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).
- Conditions
- fatty liverNon-alcoholic fatty liver1001965410000546
- Registration Number
- NL-OMON47978
- Lead Sponsor
- GENFIT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- 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 (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.
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 surfac
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint:<br /><br>* Relative amount of saturated fatty acids in the liver (%SFA) measured by<br /><br>1H-MRS at the end of 6 weeks treatment periods.</p><br>
- Secondary Outcome Measures
Name Time Method