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

NCT07305363 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: Clinical Protocol#SELIC-2025-1
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Ischemic Cholangiopathy; Liver Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• serum alkaline phosphatase (ALP)

  Determine the effect of seladelpar on serum alkaline phosphatase (ALP) from baseline to week 26

  26 weeks

Study Arms (1)

Seladelpar

EXPERIMENTAL

Seladelpar 10 mg orally once daily for 52 weeks

Drug: Seladelpar

Interventions

Seladelpar DRUG

Seladelpar is a selective peroxisome proliferator-activated receptor delta (PPAR-δ) agonist

Seladelpar

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Diego: lead

MeSH Terms

Interventions

seladelpar

Central Study Contacts

Medical Director of Liver Transplantation, MD

CONTACT

858-246-2181; v1ajmera@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Of Clinical, Medicine

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 26, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2025-12