Study of Seladelpar and Cilofexor in Participants With Primary Biliary Cholangitis

NCT07841977 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: GS-US-763-79302026-525722-37
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical study is to learn more about the combination of study drugs seladelpar and cilofexor. The study will assess, the safety, tolerability, and effectiveness of the combination drugs versus both seladelpar alone and placebo, in participants with primary biliary cholangitis (PBC). The primary objective of this study is to determine whether the combination of seladelpar + cilofexor leads to greater alkaline phosphatase (ALP) reduction than seladelpar alone and describe the safety and tolerability of seladelpar + cilofexor.

Conditions

Primary Biliary Cholangitis

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Serum Concentration of Alkaline Phosphate (ALP) at Week 24

  Baseline, Week 24

• Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

  First dose up to 30 days post last dose (up to 318 weeks)

• Percentage of Participants Experiencing Serious Adverse Events (SAEs)

  First dose up to 30 days post last dose (up to 318 weeks)

Secondary Outcomes (3)

• Proportion of Participants Achieving the Biochemistry Composite Endpoint at Week 24

  Week 24

• Proportion of Participants Achieving ALP Normalization at Week 24

  Week 24

• Change From Baseline to Week 24 in Weekly Average Pruritus Numerical Rating Scale (NRS)

  Baseline, Week 24

Study Arms (4)

Seladelpar (SEL) 10 mg + Placebo-to-Match (PTM) Cilofexor (CILO) Dose A + CILO Dose B

EXPERIMENTAL

Participants will receive a dose of SEL 10 mg capsule along with PTM CILO Dose A tablets and CILO Dose B tablets, once daily up to 24 weeks. At completion of Week 24, participants will continue in an Active Treatment Extension (ATE) Period, during which they will receive SEL 10 mg along with either CILO Dose A or Dose B at the original randomized dose in a blinded fashion, up to Week 312.

Drug: Seladelpar; Drug: Cilofexor Dose B; Drug: PTM Cilofexor Dose A

SEL 10 mg + CILO Dose A + PTM CILO Dose B

EXPERIMENTAL

Participants will receive a dose of SEL 10 mg capsule along with CILO Dose A tablets and PTM CILO Dose B tablets, once daily up to 24 weeks. At completion of Week 24, participants will continue in an ATE Period, during which they will receive SEL 10 mg along with either CILO Dose A or Dose B at the original randomized dose in a blinded fashion, up to Week 312.

Drug: Seladelpar; Drug: PTM Cilofexor Dose B; Drug: Cilofexor Dose A

SEL 10 mg + PTM CILO Dose A + PTM CILO Dose B

ACTIVE COMPARATOR

Participants will receive a dose of SEL 10 mg capsule along with PTM CILO Dose A tablets and PTM CILO Dose B tablets, once daily up to 24 weeks. At completion of Week 24, participants will continue in an ATE Period, during which they will initiate open-label SEL 10 mg and be re-randomized in a 1:1 ratio to receive CILO Dose A or Dose B in a blinded fashion, up to Week 312.

Drug: Seladelpar; Drug: PTM Cilofexor Dose A; Drug: PTM Cilofexor Dose B

PTM SEL 10 mg + PTM CILO Dose A + PTM CILO Dose B

PLACEBO COMPARATOR

Participants will receive a dose of PTM SEL 10 mg capsule along with PTM CILO Dose A tablets and PTM CILO Dose B tablets once daily up to 24 weeks. At completion of Week 24, participants will continue in an ATE Period, during which they will initiate open-label SEL 10 mg and be re-randomized in a 1:1 ratio to receive CILO Dose A or Dose B in a blinded fashion, up to Week 312.

Drug: PTM Seladelpar; Drug: PTM Cilofexor Dose A; Drug: PTM Cilofexor Dose B

Interventions

Seladelpar DRUG

Capsule administered orally

SEL 10 mg + CILO Dose A + PTM CILO Dose B; SEL 10 mg + PTM CILO Dose A + PTM CILO Dose B; Seladelpar (SEL) 10 mg + Placebo-to-Match (PTM) Cilofexor (CILO) Dose A + CILO Dose B

PTM Seladelpar DRUG

Capsule administered orally

PTM SEL 10 mg + PTM CILO Dose A + PTM CILO Dose B

Cilofexor Dose B DRUG

Tablet administered orally

Seladelpar (SEL) 10 mg + Placebo-to-Match (PTM) Cilofexor (CILO) Dose A + CILO Dose B

PTM Cilofexor Dose A DRUG

Tablet administered orally

PTM SEL 10 mg + PTM CILO Dose A + PTM CILO Dose B; SEL 10 mg + PTM CILO Dose A + PTM CILO Dose B; Seladelpar (SEL) 10 mg + Placebo-to-Match (PTM) Cilofexor (CILO) Dose A + CILO Dose B

PTM Cilofexor Dose B DRUG

Tablet administered orally

PTM SEL 10 mg + PTM CILO Dose A + PTM CILO Dose B; SEL 10 mg + CILO Dose A + PTM CILO Dose B; SEL 10 mg + PTM CILO Dose A + PTM CILO Dose B

Cilofexor Dose A DRUG

Tablet administered orally

SEL 10 mg + CILO Dose A + PTM CILO Dose B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a diagnosis of PBC as defined by a history of any 2 of the following criteria:
• ALP above 1.0 × the ULN for at least 6 months
• Positive antimitochondrial antibody titer (\> 1:40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay) or positive PBC-specific antinuclear antibodies
• Documented liver biopsy results consistent with PBC
• Used ursodeoxycholic acid (UDCA) for the past 12 months (stable dose for \> 6 months prior to screening), or intolerant to UDCA (last dose of UDCA \> 90 days prior to screening)
• Have an ALP ≥ 1.67 × ULN at screening
• Have a negative serum pregnancy test at screening

You may not qualify if:

• Have other causes of liver disease including viral, alcoholic, autoimmune, and metabolic associated steatohepatitis (MASH).
• Cirrhosis with Child-Pugh Score ≥ 7, corresponding to Class B or C. Individuals with compensated cirrhosis (ie, Child-Pugh Class A) are allowed if they meet all other criteria.
• Have evidence of portal hypertension or clinically important hepatic decompensation (historic or current), including but not limited to: hepatic encephalopathy, known esophageal or gastric varices, history of liver transplantation, current placement on liver transplant list, Model for End Stage Liver Disease score ≥ 12, ascites, spontaneous bacterial peritonitis, hepatorenal syndrome.
• Have previous exposure to seladelpar or cilofexor
• Used obeticholic acid, fenofibrate, bezafibrate, elafibranor, pemafibrate, or saroglitazar within 6 weeks (42 days, inclusive) of screening date
• Require or expect to require treatment with ≥ 5 mg prednisone (or systemic equivalents) for \> 2 weeks during the Blinded Treatment or ATE Periods
• Are on any systemic drug for antipruritic treatment that has required a dose adjustment in the 30 days before screening, or initiated a systemic antipruritic drug in the 30 days before screening

Sponsors & Collaborators

• Gilead Sciences: lead

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

seladelpar

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Central Study Contacts

Gilead Clinical Study Information Center

CONTACT

1-833-445-3230 (GILEAD-0); GileadClinicalTrials@gilead.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 25, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2034
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share