Phase 2
Completed N=15
Phase 2 Study of LUM-201 in Children Who Have Previously Completed the LUM-201-01 Trial (OraGrowtH213)
Source: ClinicalTrials.gov NCT05250063 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcomePrimary: Annualized Height Velocity (AHV) Measured as Standing Height With Stadiometer — 0.098 cm/year
Summary
This is a multi-national trial. The goals of the trial are to study the growth response to LUM-201 administration in children with idiopathic growth hormone deficiency (GHD) previously treated with daily rhGH for 12 months in the LUM-201-01 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Height Velocity (AHV) Measured as Standing Height With Stadiometer |
0.098 | — |
| SECONDARY Occurrence of Adverse Events in Children With Growth Hormone Deficiency (GHD) |
42 | — |
| SECONDARY Growth Hormone (GH) Values |
-0.05; 1.17 | — |
| SECONDARY Insulin-Like Growth Factor 1 (IGF-1) Values |
-8.75 | — |
| SECONDARY Insulin-Like Growth Factor Binding Protein 3 (IGFBP-3) Values |
-58.033 | — |
| SECONDARY Height (HT) Standard Deviation Score (SDS) |
0.08229 | — |
| SECONDARY Change in Weight |
4.19 | — |
| SECONDARY Change in Weight - Standard Deviation Score (SDS) |
0.62279 | — |
| SECONDARY Change in Body Mass Index (BMI) |
0.969 | — |
| SECONDARY Change in Body Mass Index (BMI) - Standard Deviation Score (SDS) |
0.32057 | — |
| SECONDARY Change in Bone Age |
2.01 | — |
| SECONDARY Insulin-Like Growth Factor 1 (IGF-1) - Standard Deviation Score (SDS) |
-1.1083 | — |
Eligibility Criteria
Inclusion Criteria
- Parent/caregiver must sign the informed consent, and the subject must sign the assent, as applicable.
- Must have previously completed 12 months of daily rhGH treatment as part of the LUM-201-01 PGHD trial.
- Is eligible for study participation as confirmed by the principal investigator (PI)
Exclusion Criteria
- Has a medical condition that, in the opinion of the PI and/or MM, adds unwarranted risk to use of LUM-201.
- Uses any medication that, in the opinion of the PI and/or MM, can independently cause short stature or limit the response to exogenous growth factors.
- Has planned or is receiving current long-term treatment with medications known to act as substrates, inducers, or inhibitors of the cytochrome system CYP3A4 that metabolizes LUM-201
Data sourced from ClinicalTrials.gov (NCT05250063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.