EUCTR2019-001550-26-ES进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparingthe Efficacy and Safety of Tirzepatide versus Placebo in Patients withNonalcoholic Steatohepatitis (NASH) - SYNERGY-NASH
illy S.A0 个研究点目标入组 196 人开始时间: 2020年2月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 196
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
- •- Female or male 18 to 80 years of age (inclusive)
- •- Body Mass Index (BMI) = 27kg/m² and =50 kg/m2
- •- Participants with T2DM (HbA1c = 9.5% at screening, treated with diet and/or exercice, or treated with oral antihyperglycemic medication (as detailed in the protocol))
- •- Participants without diagnosed T2DM (HbA1c < 6.5% at screening and fasting glucose < 7.0 mmol/L)
- •- Diagnosis of NASH by liver biopsy
- •- NAFLD Activity Score (NAS) = 4 with = 1 point for each component
- •- Fibrosis stage 2 or 3 according to the NASH CRN scoring system
- •- Stable body weight for at least 3 months. For participants entering the study with a liver biopsy done between 3 to 6 months from the screening visit, body weight must be stable (<5% body weight change) for the period of time between the biopsy and the screening visit.
- •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 156
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •- Alcohol consumption > 14 units/week for women and > 21 units/week for men
- •- Fibrosis stages 0 and 1 according to the NASH CRN scoring system
- •- Cirrhosis (fibrosis stage 4)
- •- Platelet count < 150,000/mm3
- •- Evidence of other forms of chronic liver disease
- •- Uncontrolled T2DM
研究者
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