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 (NCT02516605) enrolled 61 people in total across five groups. Four groups received different daily doses of a drug called LJN452 (0.03 mg, 0.06 mg, 0.09 mg, or 0.15 mg once a day), while a fifth group received a placebo (a dummy treatment with no active ingredient). The trial ran for 28 days and measured several things: a liver enzyme in the blood called GGT (gamma-glutamyl transferase, a marker that can reflect liver activity), as well as general body monitoring readings such as blood pressure, pulse rate, body temperature, and heart-related electrical readings (ECGs). Almost all participants who started the trial completed it — only one person in the 0.15 mg group and one in the placebo group did not finish. The reported data shows that for the main liver enzyme measurement (GGT), the numbers are expressed as a "fold change" — meaning how much the level multiplied or shrank compared to where it started, with a value below 1.0 indicating the level was lower at Day 28 than at the beginning. The placebo group had a reported fold change of 0.86, while the four LJN452 dose groups had reported fold changes of 0.74 (0.03 mg), 0.41 (0.06 mg), 0.28 (0.09 mg), and 0.31 (0.15 mg). For the monitoring readings, the reported data shows blood pressure readings across time points ranging roughly from 118 to 132 mmHg across all groups, pulse rates ranging from about 61 to 75 beats per minute, body temperatures all close to 36.4–36.7°C, and ECG heart rate and interval readings that were broadly similar across groups. The data as submitted includes multiple time-point readings for some of these measures, but the trial record does not provide a complete breakdown of which reading belongs to which specific time point for all groups. 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 36267872) ↗
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 must be 18 years of age or older.
- You must have been diagnosed with Primary Biliary Cholangitis (PBC), confirmed by at least 2 of these 3 things: a liver enzyme called ALP being higher than normal for at least 6 months; a positive blood test for certain antibodies linked to PBC; or a previous liver biopsy showing signs of PBC.
- Your liver enzyme ALP must be at least 1.67 times the upper limit of normal, OR your total bilirubin (a substance measured in blood) must be above normal but less than 1.5 times the upper limit of normal.
- Certain other blood test results must be within acceptable ranges at the time you join: liver enzymes ALT and AST must not be too high, total bilirubin must be below a certain level, and a blood clotting measure called INR must be within normal range (confirm with trial site).
- You must have been taking a medication called UDCA (ursodeoxycholic acid) for at least 12 months, or at least 6 months if your response to it has levelled off, with no change in your dose for at least 3 months before the trial starts.
- You must weigh at least 40 kg (about 88 lbs) and have a body mass index (BMI) between 18 and 40.
Who may not be able to join:
- Women who are physically able to become pregnant, unless they are using a highly effective form of contraception starting 30 days before the trial, throughout the trial, and for 30 days after treatment ends.
- People who have another liver disease in addition to PBC.
- People who have advanced liver scarring (cirrhosis) with serious complications, such as bleeding from swollen veins in the digestive tract, uncontrolled fluid build-up in the abdomen, confusion caused by liver failure, or a serious abdominal infection.
- People with significant liver failure (as measured by specific medical scoring systems), a history of liver transplant, currently waiting for a liver transplant, or a liver disease severity score of 15 or higher (confirm with trial site).
- People who have a medical condition that can cause ALP levels to rise for reasons unrelated to PBC, such as Paget's disease (a bone condition).
- People who are currently taking, or have recently taken, experimental drugs or immune-suppressing medications (with some exceptions for certain steroid medications used for other conditions — confirm with trial site).
- People who are currently taking, or have taken within the last 30 days, a medication called obeticholic acid.
- People who previously took part in a specific related study (CLJN452X2201) and received study medication within 3 months of joining this trial.
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
Fold Change in Serum Gamma-glutamyl Transferase (GGT); Blood Pressure; Pulse Rate; Body Temperature; ECG - Heart Rate; ECG Intervals - PR Interval; Haemoglobin
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.