Skip to content

Trial · Interventional

Not yet recruitingPhase 3Registry data

Phase 3 Long Term Safety Extension Study of LUM-201 in Children With Growth Hormone Deficiency

NCTNCT07129759 (opens ClinicalTrials.gov in a new tab)Other idLUM-201-11
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Not yet recruiting
Phase
Phase 3
Enrollment
150 participants (estimated)
Sponsor
Lumos Pharma · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
Not stated
Start
Feb 2027 (estimated)
Primary completion
Feb 2030 (estimated)
Completion
Feb 2030 (estimated)
First posted
19 Aug 2025
Last update posted
8 Jul 2026
Conditions
Growth Hormone Deficiency (GHD)

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20272028202920302031
  1. Ph 3

    Phase 3 Long Term Safety Extension Study of LUM-201 in Children With Growth Hormone Deficiency

    NCT07129759

    est. Feb 2027 to est. Feb 2030

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a Multi-national Trial. The Goal of the Trial is to Offer Subjects Who Complete 12 Months in the LUM-201-10 Phase 3 Trial up to an Additional 36 Months of Treatment of LUM-201 While Evaluating Safety and Tolerability of LUM-201.

Interventions

  • LUM-201Drug

Arms1

  • Experimental

    LUM-201

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. To evaluate the long-term safety and tolerability of LUM-201

    Time frame · Day 1 - Month 36

    Registry description

    * The number of subjects with at least 1 (serious) treatment-related adverse event (TEAE). * The number of subjects with at least 1 suspected unexpected serious adverse reaction. * The number of subjects with clinically significant abnormalities related to trial laboratory tests or electrocardiograms (ECGs). * The number of subjects with at least 1 adverse event of special interest (AESI). * Annual change from baseline in body weight standard deviation score (SDS). * Annual change from baseline in body mass index (BMI) SDS.

Secondary outcomes(2)

  1. To evaluate the long-term effect of LUM-201 on growth.

    Time frame · Day 1 - Month 36

    Registry description

    * Annual height velocity. * Annual change in height standard deviation score (SDS). * Annual change in body mass index (BMI). * Annual change in BMI SDS. * Annual change in bone age (BA)/chronological age (CA) ratio.

  2. To evaluate the long-term effect of LUM-201 on pharmacodynamic (PD) markers.

    Time frame · Day 1 - Month 36

    Registry description

    * Annual change in insulin-like growth factor (IGF)-1 SDS. * Annual change in insulin-like growth binding protein 3 (IGFBP-3) SDS.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 4 Years up to 12 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Parent/caregiver must be willing to provide written informed consent, and the subject must sign the assent, as applicable. * Subject must have successfully completed 12 months of participation in the LUM-201 Phase 3 GHD trial, and be eligible for continuation of treatment, pending all other enrollment criteria are met. * Subject who is sexually active must use an acceptable form of contraception. * Subject must be eligible for the Day 1 visit as confirmed by the Investigator. Exclusion Criteria: * Subject has a medical or genetic condition that, in the opinion of the Investigator and/or MMs, adds unwarranted risk to use of LUM-201. * Pregnancy. * Subject has planned or is receiving current long-term treatment with medications known to prolong the QT interval or act as substrates, inducers, or inhibitors of the cytochrome system cytochrome P450 type 3A4 that metabolizes LUM-201 (see Appendix 6 for list of example medications). Subjects receiving shorter-term (two weeks or less) treatment with these medications should be evaluated on case-by-case basis by the Investigator in consultation with the MMs.

PepBank is a research reference. Talk to a doctor before you use any peptide.