Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC)

Key Inclusion Criteria:

Individuals must meet the following criteria to be eligible for study participation:

1. Male or female with a diagnosis of primary biliary cholangitis (PBC) based onhistory.

2. Ursodeoxycholic acid (UDCA) for the 12 months prior to screening (with stable dosefor > 3 months prior to screening) OR intolerant to UDCA (last dose of UDCA > 3months prior to screening).

3. ALP > 1× ULN and < 1.67× ULN.

4. Females of reproductive potential must use at least 1 barrier contraceptive and asecond effective birth control method during the study and for at least 90 daysafter the last dose. Male participants who are sexually active with female partnersof reproductive potential must use barrier contraception, and their female partnersmust use a second effective birth control method during the study and for at least 90 days after the last dose.

Key Exclusion Criteria:

1. Previous exposure to seladelpar (MBX-8025).

2. A medical condition other than PBC that, in the Investigator's opinion, wouldpreclude full participation in the study (eg, cancer) or confound its results.

3. Advanced PBC as defined by the Rotterdam criteria.

4. Laboratory parameters measured by the Central Laboratory at screening.

5. Clinically important hepatic decompensation.

6. Other chronic liver diseases.

7. Known history of human immunodeficiency virus (HIV) or positive antibody test atscreening.

8. Clinically important alcohol consumption, defined as more than 2 drink units per dayin women and 3 drink units per day in men, or inability to quantify alcohol intakereliably.

9. History of malignancy diagnosed or treated, active or within 2 years, or ongoingevaluation for malignancy; localized treatment of squamous or noninvasive basal cellskin cancers and cervical carcinoma in situ is allowed if appropriately treatedprior to screening.

10. History of drug abuse that would compromise the quality of the clinical study.

11. Treatment with obeticholic acid or fibrates 6 weeks prior to screening.

12. Treatment with colchicine, methotrexate, azathioprine, or long-term systemiccorticosteroids within 2 months prior to screening.

13. Initiation or dose adjustment of anti-pruritic drugs indicated for the treatment ofpruritus within 1 month prior to screening.

14. Immunosuppressant therapies within 6 months prior to screening.

15. Other medications that affect liver or gastrointestinal functions, as well as theroux-en-y gastric bypass procedure, may be prohibited and should be discussed withthe medical monitor on a case by-case basis.

16. Treatment with any other investigational therapy or device within 30 days or withinhalflives, whichever is longer, prior to screening.

17. Pregnancy or plans to become pregnant, or breastfeeding.

18. Any other condition(s) that would compromise the safety of the individual orcompromise the quality of the clinical study, as judged by the investigator.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.