NCT00993421终止2 期
LY377604 + Sibutramine Hydrochloride Monohydrate: A Phase 2 Weight Loss Efficacy Study in Overweight/Obese Men and Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 343
- 试验地点
- 1
- 主要终点
- Percent Change in Body Weight From Baseline to 24 Week Endpoint
研究概览
简要总结
The purpose of this study is to determine if LY377604 + sibutramine work better than LY377604 or sibutramine alone in the treatment of obesity.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are between the body mass index (BMI) of 27 and 45 kg/m^2, inclusive, at the time of screening.
排除标准
- •Have a Diastolic Blood Pressure (DBP) greater than 90 mm Hg or less than 55 mm Hg, and/or Systolic Blood Pressure (SBP) >140 mm Hg or <90 mmHg, confirmed by at least 1 repeat measurement. Subjects with hypertension treated with antihypertensive medication are not excluded if blood pressure is within the prescribed limits and they are not treated with excluded medications. Changes in antihypertensive medication are not permitted within 30 days prior to randomization
- •Previous history of poorly controlled hypertension, (that is, >160/100 or hypertension which requires more than 2 drugs for control).
- •Have a pulse rate >90 bpm or <50 bpm.
- •Evidence or history of prior significant cardiovascular disease, coronary artery disease, cardiovascular surgery, significant valvular disease, heart failure, arrhythmias, sick sinus syndrome or stroke.
- •Current treatment with β-blockers, calcium channel blockers, digitalis glycosides (for example, digoxin, etc), or clonidine.
- •Recent treatment (within 2 weeks prior to randomization) with catecholamine-depleting drugs (such as reserpine or tetrabenazine, monoamine oxidase inhibitors (MAOIs).
- •Current treatment with serotonergic drugs, such as selective serotonin reuptake inhibitors (SSRI), any drug that is a serotonin, norepinephrine, or dopamine reuptake inhibitor, "triptan" or ergot therapies for migraine or nausea, or serotonin-releasing agents.
- •Treatment with significant inhibitors of Cytochrome P2D6 (CYP2D6), such as bupropion, fluoxetine, paroxetine, quinidine, duloxetine, amiodarone, cimetidine, chlorpheniramine, clomipramine, doxepin, haloperidol, methadone, mibefradil, and ritonavir.
- •Participants with bronchospastic diseases or who are treated with bronchodilators or other prescription or nonprescription beta adrenergic agonists.
- •Peripheral vascular disease
- •History of thyrotoxicosis
- •History of seizures (except for childhood febrile convulsion) or at increased risk of seizures (for example, history of significant head trauma or intracranial surgery).
- •Have had a significant change in weight, defined as a gain or loss of at least 4 kg (9 lb) in the 90 days prior to randomization
- •Have had bariatric surgery (for example, gastric banding or gastric bypass)
- •Have had liposuction within 90 days prior to randomization
- •Have a disease that affects adipose mass or distribution of energy balance (for example, Cushing's syndrome, uncontrolled hyper- or hypothyroidism).
- •Have taken in the 30 days prior to randomization, a medication, herbal product, or nutritional supplement that affects adipose mass or distribution or energy balance, such as glucocorticoids, antiretrovirals, atypical antipsychotics, lithium, valproic acid, lamotrigine, or other anticonvulsants, mirtazapine, bupropion, phentermine, sibutramine, orlistat, rimonabant, amphetamine, or ephedra-containing supplements. Note: Medications that have small and transient effects on weight or medications that may affect weight independent of adipose mass (for example, estrogens or diuretics), may be continued, but may not be started, stopped, or changed during the course of the study.
- •Have been diagnosed with an eating disorder, such as anorexia, bulimia, binge eating disorder, or nocturnal eating disorder.
- •Have diabetes mellitus treated with medication, or type 2 diabetes mellitus managed with diet and exercise with hemoglobin A1c (HbA1C) >7.0%.
- •Symptomatic cholelithiasis in the 90 days prior to randomization.
- •Any lifetime history of suicide attempt.
- •History of major depressive disorder in the last 2 years or any lifetime history of severe psychiatric disorders (for example, schizophrenia or bipolar disorder).
