NL-OMON47978已完成2 期
A Double-Blind, Placebo-Controlled, Cross-over Phase II Study to Evaluate the Effect of a 6-week Elafibranor (120mg) treatment administered once daily on hepatic lipid composition in subjects with Nonalcoholic Fatty Liver (NAFL). - The effect of elafibranor on hepatic lipid composition in NAF
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- GENFIT
- 入组人数
- 16
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
- •1. Males or post-menopausal females aged from 40-75 years inclusive at first
- •Screening Visit. (Post-menopausal defined as: subject should be surgically
- •sterilized at least 6 months or no spontaneous menses for at least 1 year prior
- •to screening)
- •2. Must provide signed written informed consent (ICF) and agrees to comply with
- •the study protocol.
- •3. Liver fat percentage IHL * 5% (as measured with 1H-MRS)
- •4. 25.0 * BMI * 38.0 kg/m2
- •5. Stable dietary habits and physical activity pattern (over 3 months prior to
- •Screening Visit)
- •6. Subject agrees not to change dietary habits and physical activity pattern,
- •to follow diet and lifestyle recommendations and not to consume or use illicit
- •drugs during the study up to end of treatment.
排除标准
- •Medical history:
- •1. Documented weight loss of more than 5% during the 6-month period prior to
- •Screening Visit
- •2. Contra-indications for MRI/MRS
- •3. Known history of Type 1 and 2 diabetes
- •4. Known chronic heart failure (Grade I to IV of New York Heart Association
- •classification)
- •5. History of clinically significant acute cardiac event within 6 months prior
- •to Screening Visit such as: stroke, transient ischemic attack, or coronary
- •heart disease (angina pectoris, myocardial infarction, revascularization
- •procedures)
- •6. Uncontrolled hypertension despite optimal antihypertensive therapy
- •7. Other well documented causes of chronic liver disease according to standard
- •diagnostic procedures.
- •8. Symptoms of clinical depression
- •9. Other concurrent medical (e.g., immunological, neoplastic, endocrine,
- •hematological, gastrointestinal or neurological) or psychiatric condition,
- •which, in the opinion of the Investigator, would place the subject at increased
- •risk, preclude obtaining voluntary consent/assent or compliance with required
- •study procedures, or would confound the objectives of study
- •10. Known hypersensitivity to the investigation product or any of its
- •formulation excipients, Concomitant medications and lifestyle:
- •11. Fibrates are not permitted from 8 weeks before Screening up to end of
- •treatment. Subjects taking statins or ezetimibe prior to Screening Visit 1 may
- •participate if the dose has been stable for 3 months prior to Screening Visit 1
- •and no dose adjustments are anticipated
- •12. Currently taking drugs that can induce steatosis/steatohepatitis including,
- •but not restricted to: corticosteroids (parenteral & oral chronic
- •administration only), amiodarone (Cordarone), tamoxifen (Nolvadex), and
- •methotrexate (Rheumatrex, Trexall), which are not permitted 30 days prior to
- •Screening and up to end of treatment
- •13. Subjects receiving thiazoledinediones (glitazones [pioglitazone,
- •rosiglitazone])
- •14. Currently taking any medication that could interfere with study medication
- •absorption, distribution, metabolism, or excretion or could lead to induction
- •or inhibition of microsomal enzymes, e.g., indomethacin, which are not
- •permitted from Randomization until end of treatment
- •15. Any medication use known to interfere with glucose homeostasis/metabolism
- •16. Smoking
- •17. Current or recent history (<5years) of significant alcohol consumption. For
- •men, significant consumption is typically defined as higher than 30 g pure
- •alcohol per day. For women, it is typically defined as higher than 20 g pure
- •alcohol per day
- •18. Subjects who have donated blood or blood products within the previous month
- •prior to screening or who plan to donate blood or blood products at any time
- •during the trial and in the month following the end of the study
- •19. Is participating in any other study and have received any other
- •investigational drug or device within 30 days prior to Screening or are taking
- •part in a non-medication study which, in the opinion of the Investigator, would
- •interfere with study compliance or outcome assessments
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研究者
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