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NCT04786873 · ClinicalTrials.gov registry record · Phase 3

A Research Study of How Well Macimorelin Works to Find Out if Children Have a Lack of Growth Hormone and How Safe it is

A Phase 3 study, sponsored by AEterna Zentaris.

Completed
Registry status
Phase 3
Development phase
101
Enrollment target

NCT04786873: Completed Phase 3 study, sponsored by AEterna Zentaris.

NCT04786873 is a Phase 3 study that has completed, run by AEterna Zentaris. The registered enrollment target is 101 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04786873, a Phase 3 study, has completed, sponsored by AEterna Zentaris.

COMPLETED
Registry status
Phase 3
Development phase
101 participants
Enrollment target

Study Summary

This research study will find out if a new growth hormone stimulation test is safe and works as well as other tests to diagnose growth hormone deficiency (GHD) in children. The stimulation test will use a new growth hormone stimulating substance called macimorelin. By now, only adults in the USA can get this new stimulation test. The results of this study are expected to help children and teenagers with suspected GHD to get the macimorelin stimulation test. The macimorelin test will be compared to a clonidine and an arginine test. Both are known standard stimulation tests. Altogether two macimorelin tests are planned to be performed in the study, to show how repeatable macimorelin tests results are (under a set of similar conditions).

Primary Outcome

Assuming the outcome of GHD status adjudication final clinical diagnosis as the "true" GHD status, the diagnostic efficacy (estimated sensitivity, specificity, misclassification) of the macimorelin GHST will be based on the area under the receiver operating characteristic curve (ROC AUC).

Interventions

  • DRUG Macimorelin
  • DIAGNOSTIC_TEST Arginine
  • DIAGNOSTIC_TEST Clonidine

Trial Details

FieldValue
Enrollment Target 101 participants
Start Date 2021-11-16
Est. Completion 2024-06-13
Phase Phase 3
AEterna Zentaris

21 total trials

What the finished NCT04786873 record still lists

NCT04786873 is an interventional study that assigns participants to a tested intervention. The registered 101 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 (87% lower).

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

NCT04786873 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04786873 about?

NCT04786873 is a clinical study titled "A Research Study of How Well Macimorelin Works to Find Out if Children Have a Lack of Growth Hormone and How Safe it is". This research study will find out if a new growth hormone stimulation test is safe and works as well as other tests to diagnose growth hormone deficiency (GHD) in children. The stimulation test will use a new growth hormone stimulating substance called macimorelin. By now, only adults in the USA can...

What is the current status of trial NCT04786873?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 101 participants. The study started on 2021-11-16. Estimated completion is 2024-06-13.

What interventions are being tested in trial NCT04786873?

The interventions under investigation include: Macimorelin (DRUG), Arginine (DIAGNOSTIC_TEST), Clonidine (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT04786873?

This trial is sponsored by AEterna Zentaris, which has 21 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04786873's enrollment target sits among peer trials

101 1680th of 2000 higher than 320 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 NCT04786873, the US trial registry maintained by the National Library of Medicine. NCT04786873 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.