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Non-Alcoholic Fatty LiverPhase 2NCT03953456

Study to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL)

A Phase 2 study testing elafibranor 120mg in people with Non-Alcoholic Fatty Liver, run by Genfit at 1 site in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This randomized, double-blind, cross-over (placebo or elafibranor [GFT505]) placebo-controlled study, will evaluate the effect on hepatic lipid composition and safety of elafibranor 120 mg quaque die (QD) versus placebo in an adult NAFL population after 6 weeks of treatment with a 4-week wash-out period. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Non-Alcoholic Fatty Liver
What is being tested?
elafibranor 120mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
17 participants
Where
1 siteNetherlands
Study dates
16 Aug 2019to 14 Jul 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
  • Must provide signed written informed consent and agrees to comply with the study protocol.
  • Liver fat percentage ≥ 5 percent (as measured with Magnetic Resonance Spectroscopy)
  • 25.0 ≤ BMI ≤ 38.0 kg/m^2
  • Stable dietary habits and physical activity pattern (over 3 months prior to Screening Visit)
  • 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.

Who cannot join

  • Medical history:
  • Documented weight loss of more than 5 percent during the 6-month period prior to Screening Visit
  • Contra-indications for magnetic resonance imaging / spectroscopy
  • Known history of Type 1 and 2 diabetes
  • Known chronic heart failure (Grade I to IV of New York Heart Association classification)
  • 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)
Show all 34Show fewer
  • Uncontrolled hypertension despite optimal antihypertensive therapy
  • Other well documented causes of chronic liver disease according to standard diagnostic procedures.
  • Symptoms of clinical depression
  • 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
  • Known hypersensitivity to the investigation product or any of its formulation excipients
  • Concomitant medications and lifestyle:
  • 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
  • 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
  • Subjects receiving thiazolidinediones (glitazones [pioglitazone, rosiglitazone])
  • 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
  • Any medication use known to interfere with glucose homeostasis/metabolism
  • Smoking
  • 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
  • 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
  • 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
  • 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:
  • Positive anti-human immunodeficiency virus (HIV) antibody
  • Positive hepatitis B surface antigen
  • Positive hepatitis C Virus (HCV) antibody
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >5 x upper limit of normal (ULN)
  • Conjugated bilirubin > 1.50mg/dL due to altered hepatic function Note: Gilbert Disease subjects are allowed into the study
  • International normalized ratio >1.40 due to altered hepatic function
  • Platelet count <100,000/mm^3 due to portal hypertension
  • Serum creatinine levels >1.53 mg/dL in males and >1.24 mg/dL in females
  • Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as subjects with markers of kidney damage or estimated glomerular filtration rate (eGFR) of less than 60 ml/min/1.73 m^2)
  • Unexplained serum creatine phosphokinase (CPK) >2 x ULN. In case of explained elevated CPK >2 x ULN, the measurement can be repeated prior to Randomization. In this case, retest should be performed within 1 to 2 weeks after initial test. A CPK retest >2 x ULN leads to exclusion
  • Hemoglobin A1c (HbA1C) > 6.4% and/or fasting plasma glucose (FGP) > 126 mg/dl

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • NUTRIM School of Nutrition and Translational Research in Metabolism

    Maastricht

Other trials in Netherlands

About this study

Official title: 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)

This randomized, double-blind, cross-over (placebo or elafibranor [GFT505]) placebo-controlled study, will evaluate the effect on hepatic lipid composition and safety of elafibranor 120 mg quaque die (QD) versus placebo in an adult NAFL population after 6 weeks of treatment with a 4-week wash-out period. This study will achieve mechanistic information about the mode of action of Elafibranor on the (lipid) metabolism in the human fatty liver

Being tested
elafibranor 120mg, Placebo
Keywords
Hepatic lipid composition, Elafibranor, Hepatic Glucose Production
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • elafibranor 120mgDrug

    Also called GFT505

    elafibranor 120mg is a coated tablet for oral administration, once daily

  • PlaceboDrug

    Placebo is a coated tablet for oral administration, once daily

Study groups in NCT03953456
Study groupRoleWhat they receive
elafibranor 120mg followed by placeboExperimentalParticipants will first receive elafibranor 120mg for 6 weeks. After a washout period of 4-6 weeks, they will then receive placebo for 6 weeks
Receives: Drug: elafibranor 120mg; Drug: Placebo
placebo followed by elafibranor 120mgPlacebo comparatorParticipants will first receive placebo for 6 weeks. After a washout period of 4-6 weeks, they will then receive elafibranor 120mg for 6 weeks
Receives: Drug: elafibranor 120mg; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in relative amount of saturated fatty acids in the liver

