Trials / Recruiting
RecruitingNCT06948214
Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
A Multicenter, 12-Month, Randomized, Double Blind, Placebo-Controlled Phase 3 Efficacy and Safety Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children With Growth Hormone Deficiency (GHD)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Lumos Pharma · Industry
- Sex
- All
- Age
- 3 Years – 11 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LUM-201 | 1.6 mg/kg/day, administered orally once daily |
| OTHER | Matched Placebo (Capsules) | Administered orally once daily |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2027-12-01
- Completion
- 2028-01-01
- First posted
- 2025-04-29
- Last updated
- 2026-04-06
Locations
23 sites across 3 countries: United States, New Zealand, United Kingdom
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06948214. Inclusion in this directory is not an endorsement.