Phase 3 Primary Biliary Cholangitis Trial, Completed

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have given written consent to participate, as required by local laws.
• People who have received a confirmed diagnosis of primary biliary cholangitis (PBC), a liver condition.
• People who have been taking a medication called ursodeoxycholic acid (UDCA) for at least 12 months at a stable dose, or people who stopped taking UDCA more than 3 months before the screening visit due to not tolerating it.
• People whose blood test results at screening fall within the specific ranges required by the trial, including certain liver enzyme levels, kidney function, blood clotting, and platelet counts (confirm specific values with the trial site).
• People who are able to use at least two forms of birth control during the study and for at least 90 days after the last dose, as applicable to their situation.

Who may not be able to join:

• People who have previously taken the study drug, seladelpar (also called MBX-8025).
• People who have another significant medical condition — such as cancer or an active infection — that the study doctor believes would interfere with participation or affect the results.
• People whose PBC is considered advanced, based on specific blood test results for albumin and bilirubin levels (confirm with trial site).
• People who have experienced serious liver complications, such as liver failure, are on a liver transplant waiting list, have a certain liver disease severity score, or have had complications such as internal bleeding from swollen veins, fluid build-up in the abdomen, or confusion caused by liver problems.
• People who have other chronic liver conditions, including autoimmune hepatitis, a bile duct condition called primary sclerosing cholangitis (PSC), alcoholic liver disease, alpha-1-antitrypsin deficiency, a confirmed diagnosis of non-alcoholic steatohepatitis (NASH), Gilbert's syndrome with elevated bilirubin, hemochromatosis, active hepatitis B or C, or any suspected or confirmed liver or bile duct cancer.
• People who have a known or newly detected HIV infection.
• People who regularly drink more alcohol than the trial's defined limit — more than 2 standard drinks per day for women or 3 per day for men — or who cannot reliably estimate how much they drink.
• People who have been diagnosed with or treated for cancer within the past 2 years, or who are currently being investigated for cancer (certain minor treated skin cancers and cervical carcinoma in situ may be exceptions — confirm with the trial site).
• People who have taken certain medications, including obeticholic acid or fibrates, within 6 weeks before screening.
• People who have taken certain other medications — including colchicine, methotrexate, azathioprine, or long-term steroid tablets — within 2 months before screening.
• People who are taking anti-itch medications and whose dose has not been stable for at least 1 month before screening.
• People who have taken part in another clinical trial or used an experimental treatment within 30 days before screening, or within 5 times the elimination period of that treatment, whichever is longer.
• People who are pregnant or breastfeeding.
• People taking immunosuppressant medications.
• People taking other medications or who have had procedures that affect how the liver or digestive system absorbs medicines — these cases would be reviewed individually by the study's medical team.
• People who have an active COVID-19 infection at the time of screening.
• People whose overall health or circumstances, in the study doctor's judgement, could make participation unsafe or affect the quality of the study.

Important: Always verify eligibility with the trial site directly before applying.