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NCT02955602 · ClinicalTrials.gov registry record · Phase 2

Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)

A Phase 2 study, sponsored by Gilead Sciences.

Completed
Registry status
Phase 2
Development phase
119
Enrollment target

NCT02955602: Completed Phase 2 study, sponsored by Gilead Sciences.

NCT02955602 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 119 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02955602, a Phase 2 study, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 2
Development phase
119 participants
Enrollment target

Study Summary

An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)

Primary Outcome

Relative change from baseline in serum ALP levels at Week 8 (endpoint). The modified Intent-to-Treat (mITT) analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment. n, denotes number of subjects evaluable for the respective timepoints

Interventions

  • DRUG MBX-8025 2 mg Capsule
  • DRUG MBX-8025 5 mg Capsule
  • DRUG MBX-8025 10 mg Capsule

Trial Details

FieldValue
Enrollment Target 119 participants
Start Date 2016-11-28
Est. Completion 2019-07-08
Phase Phase 2
Gilead Sciences

504 total trials

What the finished NCT02955602 record still lists

NCT02955602 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower).

The record links to 0 conditions, and to 3 interventions - of which MBX-8025 2 mg Capsule is the first listed.

NCT02955602 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02955602 about?

NCT02955602 is a clinical study titled "Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)". An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)

What is the current status of trial NCT02955602?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 119 participants. The study started on 2016-11-28. Estimated completion is 2019-07-08.

What interventions are being tested in trial NCT02955602?

The interventions under investigation include: MBX-8025 2 mg Capsule (DRUG), MBX-8025 5 mg Capsule (DRUG), MBX-8025 10 mg Capsule (DRUG).

Who is sponsoring clinical trial NCT02955602?

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 NCT02955602's enrollment target sits among peer trials

119 618th of 2000 higher than 1,383 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 NCT02955602, the US trial registry maintained by the National Library of Medicine. NCT02955602 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.