NCT00537420已完成2 期
A 24-Week, Blinded, Randomized, Placebo-Controlled Dose-Ranging Trial of Nasal PYY3-36 for Weight Loss in Healthy Obese Patients
Nastech Pharmaceutical Company, Inc.1 个研究点 分布在 1 个国家目标入组 551 人开始时间: 2007年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 551
- 试验地点
- 1
- 主要终点
- To evaluate the effect of increasing nasal PYY3 36 dosing on weight loss post 24 weeks of treatment
研究概览
简要总结
The purpose of this study is to determine the effect of nasal PYY3-36 on weight loss post 24 weeks of treatment.
详细描述
This is a multi-center, Phase 2 double-blind, randomized, placebo-controlled trial in healthy obese patients. The primary objective of the study is to evaluate the effect of increasing nasal PYY3-36 dosing on weight loss post 24 weeks of treatment.
Secondary Objectives:
- To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo
- To compare the weight loss post 12 and 24 weeks of treatment for each of the three nasal PYY3 36 dose groups versus the nasal placebo group
- To compare the proportion of patients who lose at least 5% and 10% of the baseline body weight post 12 and 24 weeks of therapy for each of the three nasal PYY3 36 dose groups versus the nasal placebo group
- To compare the weight loss and proportion of patients who lose at least 5% of the baseline body weight post 12 and 24 weeks of treatment with sibutramine versus capsule placebo
- To compare the weight loss and proportion of patients who lose at least 5% of the baseline body weight post 12 and 24 weeks of treatment with nasal placebo versus capsule placebo
- To compare the weight loss and proportion of patients who lose at least 5% of the baseline body weight post 12 and 24 weeks of treatment with sibutramine versus the nasal PYY3 36 dose groups
- To evaluate the effect of 12 and 24 weeks of treatment with nasal PYY3 36 and sibutramine on fasting lipid profile, plasma glucose, insulin, blood pressure and pulse, waist circumference and BMI
- To evaluate the effect of 24 weeks of treatment with nasal PYY3 36 and sibutramine on HbA1c levels
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Male or Female patients 18 and 65 years, inclusive;
- •BMI 30-43 kg/m2, inclusive;
- •In good health, determined by medical history and physical examination, as well as normal 12-lead ECG and vital signs;
- •Non-smoker and no use of tobacco or nicotine products for at least 3 months;
- •Females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile (including tubal ligation, hysterectomy) for at least 3 months, until 30 days following Study Completion be willing to use an approved method of contraception;
- •Has normal nasal mucosa.
排除标准
- •Previous surgical treatment for obesity;
- •Serious Medical Condition
- •Serious Psychiatric illness
- •Organic causes of obesity (e.g. untreated hypothyroidism)
- •Type 1 or Type 2 Diabetes;
- •Presence of uncontrolled hypertension
- •On prohibited concomitant medication
研究组 & 干预措施
1
Placebo Comparator
Nasal Placebo
干预措施: Nasal Placebo (Drug)
2
Placebo Comparator
Capsule Placebo
干预措施: Placebo Capsule (Drug)
3
Experimental
Nasal PYY3-36 200 ug
干预措施: PYY3-36 (Drug)
4
Experimental
Nasal PYY3-36 400 ug
干预措施: PYY3-36 (Drug)
5
Experimental
Nasal PYY3-36 600 ug
干预措施: PYY3-36 (Drug)
6
Active Comparator
Sibutramine 10 mg
干预措施: Sibutramine (Drug)
结局指标
主要结局
To evaluate the effect of increasing nasal PYY3 36 dosing on weight loss post 24 weeks of treatment
时间窗: 24 Weeks
次要结局
- To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo(24 Weeks)
研究者
研究点 (1)
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