drugset / Trial / NCT06948214
Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2026-05-20
- Primary completion
- 2027-12
- Completion
- 2028-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LUM-201 | Unknown | 1.6 mg/kg | Oral |