally, once daily for 12 weeks.

干预措施: Gemcabene (Drug)

结局指标

主要结局

Percent Change From Baseline in LDL-C at Week 12

时间窗: Baseline, Week 12

次要结局

  • Percent Change From Baseline in VLDL-C(Baseline, Weeks 2, 4, 8 and 12)
  • Change From Baseline in VLDL-C(Baseline, Weeks 2, 4, 8 and 12)
  • Percent Change From Baseline in HDL-C(Baseline, Weeks 2, 4, 8 and 12)
  • Change From Baseline in HDL-C(Baseline, Weeks 2, 4, 8 and 12)
  • Number of Participants Achieving LDL-C Reduction of ≥10%(Weeks 4, 8 and 12)
  • Number of Participants Achieving LDL-C Reduction of ≥15%(Weeks 4, 8 and 12)
  • Number of Participants Achieving LDL-C Reduction of ≥20%(Weeks 4, 8 and 12)
  • Number of Participants Achieving an LDL-C Value <100 mg/dL (2.59 mmol/L)(Weeks 4, 8 and 12)
  • Percent Change From Baseline in Apolipoprotein B(Baseline, Weeks 4, 8 and 12)
  • Change From Baseline in Apolipoprotein B(Baseline, Weeks 4, 8 and 12)
  • Percent Change From Baseline in Apolipoprotein A-I(Baseline, Weeks 4, 8 and 12)
  • Percent Change From Baseline in Apolipoprotein A-II(Baseline, Weeks 4, 8 and 12)
  • Change From Baseline in Apolipoprotein A-II(Baseline, Weeks 4, 8 and 12)
  • Change From Baseline in Apolipoprotein A-I(Baseline, Weeks 4, 8 and 12)
  • Percent Change From Baseline in Apolipoprotein C-II(Baseline, Weeks 4, 8 and 12)
  • Change From Baseline in Apolipoprotein C-II(Baseline, Weeks 4, 8 and 12)
  • Percent Change From Baseline in Apolipoprotein C-III(Baseline, Weeks 4, 8 and 12)
  • Change From Baseline in Apolipoprotein C-III(Baseline, Weeks 4, 8 and 12)
  • Percent Change From Baseline in Apolipoprotein E(Baseline, Weeks 4, 8 and 12)
  • Change From Baseline in Apolipoprotein E(Baseline, Weeks 4, 8 and 12)
  • Percent Change From Baseline in Lipoprotein(a)(Baseline, Weeks 4, 8 and 12)
  • Change From Baseline in Lipoprotein(a)(Baseline, Weeks 4, 8 and 12)
  • Percent Change From Baseline in High-sensitivity C-reactive Protein(Baseline, Week 12)
  • Change From Baseline in High-sensitivity C-reactive Protein(Baseline, Week 12)
  • Percent Change From Baseline in Fibrinogen(Baseline, Week 12)
  • Change From Baseline in Fibrinogen(Baseline, Week 12)
  • Percent Change From Baseline in Serum Amyloid A(Baseline, Week 12)
  • Change From Baseline in Serum Amyloid A(Baseline, Week 12)
  • Percent Change From Baseline in Adiponectin(Baseline, Week 12)
  • Change From Baseline in Adiponectin(Baseline, Week 12)
  • Change From Baseline in TC(Baseline, Weeks 2, 4, 8 and 12)
  • Percent Change From Baseline in TG(Baseline, Weeks 2, 4, 8 and 12)
  • Change From Baseline in TG(Baseline, Weeks 2, 4, 8 and 12)
  • Percent Change From Baseline in LDL-C by Statin Intensity Stratum(Baseline, Week 12)
  • Change From Baseline in LDL-C(Baseline, Weeks 2, 4, 8, 12 and average of weeks 8 and 12)
  • Percent Change From Baseline in LDL-C(Baseline, average of weeks 8 and 12)
  • Percent Change From Baseline in Non-HDL-C(Baseline, Weeks 2, 4, 8 and 12)
  • Change From Baseline in Non-HDL-C(Baseline, Weeks 2, 4, 8 and 12)
  • Change From Baseline in Framingham Risk Score(Baseline, Week 12)
  • Percent Change From Baseline in TC(Baseline, Weeks 2, 4, 8 and 12)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (21)

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