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

NCT06060665 · IDEAL Phase 3Completed

Lead sponsor
Gilead Sciences (Industry)
Enrollment
96 (actual)
Start date
5 Sep 2023
Primary completion
6 May 2026 (actual)
Study completion
6 May 2026
Last update posted
4 Jun 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Double
Arms
2

Interventions

  • Seladelpar 10 mg Drug
  • Placebo Drug

Conditions and primary outcome

  • Primary Biliary Cholangitis

Primary outcome

Percentage of Participants Response defined as Alkaline phosphatase (ALP) ≤ 1.0× Upper Limit of Normal (ULN) AND ≥ 15% Decrease in ALP at Week 52. (52 weeks); Type, Frequency, and Severity of Treatment-emergent Adverse Events. (52 weeks)

Posted results on ClinicalTrials.gov

Results posted on ClinicalTrials.gov: No

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

No PubMed citation lists NCT06060665.

CT-VCA trial quality

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Data integrity

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Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

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