A phase 2 trial
for children with Pediatric Growth Hormone Deficiency
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OraGrowtHTrials is a clinical trial program involving an oral investigational drug, called LUM-201, for Pediatric Growth Hormone Deficiency (PGHD).
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This investigational drug for PGHD is an oral tablet.
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It is different from the currently approved injections of recombinant human growth hormone (rhGH) for children with Growth Hormone Deficiency.
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The trial is for participants aged 3-12.
What is the OraGrowtH210 Trial?
OraGrowtH210 Trial is a research trial studying LUM-201(ibutamoren) as a potential oral treatment for Pediatric Growth Hormone Deficiency (PGHD) in pre-pubertal children.
OraGrowtH210 Trial is a Phase 2 randomized trial.
https://www.fda.gov/patients/drug-development-process/step-3-clinical-research#phases
The sponsor of this research study is Lumos Pharma.
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What is the Purpose of the Trial?
The purpose of the OraGrowtH210 Trial is to study the investigational drug in PGHD by:
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Assessing different daily oral dosages to find an optimal dose of LUM-201. Some children will be randomly assigned to the current standard of care (rhGH injections)
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Observing safety and tolerability
Participants in this Trial
Pre-pubertal children, ages 3-12, diagnosed with PGHD, but have not started any Growth Hormone treatment, are screened for trial eligibility.
Once a child is eligible for the OraGrowtH210 Trial, the study will last 24 months and clinic/office visits are required.
The randomized trial is designed for around 80 participants with clinical sites in the United States and other countries.
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Important Information – At the doses tested previously in the Merck Trials, LUM-201 was generally well-tolerated in children with the most commonly reported adverse events being digestive systems events, including appetite increase. Mild elevations in liver enzymes without accompanying changes in bilirubin were also reported.
Watch the video to learn about the OraGrowtH210 Trial
Watch the video to learn about LUM-201 ibutamoren
About the Sponsor
Lumos Pharma is passionately focused on developing therapeutics for rare diseases.
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Rare disease patients and their caretakers inspire us to persevere and continue to advance the development of potential therapies to treat rare diseases. We are honored to work on collaborative projects such as increasing disease awareness, enabling better diagnostic modalities and access, and providing education and services to support patient and healthcare communities.
We are connected globally and proudly based in Austin, Texas and Ames, Iowa.
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