Zonisamide for Weight Reduction in Obese Adults

唑尼沙胺用于肥胖成人减肥

• 批准号: 6868043
• 负责人: KISHORE M GADDE
• 金额: $ 31.57万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-04-01 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6868043
• 关键词: adult human (21+); clinical research; clinical trials; human subject; human therapy evaluation; nutrition disorder chemotherapy; obesity; patient oriented research; weight control; weight control agent

DESCRIPTION (provided by applicant): Obesity prevalence in the US has risen to epidemic proportions. Pharmacotherapy is indicated for weight reduction in patients with body mass index (BMI) >=30 kg/m 2 as well as those with BMI >=27 kg/m 2 in the presence of co-morbid risk factors. However, currently there are very few pharmacologic treatment options for weight reduction, and the available treatments fail to provide adequate benefit for many obese patients because of lack of efficacy, side effects, or contraindications. Hence, there is considerable need for developing new treatments for the management of obesity. Zonisamide, a drug that is currently marketed as an antiepileptic, has been shown to promote significant weight loss in obese patients in a 16-week preliminary investigation conducted by our group. However, the pharmaceutical company that has exclusive marketing rights for zonisamide in the US will not conduct further studies of longer duration with a larger sample of patients to seek a new indication, as the market exclusivity on this drug is due to expire in less than two years. Because Zonisamide can be a potential weapon in our fight against obesity, we wish to pursue this idea further via a randomised clinical trial examining the efficacy of the drug over a year. Since our preliminary trial design did not allow us to assess whether a smaller dose of zonisamide might also be effective, we will examine dose-response in this study in addition to assessment of long-term efficacy and safety. We will also systematically assess whether weight loss achieved with zonisamide treatment can reduce metabolic and cardiovascular risk factors.

描述（由申请人提供）：美国的肥胖流行率已上升到流行病的程度。药物治疗适用于体重指数 (BMI) >= 30 kg/m 2 以及 BMI >= 27 kg/m 2 存在共病危险因素的患者减轻体重。然而，目前用于减肥的药物治疗选择非常少，并且由于缺乏疗效、副作用或禁忌症，可用的治疗方法无法为许多肥胖患者提供足够的益处。因此，非常需要开发新的肥胖症治疗方法。 我们小组进行的一项为期 16 周的初步研究表明，唑尼沙胺是一种目前作为抗癫痫药上市的药物，可促进肥胖患者显着减轻体重。然而，拥有唑尼沙胺在美国独家营销权的制药公司不会再进行更长时间、更大样本患者的研究来寻求新的适应症，因为该药的市场独占权将在不到两年内到期。年。 由于唑尼沙胺可能成为我们对抗肥胖的潜在武器，因此我们希望通过一项随机临床试验来进一步研究这一想法，该试验检查该药物一年多的疗效。由于我们的初步试验设计不允许我们评估较小剂量的唑尼沙胺是否也可能有效，因此除了评估长期疗效和安全性之外，我们还将在本研究中检查剂量反应。我们还将系统地评估通过唑尼沙胺治疗实现的体重减轻是否可以减少代谢和心血管危险因素。