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Hormone Therapy

LUM-201 for Growth Hormone Deficiency (OraGrowtH211 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 day 1 to month 36
Awards & highlights

Summary

This trial looks at the safety and effectiveness of a drug to help kids with growth hormone deficiency.

Who is the study for?
This trial is for children with Idiopathic Pediatric Growth Hormone Deficiency who have already been part of a previous LUM-201 study. They must have completed at least 12 months in that study and be cleared to continue treatment. Children with conditions that add risk or those on certain long-term medications affecting LUM-201 metabolism cannot participate.
What is being tested?
The trial is testing the long-term safety of a drug called LUM-201 in children with growth hormone deficiency. It will also look at how the body responds to the drug over time and its effectiveness in promoting growth.
What are the potential side effects?
While specific side effects are not listed, they may include reactions related to growth hormone treatments such as joint pain, headaches, muscle pain, and issues with insulin resistance. Long-term safety monitoring aims to identify any additional side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to month 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to month 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of treatment-emergent adverse events
Secondary study objectives
Annualized Height Velocity (AHV) achieved by daily dosing 1.6mg/kg of LUM-201
Change in Bone Age (BA)
Change in Weight SDS
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: LUM-201 (1.6 mg/kg/day)Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

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

Media Library

LUM-201 (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05796440 — Phase 2
Human Growth Hormone Deficiency Research Study Groups: LUM-201 (1.6 mg/kg/day)
Human Growth Hormone Deficiency Clinical Trial 2023: LUM-201 Highlights & Side Effects. Trial Name: NCT05796440 — Phase 2
LUM-201 (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05796440 — Phase 2
~40 spots leftby Mar 2028
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