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 (NCT02217475) enrolled 289 adults with a liver condition called non-alcoholic steatohepatitis (NASH) — a form of liver disease involving fat build-up, inflammation, and cell damage. Participants were divided into three groups: one group received a dummy pill (placebo) for both years of the study, a second group received the placebo in year one and then switched to the study drug cenicriviroc (CVC) 150 mg in year two, and a third group received CVC 150 mg for both years. The trial used liver biopsies (small tissue samples taken from the liver) to look at changes in disease activity and scarring (fibrosis) over one and two years. The reported data shows that for the main (primary) outcome at the end of year one — a meaningful improvement in a liver disease activity score without the liver scarring getting worse — 27 out of the placebo group and 23 out of the CVC group met that measure. For several secondary outcomes, the reported data shows: at year one, 15 placebo participants and 29 CVC participants showed at least a one-stage improvement in liver scarring without their liver inflammation getting worse; 8 placebo and 11 CVC participants had complete resolution of the active inflammation without scarring worsening; and 4 placebo versus 7 CVC participants met both the resolution of inflammation and at least a one-stage improvement in scarring. At year two, the reported numbers for complete resolution of inflammation without scarring worsening were 3 (placebo) and 11 (CVC), and for both resolution and scarring improvement, 2 (placebo) and 5 (CVC). 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 34951993) ↗
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 2 Non-Alcoholic Fatty Liver Disease Trial, Completed
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 are between 18 and 75 years old
- A liver biopsy has confirmed you have a liver condition called NASH (a form of fatty liver disease), with a disease activity score of 4 or higher, with points scored in each part of the scoring system
- Your biopsy also shows some scarring (fibrosis) in the liver, rated at stage 1, 2, or 3 out of 4
- You meet at least one of these three conditions: (a) you have been diagnosed with type 2 diabetes; (b) you have a body mass index (BMI) over 25 and also have at least one sign of metabolic syndrome, such as a large waist, high triglycerides, low "good" cholesterol, high blood pressure, or high fasting blood sugar; or (c) your biopsy shows advanced scarring (stage 3) and/or a NASH activity score of 5 or higher
- You are willing to have three liver biopsies during the study — one at the start, one at one year, and one at two years
- Your liver enzyme levels (AST and ALT) are not more than five times the upper end of the normal range
Who may not be able to join:
- You have tested positive for the hepatitis B virus
- You have tested positive for hepatitis C antibodies, unless you were successfully treated for hepatitis C at least one year ago, or your body cleared the virus on its own without treatment (confirm with trial site)
- You have previously had a liver transplant, or one is planned for you
- You have another known cause of long-term liver disease, including liver damage caused by alcohol
- You have a history of advanced liver scarring (cirrhosis) or serious liver complications such as fluid build-up in the abdomen, confusion caused by liver failure, or bleeding from swollen veins in the food pipe
- You drink more than 21 units of alcohol per week (if male) or more than 14 units per week (if female) — one unit equals roughly half a pint of beer, a small glass of wine, or a single measure of spirits
- You are living with HIV (type 1 or 2)
- You have had weight-loss surgery such as gastric banding or bypass in the past 5 years, or you are planning to have it during the study
- You are currently pregnant or breastfeeding
- You have another significant health condition or have received prior treatment that the study doctor believes would make participation unsafe or difficult (confirm with trial site)
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: Eric Lefebvre, MD, Allergan
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
8 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participant With Hepatic Histological Improvement in NAS by ≥ 2 Points With at Least 1-Point Reduction in Either Lobular Inflammation or Hepatocellular Ballooning and no Concurrent Worsening of Fibrosis at Year 1
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.