A Phase 2, Multicenter, Placebo-Controlled, Randomized, Double-Blind, 48-Week Study to Evaluate the Efficacy and Safety of Combination Therapy of K-877-ER and CSG452 in Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH) with Liver Fibrosis
This clinical trial is testing a new combination treatment for adults with non-alcoholic steatohepatitis (NASH). NASH is a condition where build-up of fat in the liver causes swelling, cell injury, and scarring (known as fibrosis). Researchers are investigating whether taking two tablets—pemafibrate and tofogliflozin—together can calm liver inflammation and stop scarring from worsening. Over 48 weeks, participants will receive either the active combination medicine or a dummy pill (placebo). Because this is a double-blind study, neither the doctor nor the patient will know which treatment is given. Doctors will track progress using small liver tissue samples (biopsies) taken at the start and end of the 48-week period. The trial hopes to find out if this treatment is safe and effective, potentially offering a new way to protect the liver before permanent damage occurs.
At a glance
What is this study about?
Fatty liver disease happens when extra fat builds up inside liver cells. In some people, this fat causes the liver to swell and become irritated, a condition known as non-alcoholic steatohepatitis, or NASH. Over time, ongoing swelling can lead to stiff scar tissue forming in the liver, called fibrosis. If fibrosis continues to worsen, it can eventually lead to cirrhosis, where the liver struggles to work properly. This study focuses on people who have NASH and scarring, but have not yet developed cirrhosis.
Currently, doctors and researchers are searching for effective medicines to help reverse liver damage and calm inflammation. This Phase 2 study is exploring a treatment that combines two different medicines: pemafibrate and tofogliflozin. Pemafibrate is designed to help balance blood fats and ease swelling, while tofogliflozin is a medicine that helps the body remove excess sugar through the urine. Researchers believe using both together may give the liver a better chance to heal than standard approaches.
The trial will last for 48 weeks. During this time, participants will be randomly chosen to take either the study medicines or inactive dummy pills (placebos). Doctors will carefully monitor everyone's health and look at tiny samples of liver tissue, called biopsies, taken before and after treatment. They want to check if the swelling has improved by at least two points on a standard medical scale without the scarring getting any worse.
Finding a successful treatment for NASH is vital because there are currently limited approved medicines for this condition. If this combination works well, it could help people protect their liver health and lower the chances of developing serious liver failure in the future.
Key takeaways
- Tests a combination of two medicines (pemafibrate and tofogliflozin) for NASH with liver scarring.
- Aimed at adults who have liver fibrosis but have not developed cirrhosis.
- Lasts for 48 weeks and compares the active combination against a dummy pill (placebo).
- Requires liver biopsies at the start and end of the study to measure healing.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is open to adults aged 18 and older of any sex who have been diagnosed with non-alcoholic steatohepatitis (NASH) alongside liver scarring (fibrosis).
To be suitable, the scarring must not have progressed to cirrhosis, which is late-stage, permanent liver hardening. Participants must also have had a recent liver biopsy (usually within the past 24 weeks) or be willing to have one done at the start of the study to confirm the diagnosis.
People with other types of liver conditions, such as viral hepatitis, or those with very advanced liver disease may not be able to join. Your study doctor will carry out detailed health checks and blood tests to make sure taking part is completely safe for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with fatty liver disease or NASH.
- I have some liver scarring (fibrosis) but do not have cirrhosis.
- I am willing to take daily tablets and attend regular hospital check-ups for 48 weeks.
- I am comfortable having liver biopsies to assess my liver health.
What does participation involve?
Taking part in this trial lasts for around 48 weeks (just under one year). Participants will be asked to take study tablets every day as instructed by the research team. You will have regular appointments at a hospital or clinical trial clinic so the medical team can check your overall health. These visits will include physical examinations, blood tests, urine checks, and discussions about how you are feeling. A key part of the study involves having a liver biopsy (a minor procedure using a thin needle to take a tiny sample of liver tissue) at the start and at week 48, so doctors can see if the liver tissue has improved.
Potential risks and benefits
Locations (2)
- —UnverifiedSpain
- —UnverifiedBulgaria
Common questions
What is the difference between simple fatty liver and NASH?
Simple fatty liver means there is extra fat in the liver cells, but usually little to no swelling. NASH means the fat has started causing inflammation, cell damage, and scarring.
Why is a liver biopsy required?
A biopsy allows doctors to look directly at liver cells under a microscope. It is currently the most accurate way to check how much inflammation and scarring is present.
What is a placebo?
A placebo is a dummy pill that looks identical to the real medicine but contains no active ingredients. It helps researchers prove whether changes are truly caused by the study drug.
Will I have to pay for any of the treatment or tests?
No, all study-related medicines, tests, and doctor visits are provided free of charge, and some travel expenses may also be reimbursed.
Can I leave the study if I change my mind?
Yes, taking part is completely voluntary. You can withdraw your consent and leave the study at any point, and your standard healthcare will continue as normal.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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