Clinical study to assess the effect of a 6-week Elafibranor (120mg) treatment administered once daily on liver fat composition in subjects with Nonalcoholic Fatty Liver (NAFL).
- Conditions
- Subjects with Nonalcoholic Fatty Liver (NAFL)MedDRA version: 22.0Level: LLTClassification code 10029530Term: Non-alcoholic fatty liverSystem Organ Class: 100000004871Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2019-000645-12-NL
- Lead Sponsor
- GENFIT SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 16
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 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
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
20. Subjects who cannot be contacted in case of emergency
In addition to the above criteria, subject should not present any of the following biological exclusion criteria:
21. Positive anti-human immunodeficiency virus (HIV) antibody
22. Positive hepatitis B surface antigen
23. Positive hepatitis C Virus (HCV) antibody
24. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >5 x upper limit of normal (ULN)
25. Conjugated bilirubin > 1.50
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method