What side effects are associated with this type of intervention?

Common treatments for Human Growth Hormone Deficiency (HGHD) include recombinant human growth hormone (rhGH) therapy and growth hormone-releasing hormone (GHRH) analogs. Side effects of rhGH therapy can include joint and muscle pain, swelling due to fluid retention, insulin resistance, and increased risk of diabetes. Treatments similar to LUM-201, which stimulate growth hormone secretion via the GHRH receptor, may have side effects such as headache, nausea, and injection site reactions. It is important to monitor for these side effects and adjust treatment as necessary under medical supervision.

What prior FDA approvals exist?

The FDA has approved several treatments for Human Growth Hormone Deficiency (HGHD), primarily focusing on recombinant human growth hormone (rhGH) therapies. These include somatropin brands like Genotropin, Humatrope, Norditropin, and others, which directly supplement growth hormone levels in deficient individuals. While LUM-201, which stimulates growth hormone secretion via the GHRH receptor, is currently under investigation, there is limited information on prior FDA approvals for similar GHRH receptor-targeting treatments. Most existing therapies involve direct hormone replacement rather than stimulation of endogenous hormone production.

What other types of research exist?

Promising novel alternatives to LUM-201 for Human Growth Hormone Deficiency patients include: 1) Somapacitan, a long-acting growth hormone analog that requires less frequent dosing. 2) TransCon hGH, a sustained-release prodrug of human growth hormone designed for weekly administration. 3) Gene therapy approaches targeting the underlying genetic causes of HGHD, which are currently under investigation in clinical trials. These alternatives offer potential benefits in terms of efficacy, convenience, and patient adherence.

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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to month 6 and month 18

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LUM-201

2020

Completed Phase 2

~90

0 / 10Eligibility criteria met

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.