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NCT02609048 · ClinicalTrials.gov registry record · Phase 2

Study to Evaluate the Effects of Two Doses of Seladelpar (MBX-8025) in Subjects With Primary Biliary Cirrhosis (PBC)

A Phase 2 study, sponsored by Gilead Sciences.

Terminated
Registry status
Phase 2
Development phase
41
Enrollment target

NCT02609048: Clinical Trial Phase 2 study, sponsored by Gilead Sciences.

NCT02609048 is a Phase 2 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02609048, a Phase 2 study, was terminated before completion, sponsored by Gilead Sciences.

TERMINATED
Registry status
Phase 2
Development phase
41 participants
Enrollment target

Study Summary

The primary objective of this study is to evaluate the effect of seladelpar (MBX-8025) on alkaline phosphatase (AP) levels in participants with primary biliary cirrhosis (PBC).

Primary Outcome

Baseline for AP level was defined as the mean between assessments at Visit 1 (Week -4 to Week 0) and Visit 2 (Week 0).

Interventions

  • DRUG Placebo Comparator
  • DRUG Experimental: Seladelpar 50 mg
  • DRUG Experimental: Seladelpar / MBX-8025 200 mg

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2015-11-04
Est. Completion 2016-07-01
Phase Phase 2
Gilead Sciences

504 total trials

Why NCT02609048 stopped before completion

NCT02609048 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo Comparator is the first listed.

NCT02609048 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02609048 about?

NCT02609048 is a clinical study titled "Study to Evaluate the Effects of Two Doses of Seladelpar (MBX-8025) in Subjects With Primary Biliary Cirrhosis (PBC)". The primary objective of this study is to evaluate the effect of seladelpar (MBX-8025) on alkaline phosphatase (AP) levels in participants with primary biliary cirrhosis (PBC).

What is the current status of trial NCT02609048?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2015-11-04. Estimated completion is 2016-07-01.

What interventions are being tested in trial NCT02609048?

The interventions under investigation include: Placebo Comparator (DRUG), Experimental: Seladelpar 50 mg (DRUG), Experimental: Seladelpar / MBX-8025 200 mg (DRUG).

Who is sponsoring clinical trial NCT02609048?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02609048's enrollment target sits among peer trials

41 1352nd of 2000 higher than 639 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02609048, the US trial registry maintained by the National Library of Medicine. NCT02609048 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.