LUM-201 for Human Growth Hormone Deficiency

(OraGrowtH213 Trial)

Recruiting at 9 trial locations

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Lumos Pharma

Must not be taking: CYP3A4 medications

Disqualifiers: Medical condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 12 months

18 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Is eligible for study participation as confirmed by the principal investigator (PI)

You must have already finished 12 months of daily rhGH treatment as part of the LUM-201-01 PGHD trial.

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

Exclusion Criteria

Has a medical condition that, in the opinion of the PI and/or MM, adds unwarranted risk to use of LUM-201.

I am not on medication that could affect my growth or response to growth treatments.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Treatment

Participants receive LUM-201 as a daily oral dose each morning for 12 months

12 months

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LUM-201

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

Lumos Pharma

Lead Sponsor

Trials

5

Recruited

180+