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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6
Awards & highlights

OraGrowtH213 Trial Summary

This trial is studying the growth response to a new drug, LUM-201, in children with GHD who have previously been treated with another growth hormone for 12 months.

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.Check my eligibility
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.See study design
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.

OraGrowtH213 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Annualized height velocity (AHV) measured as standing height with stadiometer
Secondary outcome measures
Change in BMI
Change in BMI SDS
Change in Bone Age
+8 more

OraGrowtH213 Trial Design

1Treatment groups
Experimental Treatment
Group I: LUM-201 (3.2 mg/kg/day)Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

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

Media Library

LUM-201 (Growth Hormone Secretagogue Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05250063 — Phase 2
Human Growth Hormone Deficiency Research Study Groups: LUM-201 (3.2 mg/kg/day)
Human Growth Hormone Deficiency Clinical Trial 2023: LUM-201 Highlights & Side Effects. Trial Name: NCT05250063 — Phase 2
LUM-201 (Growth Hormone Secretagogue Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05250063 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned LUM-201 for general use?

"LUM-201 has been evaluated for safety in a Phase 2 trial, so it was given an assessment of 2 on the 1 to 3 scale. No evidence exists verifying efficacy yet."

Answered by AI

Are individuals aged sixty or younger eligible for this research initiative?

"The eligibility criteria for this clinical trial are candidates aged three to thirteen years old."

Answered by AI

Are there any vacancies for volunteers in this trial?

"Information on clinicaltrials.gov states that this investigation is not presently recruiting patients for enrollment. The trial was first listed on February 18th 2022 and last edited in August of the same year, but 24 other studies are actively welcoming new participants at present."

Answered by AI

Am I eligible to take part in this medical experiment?

"This investigation requires 20 participants aged between 3 and 13 with human growth hormone deficiency to sign an informed consent along with their caretaker (where applicable). Moreover, applicants must have completed the prior LUM-201-01 PGHD trial for 12 months daily rhGH treatment; eligibility will be established by the principal investigator."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
North Carolina
How old are they?
18 - 65
What site did they apply to?
Children's National Hospital
University of Virginia Health System
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Having trouble getting insurance to approve growth hormone and would like to see other options in the treatment of GH deficiency (ideally other than daily injections).
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Can we get put on the waiting list if its too soon to qualify?
PatientReceived no prior treatments
~5 spots leftby Feb 2025