EUCTR2009-010198-19-SE进行中（未招募）不适用
A Phase 2 12-week multi-center, randomized, double-blind, placebo-controlled, parallel-group adaptive design study to evaluate the safety and efficacy of LCQ for weight reduction and reduced LDL cholesterol in patients with obesity and mixed dyslipidemia.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Written informed consent to participate in the study, before any study related activities are performed, and is likely to comply with all study requirements, including dietary guidelines.
- •2.Age 18-75 years, inclusive.
- •3.Males, non-fertile females, and females of non-childbearing potential. Women must be (a) postmenopausal, defined as age >48 with 12 months of natural (i.e. spontaneous) amenorrhea or age >42 with >6 months of spontaneous amenorrhea with serum FSH levels > 30 mIU/mL and estradiol <30 pg/ml ; (b) 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy; or (c) have a documented history of tubal ligation at least 1 year prior to screening.
- •4.Patients with a history of overweight for 1 year or more with body mass index (BMI) of 30 to 42 kg/m2 inclusive.
- •5.Body weight at Visit 1 within 5% of their self-reported weight over the past three months and agreement to maintain the study-recommended diet (counseled during screening) and usual exercise habits during the full course of the study. Patients will not have participated in a formal weight loss program within the 3 months prior to screening Visit 1.
- •6.Patients with fasting mixed dyslipidemia at the first screening visit including:
- •- elevated LDL cholesterol of 2.6 to 4.14 mmol/L (100-160 mg/dl) inclusive
- •- fasting triglycerides of 1.7 to 5.0 mmol/L (150-520 mg/dl) inclusive
- •- HDL cholesterol in men <1.1 mmol/L (<42 mg/dl) and in women <1.3 mmol/L (<50 mg/dl)
- •7.Patients who are receiving a statin must meet the dyslipidemia criteria while on their statin and must have been on a stable dose for at least 2 months prior to the Visit 1 fasting lipids and safety screening. They must agree to maintain the same dose of statin throughout the trial duration.
- •8.Patients who have not been on fibrate or nicotinic (niacin) lipid lowering therapies within 2 months of Visit 1 are eligible for screening so long as they meet all other criteria. Patients on over-the-counter fish oils, prescription fish oils (Lovaza up to 4 g/day) or other natural product approaches to lipid lowering may remain on those as long as they meet other entry criteria.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.A history of type 1 diabetes or diagnosed type 2 diabetes, or other forms of diabetes mellitus. Women with a history of gestational diabetes occurring 5 or more years prior to screening are eligible if they meet the other metabolic criteria
- •2.Fasting plasma glucose > 7.0 mmol/L (>126 mg/dl) or HgbA1c >6.5 %
- •3.Known endocrine disorders that result in obesity including hypothalamic disorders, Cushing’s disease or recently diagnosed (within the prior 6 months) hypothyroidism
- •4.Genetic obesity syndromes, including Prader-Willi Syndrome
- •5.Dyslipidemia syndromes that require nicotinic acid or fibrates for control or need for accelerated treatment, including Triglycerides >5.0 mmol/L (520 mg/dl) and LDL cholesterol > 4.14 nmol (160 mg/dl)
- •6.Patients with known Type I or Type V chylomicronemia
- •7.For patients considered for the MRI sub-study: claustrophobia, waist circumference exceeding the bore size of the MRI scanner, and presence of ferromagnetic implants such as older pacemakers
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