IVA337 for Fatty Liver

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Pinnacle Research Group, Anniston, AL
Fatty Liver+4 More
IVA337 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called lanifibranor can improve liver health in people with nonalcoholic steatohepatitis.

See full description

Eligible Conditions

  • Fatty Liver
  • Non Alcoholic Steatohepatitis (NASH)

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether IVA337 will improve 3 primary outcomes in patients with Fatty Liver. Measurement will happen over the course of Date of randomisation until the date of biopsy at Week 72.

Week 72
Resolution of NASH
Week 72
Resolution of NASH and improvement of fibrosis
Year 7
Time to first clinical outcome event

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

3 Treatment Groups

Lanifibranor (IVA 337) (1200 mg/day)
1 of 3
Lanifibranor (IVA 337) (800 mg/day)
1 of 3
Matching placebo
1 of 3
Experimental Treatment
Non-Treatment Group

This trial requires 2000 total participants across 3 different treatment groups

This trial involves 3 different treatments. IVA337 is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Lanifibranor (IVA 337) (1200 mg/day)
Drug
3 Lanifibranor tablets 400mg with food --> once a day (quaque die, QD)
Lanifibranor (IVA 337) (800 mg/day)2 Lanifibranor tablets 400mg + 1 Placebo to match tablet with food --> once a day (quaque die, QD)
Matching placebo
Drug
3 Placebo to match tablets with food --> once a day (quaque die, QD)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lanifibranor
Not yet FDA approved
Placebo
1995
Completed Phase 3
~2810

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: part 2: date of randomisation until the end of study (eos) date approximately 7 years after first patient randomized
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly part 2: date of randomisation until the end of study (eos) date approximately 7 years after first patient randomized for reporting.

Closest Location

Pinnacle Research Group - Anniston, AL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male or female, aged ≥18 years at the time of signing informed consent
Steatosis score ≥1
Activity score: A3 or A4
Fibrosis score: F2 or F3
Antidiabetic treatment if glucagon-like peptide-1 receptor agonists (GLP1 receptor agonists) or sodium-glucose co-transporter-2 inhibitors (SGLT2 inhibitors): Stable dose for at least 3 months
Vitamin E (if at a dose ≥400 IU/day): Stable dose for at least 6 months
Statins: Stable dose for at least 3 months
All other chronically administered drugs must be stable for at least 3 months prior to Screening
Weight stable for 6 months prior to Screening and between the qualifying liver biopsy and Baseline (no more than 5% change for both periods)
Negative serum pregnancy test at study Screening for females of childbearing potential confirmed by central laboratory. Females of childbearing potential must practice a consistent and proper use of highly effective method of contraception throughout the study and for 1 month after treatment discontinuation.

Patient Q&A Section

Can fibrosis be cured?

"In this small observational study, no effect of an experimental agent was seen for either of the two endpoints of cirrhosis and non-cirrhotic liver. Although this study was not powered to exclude clinically significant benefits and thus is only intended as a preliminary study, this lends weight to the belief that the liver does not remodel. A larger, longer-term trial is necessary to examine these issues further." - Anonymous Online Contributor

Unverified Answer

What is fibrosis?

"Fibrosis, a non-specific term for fibrotic tissue, describes an abnormal tissue response of the body to injury, such as inflammation or infection. The term fibrosis can refer to many different diseases and conditions such as lung fibrosis, liver fibrosis, and heart fibrosis, which causes abnormal cell growth, cell function, or the formation of scarring, in response to long-term or repeated overuse.\n" - Anonymous Online Contributor

Unverified Answer

What causes fibrosis?

"Fibrosis may develop in several joints, but the main cause is unknown. There is evidence that fibrosis may be associated in some ways with genetics, smoking and with the use or clearance (or lack of) drugs, and with physical trauma or injury. Fibroses may also develop as a result of aging and the depletion of other tissues and organs." - Anonymous Online Contributor

Unverified Answer

What are common treatments for fibrosis?

