EUCTR2016-002833-31-GB进行中（未招募）1 期
A randomized, patient and investigator blinded, placebo-controlled, multicenter study to assess the safety, tolerability, pharmacokinetics and efficacy of LMB763 in patients with non-alcoholic steatohepatitis (NASH)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 121
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
- •- Male and female patients 18 years or older (at the time of the screening visit)
- •- Presence of NASH as demonstrated by ONE of the following:
- •1) Histologic evidence of NASH based on liver biopsy obtained 2 years or less before randomization with a diagnosis consistent with NASH, fibrosis level F1, F2 or F3, in the absence of a histological diagnosis of alternative chronic liver diseases AND ALT = 60 IU/L (males) or = 40 IU/L (females)
- •2) Phenotypic diagnosis of NASH based on the presence of ALL THREE of the following:
- •- ALT = 60 IU/L (males) or = 40 IU/L (females) AND
- •- BMI = 27 kg/m2 (in patients with a self-identified race other than Asian) or =23 kg/m2 (in patients with a self-identified Asian race) AND
- •- Diagnosis of Type 2 diabetes mellitus by having either: HbA1C = 6.5% OR Symptoms of diabetes plus hyperglycemia as indicated by fasting plasma glucose =126 mg/dl (= 7.0 mmol/l), two hour plasma glucose concentration =200mg/dl (=11.1 mmol/l, two hours after 75g anhydrous glucose in an oral glucose tolerance test (OGTT)
- •Drug therapy for Type 2 diabetes mellitus
- •- Male and female patients 18 years or older (at the time of the screening visit)
- •- Liver fat = 10% at baseline as determined by the reading of the central MRI laboratory of locally produced images
- •- Presence of NASH as demonstrated by ONE of the following:
- •3. Histologic evidence of NASH based on liver biopsy obtained 2 years or less before randomization with a diagnosis consistent with NASH, fibrosis level F1, F2 or F3, in the absence of a histological diagnosis of alternative chronic liver diseases
- •ALT = 43IU/L (males) or = 28 IU/L (females)
- •4. Phenotypic diagnosis of NASH based on the presence of ALL THREE of the following:
- •- ALT = 43 IU/L (males) or = 28 IU/L (females) AND
- •- BMI = 27 kg/m2 (in patients with a self-identified race other than
- •Asian) or =23 kg/m2 (in patients with a self-identified Asian race) AND
- •- Diagnosis of Type 2 diabetes mellitus by having either:
- •- HbA1C = 6.5%
- •- Symptoms of diabetes plus hyperglycemia as indicated by
- •- fasting plasma glucose =126 mg/dl (= 7.0 mmol/l)
- •- two hour plasma glucose concentration = 200mg/dl (= 11.1 mmol/l two hours after 75g anhydrous glucose in an oral glucose tolerance test (OGTT)
- •- Drug therapy for Type 2 diabetes mellitus
- •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 144
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 48
排除标准
- •Cohort 1 and 2
- •- Current use of obeticholic acid (OCA)
- •- New initiation of GLP-1 agonists such as liraglutide, exenatide , lixisenatide, albiglutide or dulaglutide within 3 months of screening
- •- Patients on treatment with the following medicines UNLESS they are on a stable dose (± 25% of current dose) for at least 1 month before randomization: anti-diabetic medications, insulin (if =25% change in dose), beta-blockers, thiazide diuretics, fibrates, statins, niacin, ezetimibe, vitamin E (if doses > 200 IU/day; doses > 800 IU/day are prohibited), thyroid hormone, psychotropic medications, estrogen or estrogen containing birth control. For oral anti-diabetic medications, no more than one step up in local prescribing guidelines will be allowed.
- •- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 5 days (approximately 5 times the terminal half life) after stopping study medication
- •- Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more than 20 g/day in females and more than 30 g/day in males, on average) and/or a score on the AUDIT questionnaire =8 as administered by the site as part of the medical history
- •- History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during screening and baseline. Marijuana use is not allowed if it is determined to be medically inappropriate by the investigator
- •- Calculated eGFR less than 60 mL/min (using the MDRD formula)
- •- Presence of cirrhosis on liver biopsy or clinical diagnosis
- •- Clinical evidence of hepatic decompensation or severe liver impairment
- •- History or presence of other concomitant liver diseases
- •- History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
- •- Patients with contraindications to MRI imaging
- •- For those patients that have had a previous biopsy: Significant weight loss (>15%) or change in clinical status (in the opinion of the investigator) since the diagnostic liver biopsy
研究者
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