JPRN-jRCT2080223753已完成2 期
A Randomized, Double-blind, Dose-finding Study to Evaluate the Change in Weight After 12 Weeks Treatment With 4 Doses of LIK066 Compared to Placebo in Japanese Patients With Obesity Disease
ovartis Pharma K.K.0 个研究点目标入组 130 人开始时间: 2017年12月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •* Patients with obesity disease and inadequately controlled body weight with diet and/or exercise
- •* BMI >= 25 kg/m2 combined with at least two obesity-related comorbidities, or BMI >= 35 kg/m2 at least one obesity-related comorbidity
- •* Patients with FPG >= 110 mg/dL and/or 5.6% <= HbA1c <= 10.0%, or T2DM with HbA1c <= 10.0%
- •* Waist circumference at umbilical level >= 85 cm for male, >= 90 cm for female
- •* Visceral fat area >= 100 cm2
- •* Agreement to comply with the study-required life-style intervention and treatment during the full duration of the study
排除标准
- •* Pregnancy or lactating women
- •* Use of pharmacologically active weight-loss medications
- •* Bariatric surgery
- •* Ketoacidosis, lactic acidosis, hyperosmolar coma
- •* Symptomatic genital ingection or urinary tract infection in the 4 weeks prior to screening
- •* Gastro-intestinal (GI) disorders associated with chronic diarrhea
- •* Congestive heart failure, New York Heart Association (NYHA) class III or IV
研究者
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