"Fibrosis is an age-dependent disease. The majority of cases present as part of either interstitial lung disease or pulmonary hypertension. Fibrogenic conditions account for approximately 10% of cases of lung transplantation. The main treatments include corticosteroids plus azathioprine plus other immunosuppressive therapies. Bronchitis (a common feature of some patients with fibrosis) is treated with azithromycin. There is some doubt regarding whether there are definitive treatments for fibrosis. This is particularly so in patients who present with chronic symptoms. [Find some common treatments for fibrosis through Power." - Anonymous Online Contributor

Unverified Answer

What are the signs of fibrosis?

"Fibrosis involves different tissues in the body, such as tissues in the skin. The most commonly involved lesions involve the lungs, liver, pancreas, and kidneys.\n\nThe initial observation in a number of cases have identified an association of fibrotic changes with the presence of systemic disease. In one case, a patient with no history of systemic disease was found to have fibrosis involving the lungs. Furthermore, in another case of suspected coexisting systemic disease, a review of a biopsy of the liver demonstrated the presence of fibrosis.\n\nThere is still much debate in the field with respect to the underlying cause of fibrosis. Although no clear associations have been established, multiple theories exist." - Anonymous Online Contributor

Unverified Answer

How many people get fibrosis a year in the United States?

"The prevalence of fibrosis is increasing in the US, with rates varying widely among racial groups. As we move forward to reduce the burden of chronic kidney disease associated with hypertension in the US through the National Action Program on Chronic Kidney Disease, it is critical that the number of people with fibrosis be accurately characterized in order to achieve maximal outcomes." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating fibrosis?

"It would seem that at this time there are no treatments available that would improve the condition of the patients that have fibrosis. With regard to the new compounds that are being developed that are being studied, it may take many years before the drugs have been approved by the FDA. Although there are some new innovations in medical treatment, this has not come to fruition yet and for the present and for the foreseeable future, it would seem that patients with fibrosis should still be evaluated by a specialist to see if they would be suitable candidates for any of these new compounds." - Anonymous Online Contributor

Unverified Answer

How serious can fibrosis be?

"There is a tremendous variability of fibroid size and degree, but there is no reliable correlation between the size and degree of fibrous tissue within the fibromatosis, the extent of the underlying disease, and the clinical severity of symptoms." - Anonymous Online Contributor

Unverified Answer

What does iva337 usually treat?

"Treatment is mainly used to control pain. There is no treatment for the underlying condition, but there is a large number of trials investigating treatments for other fibrotic conditions. There is limited literature detailing the treatment for other conditions. At present, the main focus of fibrosis clinics is treatment of the symptoms or symptoms, which tend to be non-specific, and hence it is difficult to discriminate treatment in fibrosis." - Anonymous Online Contributor

Unverified Answer

Is iva337 typically used in combination with any other treatments?

"Fibrin glue seems to be more appropriately used with surgery than with other treatments, particularly in combination with other treatment approaches. Randomized controlled trials of fibrin glue combined with other treatments for endoscopic pleurodesis are needed to determine the ideal combination of fibrin glue with other treatments and to determine whether this combination has any advantage over other therapies for this indication. Similarly, it is important to determine whether fibrin glue is preferable to a variety of other sclerosing agents in combination with surgery." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets fibrosis?

"Recent findings reports the highest frequency of abnormal fibrosis reported to date. The findings suggest that, to be more effective, screening programs need to be implemented in populations exposed to the same environmental risk factors as those studied in this study. Prospective studies are warranted to validate these findings and further explore their impact on clinical practice." - Anonymous Online Contributor

Unverified Answer

Has iva337 proven to be more effective than a placebo?

"While most studies using iva337 have a long track record, these patients received placebo. Results from a recent paper of one of the longest studies using iva337 (4 years) indicate that iva337 is highly effective in the relief of symptoms. The duration of the study did not appear to influence treatment outcomes. The improvement of symptoms of RA does not happen during a short period of time, but persists during the long term." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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