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: Placebo sibutramine (Drug)
placebo
Placebo Comparator
干预措施: Placebo Metoprolol (Drug)
placebo
Placebo Comparator
干预措施: Placebo LY377604 (Drug)
LY377604 (75 mg)
Experimental
干预措施: LY377604 (Drug)
LY377604 (75 mg)
Experimental
干预措施: Placebo sibutramine (Drug)
LY377604 (75 mg)
Experimental
干预措施: Placebo Metoprolol (Drug)
sibutramine (30 mg)/metoprolol (200 mg)
Active Comparator
干预措施: Sibutramine (Drug)
sibutramine (30 mg)/metoprolol (200 mg)
Active Comparator
干预措施: Metoprolol (Drug)
LY377604 (40 mg)/sibutramine (30 mg)
Experimental
干预措施: LY377604 (Drug)
LY377604 (40 mg)/sibutramine (30 mg)
Experimental
干预措施: Sibutramine (Drug)
LY377604 (40 mg)/sibutramine (30 mg)
Experimental
干预措施: Placebo Metoprolol (Drug)
LY377604 (75 mg)/sibutramine (30 mg)
Experimental
干预措施: LY377604 (Drug)
LY377604 (75 mg)/sibutramine (30 mg)
Experimental
干预措施: Sibutramine (Drug)
LY377604 (75 mg)/sibutramine (30 mg)
Experimental
干预措施: Placebo Metoprolol (Drug)
LY377604 (15 mg)/sibutramine (30 mg)
Experimental
干预措施: LY377604 (Drug)
LY377604 (15 mg)/sibutramine (30 mg)
Experimental
干预措施: Sibutramine (Drug)
LY377604 (15 mg)/sibutramine (30 mg)
Experimental
干预措施: Placebo Metoprolol (Drug)
LY377604 (75 mg)/sibutramine (15 mg)
Experimental
干预措施: LY377604 (Drug)
LY377604 (75 mg)/sibutramine (15 mg)
Experimental
干预措施: Sibutramine (Drug)
LY377604 (75 mg)/sibutramine (15 mg)
Experimental
干预措施: Placebo Metoprolol (Drug)
结局指标
主要结局
Percent Change in Body Weight From Baseline to 24 Week Endpoint
时间窗: Baseline, 24 weeks
Body weight percentage change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body weight, age, gender were used as covariates.
次要结局
- The Mean Change in Body Weight From Baseline to 24 Week Endpoint(Baseline, 24 weeks)
- Percentage of Participants Who Achieve a Minimum of 10% Weight Loss From Baseline at 24 Weeks(24 weeks)
- Change in Heart Rate From Baseline to 24 Week Endpoint(Baseline, 24 weeks)
- Change in Blood Pressure From Baseline to 24 Week Endpoint(Baseline, 24 weeks)
- Change in Body Composition Using Dual Energy X-ray Absorptiometry (DXA) From Baseline to 24 Week Endpoint(Baseline, 24 weeks)
- Change in Waist Circumference From Baseline to 24 Week Endpoint(Baseline, 24 weeks)
- Percentage Change in Waist Circumference From Baseline to 24 Week Endpoint(Baseline, 24 weeks)
- Change in Total Cholesterol From Baseline to 24 Weeks Endpoint(Baseline, 24 weeks)
- Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to 24 Weeks Endpoint(Baseline, 24 weeks)
- Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to 24 Weeks Endpoint(Baseline, 24 weeks)
- Change in Triglycerides From Baseline to 24 Weeks Endpoint(Baseline, 24 weeks)
- Change From Baseline for Obesity Weight Loss Quality of Life Instrument (OWL-QoL)(Baseline, 24 weeks)
- Change From Baseline in Vitality Scale of Medical Outcomes Short Form - 36 (SF-36) Scale(Baseline, 24 weeks)
- Change in Glycated Hemoglobin A1c (HbA1c) From Baseline(Baseline, 24 weeks)
- Change in Fasting Glucose From Baseline to 24 Weeks Endpoint(Baseline, 24 weeks)
- Change in Fasting Insulin From Baseline to 24 Weeks Endpoint(Baseline, 24 weeks)
- Change in Insulin Resistance From Baseline to 24 Weeks Endpoint(Baseline, 24 weeks)
- Pharmacokinetics: Area Under the Concentration Time Curve (AUC)(4 weeks, 12 weeks, and 24 weeks)
- Pharmacokinetics: Maximum Concentration (Cmax)(4 weeks, 12 weeks, and 24 weeks)
研究者
研究点 (1)
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