Seladelpar in Adult Liver Transplant Recipients With Ischemic Cholangiopathy (SELIC). (SELIC)

The SELIC Trial Seladelpar for the Treatment of Ischemic Cholangiopathy: An Open-Label, Single-Arm, Investigator-Initiated Study

A prospective, open-label, single-arm, investigator-initiated study (SELIC) to evaluate the efficacy and safety of seladelpar in adult liver transplant recipients with Ischemic cholangiopathy (IC).

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Transplant; Complications; Ischemic Cholangiopathy
• Intervention / Treatment: Drug: Seladelpar

Detailed Description

Ischemic cholangiopathy (IC) is a serious complication after liver transplantation, particularly in recipients of donation after circulatory death grafts, and is associated with cholestasis, biliary strictures, and graft dysfunction. No approved pharmacologic therapies currently exist. Seladelpar, a selective peroxisome proliferator-activated receptor delta (PPAR-δ) agonist recently approved for primary biliary cholangitis, reduces bile acid synthesis and inflammation and has demonstrated antifibrotic activity, making it a promising candidate for IC. We designed a prospective, open-label, single-arm, investigator-initiated study (SELIC) to evaluate the efficacy and safety of seladelpar in adult liver transplant recipients with IC. Ten patients will receive seladelpar 10 mg orally once daily for 52 weeks. Outcomes will be compared to historical controls identified from the same institution. The primary endpoint is percent change in serum alkaline phosphatase (ALP) from baseline to Week 26. Additional outcomes include ERCP utilization, liver allograft loss, and safety assessed by adverse event and laboratory monitoring and drug discontinuation rates. This pilot study will provide the first prospective data on seladelpar in IC and may establish preliminary evidence for a novel therapeutic approach to reduce cholestasis, improve symptoms, and preserve graft function in this high-risk population.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Medical Director of Liver Transplantation, MD; Phone Number: 858-246-2181; Email: v1ajmera@health.ucsd.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

Patients who meet study eligibility criteria will be recruited from UCSD's liver transplant clinic

Description

Inclusion Criteria:

1. Adult, age ≥ 18 and < 80 years
2. Diagnosis of ischemic cholangiopathy defined as non-anastomotic biliary strictures confirmed by imaging (ERCP, MRI, percutaneous cholangiogram)
3. Cholestasis noted by elevated alkaline phosphatase (ALP) and gamma glutamyl transferase (GGT)
4. Imaging and clinical findings present at least 4 weeks after but within 12 months of liver transplantation
5. No recent hospitalization within 2 weeks before enrollment to ensure clinical stability

Exclusion Criteria:

1. Decompensated liver disease, including but not limited to ascites requiring paracentesis, hepatic encephalopathy, or variceal bleeding.
2. Pregnancy or breastfeeding.
3. Current or recent (within 30 days) use of other investigational agents or fenofibrate.
4. Current or recent (within 30 days) use of cyclosporine
5. Known hypersensitivity or contraindication to seladelpar or its excipients.
6. Severe concomitant illness (renal, cardiac, or other systemic condition) that, in the investigator's judgment, would interfere with study participation or interpretation of results.
7. ALT > 150 IU/L.
8. AST > 150 IU/L.
9. Total bilirubin > 5 mg/dL at screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Seladelpar; Seladelpar 10 mg orally once daily for 52 weeks	Drug: Seladelpar; Seladelpar is a selective peroxisome proliferator-activated receptor delta (PPAR-δ) agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum alkaline phosphatase (ALP)	Determine the effect of seladelpar on serum alkaline phosphatase (ALP) from baseline to week 26	26 weeks

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 12, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: seladelpar
• Other Study ID Numbers: Clinical Protocol#SELIC-2025-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No