    Relative amount of saturated fatty acids (SFA) in the liver measured by Magnetic Resonance Spectroscopy (1H-MRS) at the end of 6 weeks treatment period

    Measured: After 6 weeks

Secondary outcomes (32)

  1. Change in hepatic insulin sensitivity

    Hepatic insulin sensitivity measured by Hepatic Glucose Production (HGP) at the end of 6 weeks treatment period

    Measured: After 6 weeks

  2. Glucose homeostasis markers

    Fasting glycemia

    Measured: After 6 weeks

  3. Glucose homeostasis markers

    HbA1c

    Measured: After 6 weeks

  4. Glucose homeostasis markers

    Fasting insulinemia

    Measured: After 6 weeks

  5. Glucose homeostasis markers

    C-peptide

    Measured: After 6 weeks

  6. Glucose homeostasis markers

    Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index

    Measured: After 6 weeks

  7. Glucose homeostasis markers

    Fructosamine

    Measured: After 6 weeks

  8. Lipid metabolism markers

    Triglycerides (TG)

    Measured: After 6 weeks

  9. Lipid metabolism markers

    Total cholesterol (TC)

    Measured: After 6 weeks

  10. Lipid metabolism markers

    High density lipoprotein-cholesterol (HDL-C)

    Measured: After 6 weeks

  11. Lipid metabolism markers

    Low density lipoprotein-cholesterol (LDL-C)

    Measured: After 6 weeks

  12. Lipid metabolism markers

    Non-HDL-C

    Measured: After 6 weeks

  13. Lipid metabolism markers

    Free fatty acid (FFA)

    Measured: After 6 weeks

  14. Inflammatory markers

    High sensitivity C-reactive protein (hs-CRP)

    Measured: After 6 weeks

  15. Inflammatory markers

    Fibrinogen

    Measured: After 6 weeks

  16. Inflammatory markers

    Haptoglobin

    Measured: After 6 weeks

  17. Liver function

    Alanine aminotransferase (ALT)

    Measured: After 6 weeks

  18. Liver function

    Aspartate aminotransferase (AST)

    Measured: After 6 weeks

  19. Liver function

    Gamma glutamyl transferase (GGT)

    Measured: After 6 weeks

  20. Liver function

    Alkaline phosphatase (ALP)

    Measured: After 6 weeks

  21. Liver function

    Total and conjugated bilirubin

    Measured: After 6 weeks

  22. Renal function

    Creatinine

    Measured: After 6 weeks

  23. Renal function

    Estimated glomerular filtration rate (using Modification of Diet in Renal Disease (MDRD) formula)

    Measured: After 6 weeks

  24. Renal function

    Blood urea nitrogen

    Measured: After 6 weeks

  25. Renal function

    Albumin

    Measured: After 6 weeks

  26. Renal function

    Uric acid

    Measured: After 6 weeks

  27. Renal function

    Total proteins

    Measured: After 6 weeks

  28. Body weight

    Measured: After 6 weeks

  29. Body Mass Index

    Measured: After 6 weeks

  30. Waist circumference

    Measured: After 6 weeks

  31. Incidence and severity of treatment emergent adverse events (TEAEs) and their relationship to study drug

    Measured: After 6 weeks

  32. Incidence of clinically meaningful changes from baseline in safety laboratory parameters, and vital signs

    Measured: After 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2019
  2. Study start16 Aug 2019
  3. Primary completion11 Mar 2020
  4. Study completion14 Jul 2020

Why it stopped: Continuation of the trial cannot serve a scientific purpose

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized, double-blind, cross-over (placebo or elafibranor \[GFT505\]) placebo-controlled study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03953456
Sponsor's protocol ID
GFT505-219-8
Other IDs
2019-000645-12, 2019
Status last verified
Aug 2020
First submitted
15 May 2019
Last updated
31 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing elafibranor 120mg in people with Non-Alcoholic Fatty Liver, run by Genfit at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Continuation of the trial cannot serve a scientific purpose). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in relative amount of saturated fatty acids in the liver (time frame: After 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03953456.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2020.

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