OraGrowtH Trials:
Oral LUM-201
for children with
Growth Hormone Deficiency (GHD)
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OraGrowtHTrials is a clinical trial program involving an oral (by mouth) investigational drug, called LUM-201, for pediatric GHD.
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This investigational drug is a capsule filled with LUM-201 minitablets. It can be taken by swallowing the whole capsule, opening the capsule and swallowing the enclosed minitablets with water, or mixing and consuming the minitablets with apple sauce, yogurt or banana puree.
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LUM-201 is a small molecule that is a growth hormone secretagogue. It stimulates and modulates a person’s natural production and secretion of growth hormone (GH).
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It is different from the currently approved injections of recombinant human growth hormone (rhGH) for pediatric GHD.
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If you are interested in learning more about the OraGrowtH Phase 3 Trial, please contact the Sponsor at the contact details located below.
What is the purpose of the clinical trial?
Multiple phase 2 trials studying LUM-201 (example, OraGrowtH210 Trial) support advancing LUM-201 into a phase 3 trial.
The OraGrowtH Phase 3 Trial studies if LUM-201 will help in the treatment of pediatric GHD and how safe it is to use in children.
The trial will compare two randomized groups of children receiving either the investigational drug,
LUM-201, or a placebo (an inactive substance that serves as a control to see if the investigational drug works better than placebo).
Both groups will take a capsule with minitablets that look identical (this is called the study drug) and your doctor will not know if it is LUM-201 or the placebo. This is called a blinded, randomized controlled study.
Who can participate in the clinical trial?
Children who have not been treated for growth hormone deficiency (GHD) as well as other criteria.
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Girls aged 3 years old to less than or equal to 10 years old
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Boys aged 3 years old to less than or equal to 11 years old
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There are no fees to participate in the trial and travel expenses can be reimbursed.
What will happen in the clinical trial?
Children will be evaluated to see if they meet the criteria to participate (eligibility) in the trial.
Once this step has been completed and the child has been “randomized” to either take the investigational drug or placebo, participants will take the oral study drug once-a-day for 12 months.
Participants can expect to have study visits where their doctor will perform examinations that will measure their height and other body measurements, take blood samples as well as other tests.
After completing the 12-month Phase 3 study, all eligible children will be offered (free of charge) up to 3 years of treatment with oral LUM-201 in the Long Term Extension Study.
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The OraGrowtH Phase 3 Trial is 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)
The sponsor of this research study is Lumos Pharma LLC and the NCT Identifier Number of the Trial is NCT06948214.
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IMPORTANT INFORMATION: LUM-201 has a favorable investigational safety profile to date. LUM-201 was generally well-tolerated in children with the most commonly reported adverse events being increased appetite, pain in extremity and arthralgia. No meaningful safety signals have been observed in laboratory values, adverse events data, or in EKG values to date- Phase 2 Trials OraGrowtH210 and 212 Safety Data as of March 2024 cut-off date
A phase 3 trial represents a major final test for a new drug or treatment before it might become approved for market, after regulatory review.
https://www.fda.gov/patients/drug-development-process/step-3-clinical-research#phases
For more information about the OraGrowtH Phase 3 Trial, click below to be transferred to the website called “www.clinicaltrials.gov”, managed by the US Department of Health and Human Services.
Watch the video to learn about the
mechanism of action of
LUM-201 (ibutamoren mesylate)
About the Sponsor
Lumos Pharma LLC is passionately focused on developing therapeutics for rare diseases and devastating disease care through persistent patient-focused therapeutic innovation.
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Patients and their caretakers inspire us to persevere and continue to advance the development of potential therapies to treat rare diseases and devasting disease care. 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.
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We are connected globally and proudly based in Austin, Texas and Ames, Iowa.
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For more information about The OraGrowtH Phase 3 Trial, please contact us at clinical.trials@lumos-pharma.com
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