Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT03053063) looked at a drug called SEL (selonsertib) in people with a liver condition called NASH (non-alcoholic steatohepatitis) — a form of liver disease where fat, inflammation, and scarring build up in the liver. The trial had two phases: a randomised phase in which 355 people received SEL 18 mg, 354 received SEL 6 mg, and 174 received a placebo (a dummy treatment with no active ingredient); and a smaller open-label phase involving 23 participants who all received SEL 18 mg. The trial was primarily measuring whether the treatment reduced liver scarring (called fibrosis) without making the liver inflammation worse, and — over a longer timeframe of about four and a half years — whether it reduced serious liver-related events such as liver failure, transplant, or death. The reported data shows the following numbers for the main outcome measured at around one year (Week 48): 14.4% of participants in the SEL 18 mg group, 12.8% in the SEL 6 mg group, and 12.8% in the placebo group showed at least a one-stage improvement in liver scarring without their inflammation getting worse. For a related measure — improvement in scarring alone, without the inflammation condition — the reported figures at Week 48 were 18.9% (SEL 18 mg), 16.8% (SEL 6 mg), and 15.7% (placebo). For a measure called "NASH resolution" (meaning both inflammation and cell damage in the liver reached low levels) at Week 48, the reported figures were 2.3% (SEL 18 mg), 3.7% (SEL 6 mg), and 4.1% (placebo). The reported data shows that several other planned outcomes — including the longer-term (Week 240) measures of scarring improvement, NASH resolution, and the rate of serious liver events — were not reported in the submitted results on ClinicalTrials.gov, so those figures are not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 31271665) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Non-Alcoholic Fatty Liver Disease Trial, Terminated
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- A liver biopsy has confirmed you have NASH (a type of fatty liver disease) with advanced scarring (the most severe stage, called F4 or cirrhosis), as reviewed by a specialist reader.
- Your liver enzyme levels (ALT) are not extremely elevated — specifically, no more than 8 times the upper limit of the normal range.
- Your kidneys are working well enough, with a kidney function score of at least 30 mL/min (calculated using a standard formula).
- Your blood sugar control measure (HbA1c) is 9.5% or below — or an alternative sugar test (fructosamine) is 381 or below if the HbA1c test cannot be used.
- Your blood clotting score (INR) is 1.4 or below, unless you are on blood-thinning medication prescribed by a doctor.
- Your platelet count (cells that help blood clot) is at least 100,000 per microliter of blood.
Who may not be able to join:
- You have previously had serious liver complications such as fluid buildup in the abdomen (ascites), confusion caused by liver failure (hepatic encephalopathy), or bleeding from swollen veins in the food pipe or stomach.
- Your liver disease severity score (Child-Pugh score) is above 7, unless this is caused by being on blood-thinning medication.
- Your liver disease severity score (MELD score) is above 12, unless this is caused by being on blood-thinning medication.
- Your liver disease is caused by something other than NASH, such as alcohol, hepatitis B or C, autoimmune conditions, certain medications, or inherited conditions like Wilson disease (confirm with trial site for the full list).
- You have previously had a liver transplant.
- You have been diagnosed with liver cancer (hepatocellular carcinoma), either now or in the past.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Gilead Study Director, Gilead Sciences
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
13 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH; Event-Free Survival (EFS) at Week 240 as Assessed by Time to First Clinical Event
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.