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

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523820-26-00

Enrollment

Registered

2026-02-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Deficiency (GHD)

Brief summary

AHV from Day 1 to Month 12 in the LUM-201 and placebo arms

Detailed description

• Change from baseline in IGF-1 SDS, • Change from baseline in HT-SDS, • Change from baseline in IGFBP-3 SDS, • IGF-1 SDS, • HT SDS, • IGFBP-3 SDS

Interventions

DRUGMatched placebo capsules administered orally once per day

DRUGIbutamoren Mesylate

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
AHV from Day 1 to Month 12 in the LUM-201 and placebo arms	—

Secondary

Measure	Time frame
• Change from baseline in IGF-1 SDS, • Change from baseline in HT-SDS, • Change from baseline in IGFBP-3 SDS, • IGF-1 SDS, • HT SDS, • IGFBP-3 SDS	—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 20, 2026