drugset / Trial / NCT06948214

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

NCT06948214

Phase 3 Recruiting 150 enrolled Lumos Pharma
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

EvaluationDrugModalityDoseRoute
Subject LUM-201 Unknown 1.6 mg/kg Oral

Indications