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Clinical Trials in the EU / 2025-523820-26-00
Authorised 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)

2025-523820-26-00 · tracked via the Priya Life Science EU tracker
Sponsor
Lumos Pharma LLC
Sponsor type
Pharmaceutical company
Therapeutic area
Hormonal diseases
Decision date
18/02/2026
Enrollment target
57
Sites
Romania, France, Italy, Poland, Spain

Condition studied

Growth Hormone Deficiency (GHD)

Investigational medicinal product(s)

Ibutamoren MesylateIbutamoren MesylateMatched placebo capsules administered orally once per dayIbutamoren Mesylate

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 2025-523820-26-00 on CTIS ↗ ← All trials in the EU