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 tested two doses of an investigational drug called EDP-305 (1 mg and 2.5 mg) against a placebo (an inactive treatment) in 68 people in total — 31 in the 1 mg group, 28 in the 2.5 mg group, and 9 in the placebo group. The trial ran for 12 weeks and was primarily measuring whether participants' blood levels of a liver enzyme called alkaline phosphatase (ALP) — a marker sometimes monitored in liver conditions — dropped by at least 20%, or returned to a normal range, by the end of the study. The reported data shows that 45.2% of participants in the 1 mg group and 46.4% in the 2.5 mg group met that ALP target, compared with 11.1% in the placebo group. For the secondary outcomes, the trial also tracked unwanted medical events (called adverse events) that occurred during treatment. According to the results reported on ClinicalTrials.gov, 71.0% of the 1 mg group, 89.3% of the 2.5 mg group, and 88.9% of the placebo group experienced at least one such event during the study period. Serious adverse events (those considered medically significant, such as requiring hospitalisation) were reported in 3.2% of the 1 mg group, 7.1% of the 2.5 mg group, and 0% of the placebo group. The reported data also shows that 3.2% of the 1 mg group and 17.9% of the 2.5 mg group stopped taking the study treatment because of an adverse event, compared with 0% in the placebo group. The trial also measured changes in several other liver-related blood markers (including ALT, AST, GGT, and bilirubin) from the start to the end of the 12 weeks. The reported data shows varying degrees of change across the groups for each of these markers, though a full breakdown of what each individual number means in a clinical context was not provided in the submitted results. 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 are between 18 and 75 years old (any gender or ethnic background)
- You have been diagnosed with a liver condition called Primary Biliary Cholangitis (PBC), confirmed by at least two specific medical tests or results
- If you have not had a liver biopsy in the last 2 years, you must have had a special liver stiffness scan (FibroScan) showing your liver stiffness is below a certain level
- You have been taking a stable dose of a medication called UDCA for at least 6 months before the study starts, or your doctor has decided you cannot tolerate UDCA and you have not taken it for at least 12 weeks before the study starts
- Your liver-related blood test results (specifically ALP and/or bilirubin) are above certain levels, as confirmed by your doctor
- Your blood tests show no current infection with Hepatitis B, Hepatitis C, or HIV (note: people previously cured of Hepatitis C for at least 3 years may still be eligible)
- If you are a woman who could become pregnant, you must agree to use two reliable forms of contraception from the start of the study until 90 days after your last dose of the study drug
- If you are a man who has not had a vasectomy, you must use effective contraception from the day before your first dose until 90 days after your last dose
- If you are a man, you must agree not to donate sperm from the start of the study until 90 days after your last dose
- Your body mass index (BMI) is 18 or above
- You are willing and able to follow all the visit schedules, rules, and requirements of the study
Who may not be able to join:
- Your liver enzyme blood test results (AST or ALT) are more than 5 times the normal upper limit
- You have a condition called Gilbert's syndrome, which affects how the body processes bilirubin
- Your white blood cell count, neutrophil count, or platelet count is below certain levels in your blood tests
- Your blood clotting test result (INR) is above 1.2
- Your kidney function test results are outside acceptable levels
- Your doctor suspects you have significant fat build-up in the liver unrelated to PBC (a condition called NAFLD)
- You have taken certain immune-suppressing medications known to affect the liver (such as methotrexate or steroids) in the 3 months before the study
- You are currently taking a type of medication called fibrates (including fenofibrate), unless you stopped taking them at least 3 months before the study
- You have taken an experimental treatment for PBC in the last 6 months
- You have another liver or bile duct condition, such as hepatitis, liver cirrhosis, liver cancer, alcoholic liver disease, or a history of serious bleeding related to liver problems
- You have had serious complications of cirrhosis, such as a specific type of kidney failure, prior bleeding from enlarged veins in the food pipe, uncontrolled confusion related to liver disease, or fluid build-up in the abdomen (within the past 6 months)
- You have a non-liver condition that can raise certain liver-related test results (such as Paget's disease of the bone)
- You have recently started a new statin (cholesterol) medication, or plan to change your statin dose during the study (a stable statin dose for at least 3 months before the study is acceptable)
- You have taken immune-suppressing medications (such as steroid tablets) for more than 2 weeks in a row at any point in the year before the study
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
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
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants With At Least a 20% Reduction in Alkaline Phosphatase (ALP) or Normalization of ALP at Week 12 Compared to Baseline
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.