LUM-201 for Growth Hormone Deficiency
(OraGrowtH211 Trial)

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Lumos Pharma

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This is a multi-national trial. The trial aims to study the long-term safety of LUM-201 in subjects with Idiopathic Pediatric Growth Hormone Deficiency (iPGHD). This study will also assess pharmacodynamics and efficacy response to therapy with LUM-201.

Eligibility Criteria

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.

Inclusion Criteria

You were part of a previous study for pediatric LUM-201 GHD treatment and completed at least the 12-month visit. If you meet all other requirements, you may be able to continue the treatment.

Parent/caregiver must sign the informed consent, and the subject must sign the assent, as applicable.

Exclusion Criteria

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

Medical or genetic condition that, in the opinion of the PI and/or MMs, adds unwarranted risk to the use of LUM-201

Participant Groups

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.

1Treatment groups

Experimental Treatment

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