CTRI/2022/04/041926已完成2 期
A Randomized, Multicenter, Double-blinded, Parallel-group, Phase 2 Study to Evaluate Efficacy and Safety of Livitol among Patients with Moderate to Severe Non-alcoholic fatty liver [steatosis].
Dr Reddys Laboratories9 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2022年5月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 9
- 主要终点
- Hepatic Fat content
研究概览
简要总结
This is a randomized, prospective, multicentre,double-blind, placebo-controlled, parallel group Phase 2 study to assessefficacy and safety of Livitol among patients with moderate to severe non-alcoholicfatty liver (steatosis).
The study includes screening period (14 days) andtreatment period (24 weeks).
The study will include approximately 76 participantsat approximately 8-10 centres in India.
Prospective subjects who have ultrasonography reportconfirming moderate to severe non-alcoholic fatty liver (steatosis) will be consideredfor 14-day screening period to confirm the study eligibility. Ultrasonographypositive for moderate to severe fatty liver) is required prior to the baselineMRI-PDFF. The eligible subjects will be randomized (1:1) to receive study drug(Livitol) or placebo, and the treatment will be administered twice daily forthe duration of 24 weeks (6 months). The subjects will be evaluated at Week 4, 12and 24.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18-65 years at study entry.
- •Male, or female diagnosed with non-alcoholic fatty liver (steatosis), but if female, meets all the following criteria: a.
- •Not breastfeeding b.
- •Post-menopausal or negative urine pregnancy test result at Screening /Visit 1 (not required for hysterectomized females).
- •If of childbearing potential (including peri-menopausal women who have had a menstrual period within one year) must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as double barrier methods [male condom with spermicide, with or without cervical cap or diaphragm], implants, injectables, oral contraceptives [must have been using for at least the last 3 months], some intrauterine contraceptive devices, tubal ligation, or in an established relationship with a vasectomized partner) during the entire duration of the study.
- •Patients diagnosed with moderate to severe fatty liver based on ultrasound (if ultrasound is available within 3 months of screening, it would be considered valid for screening).
- •Patients with liver fat greater than 15% as measured by MRI-PDFF at Screening.
- •Can read, understand, and sign the informed consent form (ICF) and communicate with the investigator, and understand and comply with protocol requirements.
排除标准
- •eGFR less than 60ml/min/1.73m2 at screening (chronic kidney disease epidemiology collaboration [CKD-EPI] formula).
- •Elevation of AST or ALT greater than five times upper limit normal (ULN).
- •Evidence of significant alcohol consumption (defined as more than 7 drinks/week for females and greater than 14 drinks/week for males) within 6 months prior to randomization
- •Body Mass Index (BMI) more than or equal to 40 kg/m2
- •Use of any of the following medications in the last 12 weeks prior to screening visit: a.
- •Metformin greater than 2 g/day b.
- •Insulins – all forms c.
- •Use of sildenafil, tadalafil, vardenafil, pioglitazone, rosiglitazone, alpha blockers, oral nitrates.
- •Medications associated with increased hepatic steatosis.
- •Commonly used medications associated with drug induced hepatic steatosis include amiodarone, valproate, tamoxifen, methotrexate, and some chemotherapeutic and antiretroviral agents, and steroids.
- •Organic Cation Transporter 2/MATE inhibitors (Includes multidrug and toxin extrusion protein 1 and multidrug and toxin extrusion protein 2 inhibitors like: i.
- •Methotrexate ii.
- •Tamoxifen f.
- •Corticosteroids (Nasal steroids are allowed if the subject has been on a stable dose for the past 12 weeks and the dose employed does not exceed the maximal recommended dose) g.
- •Estrogens h.
- •Amiodarone i.
- •Valproic acid j.
- •Coumadin k.
- •Isoniazide l.
- •Nucleoside analogues used for the treatment of human immunodeficiency virus (HIV) infections m.
- •Any dietary supplement including Vitamin E and L-Carnitine other than multi-vitamins.
- •Presence or suspicion of other forms of chronic liver disease (e.g., cirrhosis, autoimmune hepatitis (greater than 1 is to 160 Anti-Nuclear Antibody ANA), Wilsons disease, Hemochromatosis (Ferritin greater than 1000 ug/L and percent iron saturation greater than 45 percent), hepatitis A, B or C), primary biliary cholangitis, primary sclerosing cholangitis, Wilsons disease, homozygous alpha 1 anti trypsin deficiency.
- •Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator, including but not limited to the following conditions: a.
- •Unable to undergo MRI or contraindications for MRI procedure b.
- •Requires anti coagulation therapy d.
- •Gastrointestinal disorders including, but not limited to, the following: pancreatitis, inflammatory bowel disease, or other diseases associated with malabsorption or persistent abdominal discomfort e.
- •Endocrine disorders, other than type 2 diabetes and hypothyroidism on stable replacement therapy for 3 months prior to enrolment.
- •Chronic infection (e.g., tuberculosis, HIV infection, hepatitis A virus, hepatitis B virus, or hepatitis C virus) g.
- •Neurological or psychiatric diseases that preclude valid execution of informed consent or may interfere with the subjects compliance with study procedures (e.g., major depressive disorder within the last 2 years, a history of suicidal behaviour in the last 3 months).
- •This will be based on investigator’s opinion and does not need formal psychological screening.
- •History of other psychiatric disorders including schizophrenia and bipolar disorder only through clinical history and does not require a psychological screening.
- •Participation in a weight loss program within the past 3 months and /or weight change greater than or equal to 5 percent during the past month.
- •History of substance abuse (including alcohol abuse as defined above) in the past 3 months
- •Has received any investigational drug within 3 months of Screening.
- •Has donated blood within 3 months before Screening or is planning to donate blood during the study.
- •Has had a serious acute infection, such as pneumonia in the previous 12 weeks
- •Prior or planned (during the study period) bariatric surgery (e.g., gastroplasty, sleeve gastrectomy and roux-en-Y gastric bypass).
结局指标
主要结局
Hepatic Fat content
时间窗: Baseline, Week 24
次要结局
- 1. To evaluate the change from baseline in fatty liver grading using the 4 ultrasound criteria or signs(2. To evaluate the change in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and)
研究者
研究点 (9)
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