NCT03320941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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Percentage Change From Baseline in Body Weight at Week 12
研究概览
简要总结
The purpose of the study is to evaluate the efficacy, tolerability and safety of LIK066 to support dose selection for Phase 3 development in Japanese adults with obesity disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Parallel Assignment
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with obesity disease and inadequately controlled body weight with diet and/or exercise
- •BMI ≥ 25 kg/m^2 combined with at least two obesity-related comorbidities, or BMI ≥ 35 kg/m^2 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 cm^2
- •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
研究组 & 干预措施
LIK066 2.5 mg
Experimental
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily for 12 weeks.
干预措施: LIK066 (Drug)
LIK066 10 mg
Experimental
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily for 12 weeks.
干预措施: LIK066 (Drug)
LIK066 25 mg
Experimental
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily for 12 weeks.
干预措施: LIK066 (Drug)
LIK066 50 mg
Experimental
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily for 12 weeks.
干预措施: LIK066 (Drug)
Placebo
Placebo Comparator
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage Change From Baseline in Body Weight at Week 12
时间窗: Baseline, Week 12
The dose-response relationship of LIK066 as measured by percent change from baseline in body weight relative to placebo after 12 weeks of treatment.
次要结局
- Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12(Baseline, Week 12)
- Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM)(Baseline, Week 12)
- Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG)(Baseline, Week 12)
- Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG)(Baseline, Week 12)
- Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol(Baseline, Week 12)
- Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL)(Baseline, Week 12)
- Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP)(Baseline, Week 12)
- Change From Baseline at Week 12 on Waist Circumference at Umbilical Level(Baseline, Week 12)
- Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c)(Baseline, Week 12)
- Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL)(Baseline, Week 12)
- Change From Baseline in Uric Acid at Week 12(Baseline, Week 12)
- Change From Baseline on Urine Albumin at Week 12(Baseline, Week 12)
- Change From Baseline at Week 12 on Systolic Blood Pressure (SBP)(Baseline, Week 12)
- Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP)(Baseline, Week 12)
- Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12(Baseline, Week 12)
- Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12(Baseline, Week 12)
- Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12(Baseline, Week 12)
- Pharmacokinetics - Plasma Trough Concentrations of LIK066(Week 12)
研究者
研究点 (1)
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