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 (NCT03602560) looked at a medicine called seladelpar in people with a liver condition. A total of 265 people took part — 89 in a group that started on a lower dose of seladelpar (5 mg) and could move up to a higher dose (10 mg), 89 in a fixed higher-dose group (10 mg), and 87 in a placebo group (a dummy treatment with no active medicine). The trial was measuring whether seladelpar could hit a combination target related to a liver enzyme called alkaline phosphatase (ALP) and another liver marker called total bilirubin, checked at three months. The reported data shows that for the main combined target at three months, 32 out of 89 participants in the 5–10 mg group, 43 out of 89 in the 10 mg group, and 7 out of 87 in the placebo group met the criteria. For one of the secondary measures — whether ALP levels returned to within the normal range — the reported numbers were 3 out of 89 in the 5–10 mg group, 15 out of 89 in the 10 mg group, and 0 out of 87 in the placebo group. The trial also measured itching (rated on a 0–10 scale, where 0 means no itch and 10 means the worst imaginable) among participants who reported moderate-to-severe itching at the start. The reported average change in itch score from the start of the trial to three months was −1.95 points in the 5–10 mg group, −3.01 points in the 10 mg group, and −1.44 points in the placebo group (negative numbers indicate a reduction in reported itching). It is worth noting that the reported data shows only 1 participant in each group was recorded as having completed the study, with the large majority listed as "not completed" — the reasons for this were not detailed in the data provided on 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 ↗
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 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 willing and able to sign a consent form agreeing to take part in the study
- You are between 18 and 75 years old
- You have been diagnosed with Primary Biliary Cholangitis (PBC), confirmed by at least two of the following: abnormal liver enzyme levels for at least 6 months, a positive blood test for specific antibodies linked to PBC, or a liver biopsy showing signs of PBC
- You have been taking UDCA (a common medication for PBC) at a stable, recommended dose for the past 12 months, OR you cannot tolerate UDCA and stopped taking it more than 3 months before the screening visit
- Your alkaline phosphatase (a liver enzyme measured in a blood test) is at a certain elevated level above the normal range (confirm with trial site)
- If you are a woman who could become pregnant, or a man whose partner could become pregnant, you must be willing to use two forms of birth control during the study and for at least 90 days after the last dose
Who may not be able to join:
- You have previously taken the study drug, seladelpar (also known as MBX-8025)
- You have another serious medical condition (such as cancer) that the doctor feels would interfere with the study
- Your liver enzyme levels (AST or ALT) are more than 3 times the upper limit of normal on a blood test
- Your total bilirubin (a measure of liver function in your blood) is more than twice the upper limit of normal
- You have advanced PBC, defined by having both low albumin and elevated bilirubin levels in your blood
- Your creatine kinase (a muscle-related enzyme in your blood) is above the normal range
- Your kidneys are not functioning well enough, based on a specific calculation from your blood test (confirm with trial site)
- Your blood clotting levels (INR) are above the normal range
- Your platelet count (cells that help your blood clot) is below a certain level
- You have signs of serious liver failure, such as being on a liver transplant list, having a MELD score of 15 or higher, having complications such as swollen veins in the food pipe, fluid build-up in the abdomen, or episodes of confusion caused by liver disease
- You have another chronic liver condition, such as autoimmune hepatitis, a bile duct disease called primary sclerosing cholangitis, liver disease caused by alcohol, alpha-1-antitrypsin deficiency, a type of fatty liver disease (NASH confirmed by biopsy), Gilbert's syndrome with high bilirubin, hemochromatosis (iron overload), active Hepatitis B or Hepatitis C
- You have a known history of HIV
- You drink significant amounts of alcohol
- You use recreational drugs
- You previously tried a medication called obeticholic acid (OCA) and either it didn't work well enough or you couldn't tolerate it — and you have not stopped taking it at least 30 days before the screening visit
- You have taken certain medications (colchicine, methotrexate, azathioprine, or long-term steroid tablets for more than 2 weeks) within the past two months
- You have taken fibrate medications (a type of cholesterol or fat-lowering drug) within the past 30 days
- You have taken simvastatin (a cholesterol-lowering drug) within the past 7 days
- You have taken any other experimental or unapproved treatment for PBC or an unapproved immune-suppressing drug within the past 30 days
- You have taken part in any other clinical trial or used another experimental treatment within the past 30 days (or longer, depending on the drug)
- You are currently pregnant or breastfeeding
- The study doctor feels that any other condition you have could put you at risk or affect the results of 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
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants With Response to Composite Endpoint of ALP <1.67 × Upper Limit of Normal [ULN], ≥15% Reduction in ALP, and Total Bilirubin ≤ ULN) at Month 3
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.