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NCT03569007 · ClinicalTrials.gov registry record · Phase 3

Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms

A Phase 3 study, sponsored by 9 Meters Biopharma.

Terminated
Registry status
Phase 3
Development phase
307
Enrollment target

NCT03569007: Clinical Trial Phase 3 study, sponsored by 9 Meters Biopharma.

NCT03569007 is a Phase 3 study that was terminated before completion, run by 9 Meters Biopharma. The registered enrollment target is 307 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03569007, a Phase 3 study, was terminated before completion, sponsored by 9 Meters Biopharma.

TERMINATED
Registry status
Phase 3
Development phase
307 participants
Enrollment target

Study Summary

To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.

Primary Outcome

Reduction in CeD PRO Abdominal Domain scores

Interventions

  • DRUG Matching Placebo
  • DRUG Larazotide

Trial Details

FieldValue
Enrollment Target 307 participants
Start Date 2019-05-29
Est. Completion 2022-07-21
Phase Phase 3
9 Meters Biopharma

9 total trials

Why NCT03569007 stopped before completion

NCT03569007 is an interventional study that assigns participants to a tested intervention. The registered 307 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).

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

NCT03569007 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03569007 about?

NCT03569007 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms". To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.

What is the current status of trial NCT03569007?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 307 participants. The study started on 2019-05-29. Estimated completion is 2022-07-21.

What interventions are being tested in trial NCT03569007?

The interventions under investigation include: Matching Placebo (DRUG), Larazotide (DRUG).

Who is sponsoring clinical trial NCT03569007?

This trial is sponsored by 9 Meters Biopharma, which has 9 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03569007's enrollment target sits among peer trials

307 1115th of 2000 higher than 886 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT03569007, the US trial registry maintained by the National Library of Medicine. NCT03569007 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.