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Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency

NCT06948214 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-05-12

No results posted yet for this study

Summary

The OraGrowtH Phase 3 Trial is a multi-national trial. The goals of the trial are to study LUM-201 as a treatment for Pediatric Growth Hormone Deficiency (PGHD) in naive to treatment children and validate the LUM-201 predictive enrichment marker (LUM-201 PEM) strategy to select subjects likely to respond to therapy with daily oral LUM-201.

Conditions

  • Growth Hormone Deficiency (GHD)

Interventions

DRUG

LUM-201

1.6 mg/kg/day, administered orally once daily

OTHER

Matched Placebo (Capsules)

Administered orally once daily

Sponsors & Collaborators

  • Lumos Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-12-31
Completion
2028-01-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Australia
  • New Zealand
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06948214 on ClinicalTrials.gov