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Clinical Trials in the EU / 2025-523820-26-01
Authorised, not yet recruiting Phase III

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)

2025-523820-26-01 · tracked via the Priya Life Science EU tracker
Sponsor
Lumos Pharma LLC
Sponsor type
Pharmaceutical company
Therapeutic area
Hormonal diseases
Decision date
30/10/2026
Enrollment target
36
Sites
Italy, France, Spain

Condition studied

Growth Hormone Deficiency (GHD)

Investigational medicinal product(s)

Ibutamoren MesylateMatched placebo capsules administered orally once per day

Eligibility

Age group
0-17 years
Sex
Female, Male

Primary endpoint

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

Endpoint detail

• 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

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-523820-26-01 on CTIS ↗ ← All trials in the EU