NL-OMON44568已完成2 期
A 12-week randomized, patient and investigator blinded, placebo-controlled, parallel group study to investigate the efficacy of LIK066 in obese patients with non-alcoholic steatohepatitis (NASH) - Efficacy of LIK066 for the treatment of non-alcoholic steatohepatitis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 8
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
- 18 至 99（—）
入选标准
- •Presence of NASH as demonstrated by one of the following:
- •Histologic confirmed NASH based on liver biopsy obtained 2 years or less before randomization with a fibrosis level of F1, F2 or F3, in the absence of a histological diagnosis of alternative chronic liver diseases AND ALT * 50 IU/L (males) or * 35 IU/L (females) at screening;Or
- •Phenotypic diagnosis of NASH based on presence of all three of the following at screening:
- •- ALT * 50 IU/L (males) or * 35 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 HbA1C: * 6.5% and * 10%
排除标准
- •- Use of GLP-1 agonists such as liraglutide, exenatide, lixisenatide, albiglutide or dulaglutide; SGLT-2 inhibitors such as canagliflozin, empagliflozin or dapagliflozin; Thiazolidinediones (TZDs) such as pioglitazone; FXR agonists such as obeticholic acid (OCA) and any pharmacologically active weight-loss medications such as lorcaserin prior to 6 weeks of screening visit and up to end of study visit
- •- eGFR * 45ml/min/1.73m2 based on MDRD equation
- •- Patients on treatment with the following medicines unless they are on a constant dose for *3 months before randomization: anti-diabetic medications, insulin (if *25% change in dose),
- •beta-blockers, thiazide diuretics, fibrates, statins, niacin, ezetimibe, vitamin E (if doses > 400 IU/day; doses > 800 IU/day are prohibited), thyroid hormone, psychotropic medications, estrogen or estrogen containing birth control
- •- 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)
- •- Presence of cirrhosis on liver biopsy or clinical diagnosis of cirrhosis
- •- Type I diabetes and uncontrolled diabetes defined as HbAlc > 10 % within 60 days prior to enrollment
- •- Patients with contraindications to MRI imaging
- •- For those patients that have had a previous liver biopsy:
- •Significant weight loss (>15%) or change in clinical status (in the opinion of the investigator) since the diagnostic liver biopsy to screening
- •- History or presence of other concomitant liver diseases
- •- Clinical evidence of hepatic decompensation or severe liver impairment
- •- 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
- •- History of inflammatory bowel disease
- •- History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
- •- History of ketoacidosis, lactic acidosis, or hyperosmolar coma OR if occurring between Screening Visit and Randomization Visit.
- •- History of lower limb amputation (including toe amputation) OR if occurring between Screening Visit and Randomization Visit.
研究者
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