NCT03720574终止3 期
Efficacy and Safety of Lorcaserin and Behavioral Modification for Overweight and Obesity Management in Chinese Adult Obese Patients: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
Kanion & Huawe Medicine Co.,Ltd9 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年9月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- 5% responders
研究概览
简要总结
The purpose of this study is to assess the safety and weight loss effect of lorcaserin at the end of the first year of treatment (Week 48) in overweight and Chinese adult obese patients compared to 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged from 18 to 65 years (inclusive).
- •Able to walk and preform exercise program required by trial protocol.
- •Body Mass Index (BMI) within the range of 30 to 45 kg/m2 (obese) with or without co-morbid conditions or greater than or equal to 27 and less than 30 kg/m2 (overweight) with at least one treated or untreated comorbid condition (hypertension, dyslipidemia, cardiovascular disease, untreated abnormal glucose metabolism, sleep apnea). For untreated co-morbid conditions, the condition must be considered by the Investigator as clinically stable.
- •Prior to the study, patients should be able to voluntarily participate in this study and sign informed consent form approved by IRB/ICE
排除标准
- •Not suitable to participate in the study in the opinion of the Investigator, including an existing physical or mental condition that prevents compliance with the protocol.
- •Patients who had a history of Type 1 diabetes mellitus or confirmed diagnosis of Type 2 diabetes mellitus for more than 6 months.
- •Recent history (within 1 years before entering the study) of major depression, anxiety, or other psychiatric disease requiring treatment with prescription medication (e.g., SSRI's, SNRI's [including buproprion], tricyclics, antipsychotics, lithium). Use of SSRI's and SNRI's (including buproprion) for reasons other than active psychiatric indications (e.g., migraine, weight loss, smoking cessation) must meet a 3-month washout.
- •Total score on the Beck Depression Inventory-II (BDI-II) >
- •Binge Eating Scale score >
- •History of epilepsy or other seizure disorder.
- •Has done or anticipate Surgical procedure for the treatment of obesity (i.e., gastric bypass, gastric banding).
- •Anticipation of surgery during the study period that may interfere with completion or compliance with the protocol.
- •Uncontrolled hypertension after certain treatments, defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥ 100 mmHg.
- •History of valve replacement surgery or CABG or other invasive cardiovascular surgical procedure. A diagnostic cardiac catheterization does not exclude.
- •History of Myocardial infarction(MI), Cerebral Vascular Accident(CVA), or transient ischemic attack(TIA). Reversible ischemic neurological deficits (RIND), cardiac arrhythmia requiring medical or surgical treatment within 3 months of screening.
- •Major surgical procedure (intrathoracic, intracranial, intraperitoneal, liposuction) within 6 months of screening
- •History of unstable angina
- •History of congestive heart failure caused by insufficiency or stenosis of any heart valve
- •History of pulmonary artery hypertension
- •Symptomatic untreated congestive heart failure of any etiology (stably treated NYHA class I or II CHF of ischemic or hypertensive etiology is acceptable)
- •History of organ/bone marrow transplantation
- •Abnormal TSH lab value > 1.5x ULN
- •Hyperthyroidism, including abnormal screening lab values with FT4 > ULN and TSH < LLN.
- •Fasting triglycerides > 499 mg/dL(5.64 mmol/L) ,if elevated at Screening, but not on a subsequent re-check, patient will be eligible. Otherwise, patients can't be enrolled.
- •LDL-cholesterol ≥ 190 mg/dL(4.92 mmol/L).
- •HbA1c greater than 9.0%
- •Fasting glucose > 270 mg/dL(11.0 mmol/L) ,if elevated at Screening, but not on a subsequent re-check, patient will be eligible. Otherwise, patients can't be enrolled.
- •Clinically significant abnormal hepatic (e.g., AST or ALT > 2.5x ULN, or total bilirubin > 1.5x ULN) or renal function lab tests (e.g., creatinine > 1.25x ULN) suggestive of hepatic or renal impairment.
- •Positive result of HIV, hepatitis B or hepatitis C screens.
- •Malignancy within 5 years of the screening visit (except basal cell or squamous cell carcinoma with clean surgical margins).
- •Treatment with over-the counter weight loss products or appetite suppressants (including herbal weight loss agents) within 1 month of the screening visit, or with a prescription anti-obesity drug (phentermine, sibutramine, orlistat) or lipid dissolving injections within 3 months.
- •Over 3 days of treatment with oral or parenteral corticosteroids within 2 weeks of the screening visit.
- •Recent history (within 2 years prior to the screening visit) of alcohol or drug abuse.
- •Significant change in smoking habits within 3 months prior to screening.
- •Participated in any clinical study with an investigational drug, biologic, or device within 3 month prior to screening.
- •Significant change in diet or level of physical activity or change in weight of > 5 kg within 3 month prior to screening.
- •Use of liquid weight loss diet within 6 months prior to screening.
- •Disagree to continue to use an accepted method of birth control during and for at least 3 months after last study medication administration.
研究组 & 干预措施
Lorcaserin 10 mg BID
Experimental
Lorcaserin 10 mg tablet each morning and evening
干预措施: Lorcaserin 10 mg BID (Drug)
Matching Placebo BID
Placebo Comparator
Matching Placebo tablet each morning and evening
干预措施: Matching Placebo BID (Drug)
结局指标
主要结局
5% responders
时间窗: 48 weeks
Proportion (%) of subjects who lose at least 5% of their baseline body weight at week 48
次要结局
- IWQOL-LITE score change(48 weeks)
- Lipids change(48 weeks)
- Glucose and HbA1c change(48 weeks)
- Weight change(48 weeks)
- 10% responders(48 weeks)
- circumference and hip circumference change(48 weeks)
- Blood Pressure change(48 weeks)
- CV Risk Markers change(48 weeks)
研究者
研究点 (9)
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