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 (NCT03053050) enrolled 808 people across three groups in a randomised phase: 324 received a higher dose of the study drug (selonsertib 18 mg), 323 received a lower dose (selonsertib 6 mg), and 161 received a placebo (an inactive tablet). A further 99 participants entered a separate open-label phase in which everyone received the higher dose. The trial was looking at a liver condition called NASH (non-alcoholic steatohepatitis), specifically whether the study drug could reduce scarring (fibrosis) in the liver, and over the longer term, whether it could delay serious liver-related events such as cirrhosis, liver failure, transplant, or death. The reported data shows that at the 48-week mark, the percentage of participants who showed at least a one-stage improvement in liver scarring without their NASH getting worse was 9.6% in the higher-dose group, 12.1% in the lower-dose group, and 13.2% in the placebo group. For liver scarring improvement alone (without the NASH condition), the figures were 12.7%, 13.7%, and 16.4% respectively. The reported data also shows that the percentage of participants whose scarring progressed to the most severe stage (cirrhosis) by week 48 was 13.0% in the higher-dose group, 15.6% in the lower-dose group, and 15.7% in the placebo group. Results for the longer-term outcomes measured at week 240 — including survival free from serious liver events and scarring improvement — were not reported in the data submitted to ClinicalTrials.gov. 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:
- You have had a liver biopsy that shows a specific type of liver scarring related to a condition called NASH (fatty liver disease with inflammation), at a stage called "bridging fibrosis" (F3)
- Your liver enzyme levels (ALT) are not too high — no more than 8 times the upper end of the normal range
- Your kidneys are working well enough, with a filtration rate of at least 30 mL/min (confirm with trial site)
- Your blood sugar control, as measured by a test called HbA1c, is at 9.5% or below (or an alternative measure called fructosamine is within an acceptable range if the HbA1c test cannot be used)
- Your bilirubin level (a substance measured in blood that relates to liver function) is within an acceptable range, unless you have a known condition like Gilbert's syndrome that explains a higher level
Who may not be able to join:
- You have previously had serious liver complications such as fluid build-up in the abdomen, liver-related confusion or brain problems, or bleeding from swollen veins in the digestive tract
- Your liver disease is assessed as being at a more severe stage based on standard scoring systems used by doctors (confirm with trial site)
- Your liver has another cause of damage, such as heavy alcohol use, hepatitis B or C, an autoimmune condition, medication-related damage, Wilson's disease, iron overload, or a genetic condition called alpha-1-antitrypsin deficiency
- You have previously had a liver transplant
- You have been diagnosed with, or have a history of, liver cancer
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
10 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH at Week 48; 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: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.