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Peptide Hormone

LUM-201 for Growth Hormone Deficiency (OraGrowtH210 Trial)

Phase 2
Waitlist Available
Research Sponsored by Lumos Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At Screening, be ≥ 3.0 years and ≤ 11.0 years for girls and ≤ 12.0 years for boys
Have prepubertal status as evidenced by Tanner Stage I breast development in girls and testicular volume < 4.0 mL in boys
Must not have
Malnutrition as evidenced by medical history or a body weight < 3rd percentile for current height
Evidence or history of an intracranial mass (e.g., pituitary tumor, craniopharyngioma)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to month 6 and month 18
Awards & highlights

Summary

This trial tests a new oral medication, LUM-201, and compares it to standard growth hormone injections in children who don't grow properly due to a lack of growth hormone. LUM-201 aims to help the body make more growth hormone on its own, while the injections provide the hormone directly. LUM-201 is an orally administered medication under development for treatment of pediatric growth hormone deficiency.

Who is the study for?
This trial is for children with Pediatric Growth Hormone Deficiency (PGHD) who are between 3-11 years old for girls and up to 12 for boys, have not received treatment before, and meet specific growth criteria. They must also have normal thyroid function or treated hypothyroidism. Children with other conditions causing short stature or those on certain medications are excluded.
What is being tested?
The OraGrowtH210 Trial is testing LUM-201 against Norditropin®, a standard growth hormone therapy, in children with PGHD. It aims to see if LUM-201 can effectively treat the condition and will use a PEM strategy to identify kids likely to benefit from this new treatment.
What are the potential side effects?
While the trial's description doesn't specify side effects, typical ones associated with growth hormone treatments include injection site reactions, joint pain, muscle pain, headaches, and potential increases in blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a girl aged 3 to 11 years or a boy aged 3 to 12 years.
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I am a child who has not started puberty.
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I have not received any treatment and am not yet going through puberty.
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I am a girl who has been tested and do not have Turner syndrome or a positive SHOX gene test.
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I have been diagnosed with idiopathic growth hormone deficiency.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am undernourished or weigh less than the lowest 3% for my height.
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I have or had a brain tumor.
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I have had radiation therapy to my spine, skull, or whole body.
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My tests show I might have a non-functioning pituitary gland.
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I am not taking any strong medication that affects certain liver enzymes or drug transporters.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to month 6 and month 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to month 6 and month 18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AHV after 6 months on LUM-201 compared to rhGH
Percentage of subjects selected by PEM strategy who meet target growth
Secondary study objectives
Bone Age
Change in BMI
Change in BMI SDS
+9 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: LUM-201 (3.2 mg/kg/day)Experimental Treatment1 Intervention
Group II: LUM-201 (1.6 mg/kg/day)Experimental Treatment1 Intervention
Group III: LUM-201 (0.8 mg/kg/day)Experimental Treatment1 Intervention
Group IV: rhGH (34 µg/kg/day)Active Control1 Intervention

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Human Growth Hormone Deficiency (HGHD) include recombinant human growth hormone (rhGH) therapy and growth hormone-releasing hormone (GHRH) analogs. rhGH therapy involves the direct administration of synthetic growth hormone to stimulate growth and metabolic functions. GHRH analogs, like the one being studied in the LUM-201 trial, stimulate the pituitary gland to release endogenous growth hormone by activating the GHRH receptor. This approach can be beneficial as it promotes a more natural growth hormone secretion pattern, potentially reducing side effects and improving treatment efficacy. For HGHD patients, these treatments are crucial as they help restore normal growth, development, and metabolic functions, significantly improving quality of life.

Find a Location

Who is running the clinical trial?

Lumos PharmaLead Sponsor
4 Previous Clinical Trials
102 Total Patients Enrolled
3 Trials studying Human Growth Hormone Deficiency
102 Patients Enrolled for Human Growth Hormone Deficiency

Media Library

LUM-201 (Peptide Hormone) Clinical Trial Eligibility Overview. Trial Name: NCT04614337 — Phase 2
Human Growth Hormone Deficiency Research Study Groups: LUM-201 (1.6 mg/kg/day), LUM-201 (0.8 mg/kg/day), LUM-201 (3.2 mg/kg/day), rhGH (34 µg/kg/day)
Human Growth Hormone Deficiency Clinical Trial 2023: LUM-201 Highlights & Side Effects. Trial Name: NCT04614337 — Phase 2
LUM-201 (Peptide Hormone) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04614337 — Phase 2
~17 spots leftby Oct 2025