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NCT03400163 · ClinicalTrials.gov registry record · Phase 2

A Sub-study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)

A Phase 2 study, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 2
Development phase
3
Enrollment target

NCT03400163: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.

NCT03400163 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03400163, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 2
Development phase
3 participants
Enrollment target

Study Summary

The purpose of this sub-study of MB130-045 is to determine the pharmacokinetic effects, pharmacodynamic effects, efficacy and safety of BMS-986036 20 mg QD in subjects with Non-alcoholic Steatohepatitis (NASH)

Primary Outcome

The mean change in percent hepatic fat fraction (%) by MRI from baseline to Week 16 was assessed for each arm. A longitudinal repeated measures analysis was used to analyze the change in hepatic fat fraction (%) at Week 16 from baseline in the treated population who have both a baseline and at least one post-baseline measurement.

Interventions

  • DRUG Placebo
  • DRUG BMS-986036

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2015-05-08
Est. Completion 2017-06-19
Phase Phase 2
Bristol-Myers Squibb

1,025 total trials

What the finished NCT03400163 record still lists

NCT03400163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03400163 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03400163 about?

NCT03400163 is a clinical study titled "A Sub-study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)". The purpose of this sub-study of MB130-045 is to determine the pharmacokinetic effects, pharmacodynamic effects, efficacy and safety of BMS-986036 20 mg QD in subjects with Non-alcoholic Steatohepatitis (NASH)

What is the current status of trial NCT03400163?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2015-05-08. Estimated completion is 2017-06-19.

What interventions are being tested in trial NCT03400163?

The interventions under investigation include: Placebo (DRUG), BMS-986036 (DRUG).

Who is sponsoring clinical trial NCT03400163?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03400163's enrollment target sits among peer trials

3 2001st of 2000 the lowest 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 NCT03400163, the US trial registry maintained by the National Library of Medicine. NCT03400163 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.