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 involved 27 participants in a primary treatment phase, of whom 25 completed that phase. A further 21 participants then entered a longer follow-up stage (called the Long-term Safety Extension Phase), with 15 of those completing it. The trial was measuring changes in HDL cholesterol — often called "good cholesterol" — looking specifically at its concentration (amount in the blood), the size of HDL particles, and the number of HDL particles, all before and after treatment. The reported data shows that by the end of the primary treatment phase, the average change in HDL cholesterol concentration from the starting point was −0.38 mmol/L (millimoles per litre, a standard unit for measuring substances in blood), meaning it was lower than at the start. The average change in HDL particle size was −0.44 nm (nanometres), and the average change in HDL particle number was −0.06 µmol/L. For the secondary measurements taken at weeks 4, 8, and 12, the reported data shows the HDL cholesterol concentration changed by approximately −0.21, −0.31, and +0.05 mmol/L respectively at those three time points. HDL particle size changed by −0.30, −0.30, and 0.00 nm, while HDL particle number changed by +0.55, +0.60, and +1.60 µmol/L at those same time points. It is worth noting that the reported data does not include a comparison group (for example, a placebo group), so these numbers reflect changes within the one group of participants only. No comparative figures were reported for the Long-term Safety Extension Phase outcomes in the data submitted. 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 ↗
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 Primary Biliary Cholangitis 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 have been diagnosed with, or are likely to have, a liver condition called Primary Biliary Cholangitis (PBC), confirmed by at least 2 of these 3 things: abnormal liver enzyme levels in blood tests for at least 6 months, a positive result on a specific blood antibody test, or a liver biopsy that shows signs of PBC.
- You have been taking a medication called UDCA (ursodeoxycholic acid) for at least 12 months at a stable dose for the last 3 months, OR you were unable to tolerate UDCA and have not taken it for at least 3 months before the trial starts.
- If you are a woman who could become pregnant, you must be willing to use at least one highly effective form of birth control during the trial and for at least 30 days after your last dose of the trial medication; women who are past menopause or have had surgery to prevent pregnancy also qualify.
- You are willing to sign a consent form and agree to follow the trial rules and schedule.
Who may not be able to join:
- Your PBC has reached an advanced or severe stage (sometimes called "decompensated"), as decided by the trial doctor.
- You have severe itching, or have taken certain medications to treat itching (such as bile acid sequestrants or rifampicin) within the 2 months before the trial starts.
- You have, or have had, another significant liver disease, such as active Hepatitis B or C, primary sclerosing cholangitis, alcohol-related liver disease, autoimmune liver disease, or a condition called nonalcoholic steatohepatitis (confirm with trial site if unsure whether your history applies).
- You have diabetes or another medical condition that is not well controlled or stable, which might affect the trial results.
- You have taken certain medications too recently before the trial, including: cholesterol-lowering drugs or omega-3 supplements (within 28 days), certain lipid-lowering agents or Vitamin E supplements (within 3 months), certain immune-suppressing or liver-affecting drugs (within 6 months), or certain immune-therapy drugs targeting specific proteins in the body (within 12 months) — confirm the full list of restricted medications with the trial site.
- You are planning to make significant changes to your diet or exercise routine during the trial.
- You have a significant heart rhythm problem that could make participation unsafe.
- You are pregnant, have tested positive for pregnancy, or are currently breastfeeding.
- You have taken part in another clinical trial involving the drug OCA in the last 3 months, or any other investigational trial in the last 30 days before the trial starts.
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.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Absolute Change From Baseline In High-density Lipoprotein (HDL) Cholesterol Concentration; Absolute Change From Baseline In HDL Particle Size; Absolute Change From Baseline In HDL Particle Number
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.