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ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

NCT03602560Phase 3Completed

Lead sponsor
Gilead Sciences (Industry)
Enrollment
265 (actual)
Start date
1 Oct 2018
Primary completion
16 Feb 2020 (actual)
Study completion
16 Feb 2020
Last update posted
2 Aug 2022

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Double
Arms
3

Interventions

  • seladelpar 5-10 mg Drug
  • seladelpar 10 mg Drug
  • Placebo Drug

Conditions and primary outcome

  • Primary Biliary Cholangitis

Primary outcome

Percentage of Participants With Response to Composite Endpoint of ALP <1.67 × Upper Limit of Normal [ULN], ≥15% Reduction in ALP, and Total Bilirubin ≤ ULN) at Month 3 (Month 3)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT03602560 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Percentage of Participants With Response to Composite Endpoint of ALP <1.67 × Upper Limit of Normal [ULN], ≥15% Reduction in ALP, and Total Bilirubin ≤ ULN) at Month 3

    Time frame
    Month 3
    Measure
    Count of participants
    Unit
    Participants

    • Seladelpar 10 mg vs PlaceboOther

      Estimate
      Not given
      CI
      Not given
      p-value
      <0.0001
      Method
      Cochran-Mantel-Haenszel

    • Seladelpar 5-10 mg vs PlaceboOther

      Estimate
      Not given
      CI
      Not given
      p-value
      <0.0001
      Method
      Cochran-Mantel-Haenszel

Serious adverse events

Time frame: An AE will be recorded any time after the time of signed ICF and captured until this double-blinded study's last study visit, up to 1 year.

Participants with serious adverse events per group for NCT03602560, as posted
GroupAffectedAt risk
Seladelpar 5/10 mg389
Seladelpar 10 mg189
Placebo387

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

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

Results from company and journal sources

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

Publications

1 on PubMed

  1. Serum Metabolomic Profiling Reveals Potential Mechanisms and Biomarkers of Seladelpar Treatment in Patients With Primary Biliary Cholangitis.

    PPAR research · 2026

    PubMed 42798953 (opens in a new tab)DOI 10.1155/ppar/2362528 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

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

Nothing on this page is medical or investment advice.