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NCT04614337 · ClinicalTrials.gov registry record · Phase 2

Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial)

A Phase 2 study, sponsored by Lumos Pharma.

Completed
Registry status
Phase 2
Development phase
104
Enrollment target

NCT04614337: Completed Phase 2 study, sponsored by Lumos Pharma.

NCT04614337 is a Phase 2 study that has completed, run by Lumos Pharma. The registered enrollment target is 104 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04614337, a Phase 2 study, has completed, sponsored by Lumos Pharma.

COMPLETED
Registry status
Phase 2
Development phase
104 participants
Enrollment target

Study Summary

This is a multi-national trial. The goals of the trial are to study LUM-201 as a possible treatment for Pediatric Growth Hormone Deficiency (PGHD) and investigate a predictive enrichment marker (PEM) strategy to select subjects likely to respond to therapy with LUM-201.

Primary Outcome

Annualized height velocity (AHV); Height is measured in triplicate, by a calibrated stadiometer and taking the mean value AVH equation is (h2-h1/t2-t1)\*365.25; h1 = height measured at day 1 h2 = height measured at month 6 t1 = day 1 t2 = month 6

Interventions

  • DRUG LUM-201
  • DRUG rhGH Norditropin® pen (34 µg/kg)

Trial Details

FieldValue
Enrollment Target 104 participants
Start Date 2020-12-31
Est. Completion 2024-09-04
Phase Phase 2
Lumos Pharma

3 total trials

What the finished NCT04614337 record still lists

NCT04614337 is an interventional study that assigns participants to a tested intervention. The registered 104 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 (22% lower).

The record links to 0 conditions, and to 2 interventions - of which LUM-201 is the first listed.

NCT04614337 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04614337 about?

NCT04614337 is a clinical study titled "Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial)". This is a multi-national trial. The goals of the trial are to study LUM-201 as a possible treatment for Pediatric Growth Hormone Deficiency (PGHD) and investigate a predictive enrichment marker (PEM) strategy to select subjects likely to respond to therapy with LUM-201.

What is the current status of trial NCT04614337?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2020-12-31. Estimated completion is 2024-09-04.

What interventions are being tested in trial NCT04614337?

The interventions under investigation include: LUM-201 (DRUG), rhGH Norditropin® pen (34 µg/kg) (DRUG).

Who is sponsoring clinical trial NCT04614337?

This trial is sponsored by Lumos Pharma, which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04614337's enrollment target sits among peer trials

104 660th of 2000 higher than 1,337 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 NCT04614337, the US trial registry maintained by the National Library of Medicine. NCT04614337 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.