Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of MB07811 for 12 Weeks Followed by a 6-Week Off Drug Phase in Subjects With Primary Hypercholesterolemia
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 80
- 试验地点
- 11
- 主要终点
- Evaluate the effects of MB07811 compared to placebo on LDL-C
研究概览
简要总结
A Phase 2 randomized, placebo controlled study assessing the efficacy, safety, and tolerability of MB07811 given orally to subjects with primary hypercholesterolemia for 12 weeks followed by a 6-week off drug phase.
详细描述
This is an outpatient, Phase 2, multicenter, double-blind, placebo-controlled, randomized, parallel-group study assessing the efficacy, safety, and tolerability of MB07811 given orally to subjects with primary hypercholesterolemia for 12 weeks. There will be a 3- to 6-week screening/run-in period, including washout of any lipid-modifying therapies (as needed) prior to randomization. Eligible subjects will be randomized (1:1:1:1) to placebo, or 3 different doses of MB07811 for 12 weeks. After the double-blind treatment phase, all randomized subjects will proceed into a 6-week off-drug phase. Assessments include: laboratory tests, adverse events (AEs), electrocardiograms (ECGs), vitals, and PK samples.
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
- •Body mass index (BMI) 18.50 - 40 kg/m2 inclusive at screening;
- •Fasting serum LDL-C ≥145 mg/dL at both Q2 and Q3 visits;
- •Fasting mean serum LDL-C <220 mg/dL from Q2 and Q3;
排除标准
- •History of clinically significant cardiovascular disease
- •Uncontrolled hypertension
- •Significant sinus bradycardia defined as <40 beats per minute (bpm);
- •Personal or family history of clinically significant unexplained syncope, near-syncope or unexplained sudden death or QT syndrome;
- •Holter monitor report demonstrating any abnormality that is clinically significant, including but not limited to PVC frequency > 1 per minute, any alert criteria or any other condition that requires further evaluation;
- •History of clinical significant arrhythmia;
- •Resting 12-lead ECG showing QTc >450 msec or <360 msec (males or females), any tachyarrhythmia or morphology change, or any other clinically significant abnormality;
- •Any other cardiovascular event requiring hospitalization;
- •History or presence of thyroid disorder or other metabolic/endocrine disorder that affects lipids or glucose; Exceptions: polycystic ovarian syndrome (PCOS) and impaired glucose tolerance (IGT) are allowed.
- •Liver disease, gallbladder disease, Gilbert's syndrome, biopsy-proven nonalcoholic steatohepatitis (NASH), positive serology for hepatitis B surface antigen (HBsAg) or hepatitis C antibodies; Exceptions: gallbladder disease treated with cholecystectomy
- •History of human immunodeficiency virus (HIV);
- •Subjects with a prior history of malignancy in past 5 years;Exceptions: Subjects with previous history of basal or squamous cell carcinoma of the skin, or cervical cancer in situ are allowed if successfully treated;
- •History of myopathy, including any history of statin-induced myopathy;
- •History of intolerance to statins (e.g., myalgias, elevated liver tests);
- •History of clinically significant psychiatric disorders, including but not limited to bipolar disorder, major depressive disorder, psychosis;
- •Renal dysfunction;
- •Alcohol and/or drug abuse within 12 months prior to screening;
研究组 & 干预措施
1
MB07811 Cohort 1
干预措施: MB07811 (Drug)
2
MB07811 Cohort 2
干预措施: MB07811 (Drug)
3
MB07811 Cohort 3
干预措施: MB07811 (Drug)
4
Cohort 4
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluate the effects of MB07811 compared to placebo on LDL-C
时间窗: 12-weeks of treatment
次要结局
- Evaluate the effects of MB07811 on other lipid markers compared to placebo(12 weeks)
- Assess the safety and tolerability of MB07811(after 12 weeks of treatment and during off-drug phase)