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）：美国的肥胖症患病率已升至流行比例。在存在合并症危险因素的情况下，体重指数（BMI）> = 30 kg/m 2的患者的体重减轻（BMI）> = 30 kg/m 2以及患有BMI> = 27 kg/m 2的患者的体重减轻。但是，目前，由于缺乏疗效，副作用或禁忌症，可用的治疗方法很少，因此减轻体重的药理治疗选择无法为许多肥胖患者提供足够的益处。因此，需要开发新的治疗肥胖治疗方法。 Zonisamide是一种目前以抗癫痫药销售的药物，已被证明可以在我们小组进行的为期16周的初步研究中促进肥胖患者的重大体重减轻。但是，在美国拥有Zonisamide独家营销权的制药公司将不会对更长的持续时间进行进一步的研究，以寻求新的适应症，因为该药物的市场排他性将在不到两年的时间内到期。 由于Zonisamide可能是我们对抗肥胖症斗争的潜在武器，因此我们希望通过一项随机临床试验进一步追求这一想法，该试验检查了一年多年来该药物的功效。由于我们的初步试验设计不允许我们评估较小剂量的Zonisamide是否也可能有效，因此除了评估长期疗效和安全性外，我们还将检查本研究中的剂量反应。我们还将系统地评估通过Zonisamide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。