What side effects are associated with this type of intervention?

Common treatments for Human Growth Hormone Deficiency (GHD) include recombinant human growth hormone (rhGH) therapy and agents that stimulate endogenous growth hormone production, such as LUM-201. Known side effects of rhGH therapy can include joint and muscle pain, swelling due to fluid retention, insulin resistance, and increased risk of diabetes. Treatments like LUM-201, which stimulate the body's own production of growth hormone, may have a different side effect profile, potentially including headaches, nausea, and increased cortisol levels. It is important to monitor these side effects closely in clinical settings.

What prior FDA approvals exist?

The FDA has approved several treatments for Human Growth Hormone Deficiency (GHD), primarily focusing on recombinant human growth hormone (rhGH) therapies such as somatropin. These treatments involve daily injections to supplement the body's deficient hormone levels. LUM-201, currently under investigation, represents a novel approach by stimulating the body's endogenous production of growth hormone, potentially offering an alternative to daily rhGH injections. This method aims to enhance the natural growth hormone secretion, which could improve adherence and outcomes for patients with GHD.

What other types of research exist?

Promising novel alternatives to LUM-201 for treating Human Growth Hormone Deficiency (GHD) include vosoritide, a C-type natriuretic peptide analogue, which has shown efficacy in increasing growth velocity in children with achondroplasia. Additionally, postnatal soluble FGFR3 therapy has demonstrated potential in rescuing achondroplasia symptoms and restoring bone growth in preclinical studies. These therapies represent innovative approaches that could be considered for GHD treatment in the near future.

← Back to Search

Growth Hormone Secretagogue Receptor Agonist

LUM-201 for Human Growth Hormone Deficiency (OraGrowtH213 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

Be younger than 18 years old

Must not have

Has planned or is receiving current long-term treatment with medications known to act as substrates, inducers, or inhibitors of the cytochrome system CYP3A4 that metabolizes LUM-201

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the effects of LUM-201, an oral medicine, in children with growth hormone deficiency who have already been treated with growth hormone therapy. The medicine helps their bodies produce more growth hormone to aid in their growth.

Who is the study for?

This trial is for children with growth hormone deficiency who have finished a previous 12-month treatment in the LUM-201-01 study. They must have consent from a parent or caregiver, and if old enough, give their own assent to participate. Children cannot join if they take other medications affecting growth or pose extra risks as determined by the study's lead researcher.

What is being tested?

The trial is testing LUM-201 on children with idiopathic growth hormone deficiency to see how it affects their growth after previously being treated with daily rhGH. It's an international study following up on earlier research to measure continued response.

What are the potential side effects?

While specific side effects of LUM-201 are not listed here, common ones related to growth hormone treatments may include joint pain, swelling, muscle pain, and headaches. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am on long-term medication that affects how my body processes certain drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Annualized height velocity (AHV) measured as standing height with stadiometer

Secondary study objectives

Change in BMI

Change in BMI SDS

Change in Bone Age

+8 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: LUM-201 (3.2 mg/kg/day)Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LUM-201

2020

Completed Phase 2

~90

0 / 1Eligibility 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

The most common treatments for Human Growth Hormone Deficiency (GHD) include recombinant human growth hormone (rhGH) therapy and newer agents like LUM-201 that stimulate endogenous growth hormone production. rhGH therapy involves daily injections of synthetic growth hormone to directly replace the deficient hormone, promoting growth and metabolic functions. LUM-201, on the other hand, works by stimulating the body's own pituitary gland to produce and release more growth hormone. This endogenous stimulation is crucial as it can potentially lead to more natural growth patterns and fewer side effects compared to direct hormone replacement. For GHD patients, these treatments are vital as they help achieve normal growth, improve body composition, and enhance overall quality of life.