Recruiting
Phase 2

Seladelpar & Cilofexor

Sponsor:

Gilead Sciences

Code:

NCT07841977

Conditions

Primary Biliary Cholangitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Seladelpar

PTM Seladelpar

Cilofexor Dose B

PTM Cilofexor Dose A

PTM Cilofexor Dose B

Study Details

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

Study ID

NCT07841977

Start date

Oct 1, 2026

Status verified date

Oct, 2026

Completion date

Jun, 2034

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Have a diagnosis of primary biliary cholangitis (PBC) as defined by a history of any 2 of the following criteria:

1. ALP above 1.0 × the ULN for at least 6 months
2. Positive antimitochondrial antibody titer (> 1:40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay) or positive PBC-specific antinuclear antibodies
3. 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

Key Exclusion Criteria:

  • 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 study
  • 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

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

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

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

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.

active comparator: SEL 10 mg + PTM CILO Dose A + PTM CILO Dose B

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.

placebo comparator: PTM SEL 10 mg + PTM CILO Dose A + PTM CILO Dose B

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.

Interventions

Seladelpar

Capsule administered orally

PTM Seladelpar

Capsule administered orally

Cilofexor Dose B

Tablet administered orally

PTM Cilofexor Dose A

Tablet administered orally

PTM Cilofexor Dose B

Tablet administered orally

Cilofexor Dose A

Tablet administered orally

Primary outcome measure

  • Change From Baseline in Serum Concentration of Alkaline Phosphate (ALP) at Week 24 [ Time Frame: Baseline, Week 24 ]
  • Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: First dose up to 30 days post last dose (up to 318 weeks) ]
  • Percentage of Participants Experiencing Serious Adverse Events (SAEs) [ Time Frame: First dose up to 30 days post last dose (up to 318 weeks) ]

Central Contacts and Locations

Central contacts

Gilead Clinical Study Information Center

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

Locations

Peak Gastroenterology Associates

Recruiting

Colorado Springs, Colorado, United States, 80907

Florida Research Institute

Recruiting

Lakewood Rch, Florida, United States, 34211

Digestive Healthcare of Georgia

Recruiting

Atlanta, Georgia, United States, 30327

GI Associates of Northeast Tennessee

Recruiting

Johnson City, Tennessee, United States, 37604

More Information

Sponsor

Gilead Sciences

Last update posted

Oct 27, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-28. This information was provided to ClinicalTrials.gov by Gilead Sciences on 2026-10-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.