EUCTR2007-000993-22-SE进行中（未招募）不适用
A multi-centre, randomized, double-blind, placebo-controlled, parallel-group study in obese subjects investigating weight loss after repeated, subcutaneous doses of TM30338
7TM Pharma A/S0 个研究点开始时间: 2007年3月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •a)BMI between 30 to 40 kg/m2 inclusive and obese
- •b)Either male or female
- •c)Age 18 to 60 years inclusive
- •d)Stable lifestyle as defined by consistent smoking, exercise, and eating patterns for at least 6 months prior to screening and willingness to maintain these patterns for the course of the study
- •e)Stable weight over past 2 months i.e. a change in body weight < 3 kg as reported by the subject
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a)Use of any anorexigenic agent or food supplement, including but not limited to phentermine, fenfluramine, hypericum, phenylpropanolamine, orlistat, sibutramine and rimonabant/Acomplia
- •b)Use of any systemic or topical prescription medication within 7 days of the first administration of study drug with the exception of hormonal contraceptives, diuretics for hypertension, calcium antagonists, ACE inhibitors, ARB therapy, statins, progesterone, estrogen, levothyroxine, inhaled steroids, inhaled bronchodilators, topical medications with no significant systemic effect, and/or the occasional use of NSAIDS and/or antihistamines. NOTE: see Prior and Concomitant Therapy (10.5) for further restrictions.
- •c)Use of any systemic or topical non-prescription medication within 3 days of the first administration of study drug with the exception of vitamin/mineral supplements, topical medications with no significant systemic effect, and/or the occasional use of NSAIDS, acetaminophen, antihistamines, and/or other medication that, in the opinion of the Investigator, will not interfere with the study procedures or compromise the subjects safety. NOTE: see Prior and Concomitant Therapy (10.5) for further restrictions.
- •d)History of any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular (other than well-controlled hypertension or hyper/dyslipidaemia), respiratory (other than well-controlled asthma), metabolic, endocrine (other than well-controlled hypothyroidism), haematological, gall bladder or other major disorders
- •e)History of major DSM-IV psychiatric disorder including, but not limited to substance-related disorders, schizophrenia and other psychotic disorders, mood disorders (e.g. major depression, bipolar disorder), and anxiety disorders
- •f)History of eating disorders (e.g. bulimia, anorexia nervosa) or is regularly engaged in binge-eating or purging behaviour (i.e. self-induced vomiting or the misuse of laxatives, diuretics, or enemas)
- •g)Any psychological eating problems indicated at Screening in the 3-factor eating questionnaire [2].
- •h)Liver function test values > 1.5 fold the upper normal limit
- •i)Triglycerides > 6.8 mmol
研究者
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