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Could a daily pill replace growth hormone shots for kids?

NCT ID NCT06948214

Disease control Sponsor: Lumos Pharma Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 22 times

Summary

This study tests an oral medication called LUM-201 for children with growth hormone deficiency who have never been treated before. The goal is to see if taking a pill every day for 12 months can improve growth rate compared to a placebo. The study involves 150 prepubertal children aged 3 to 11 years old.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 11 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects must be naïve to treatment and prepubertal * Subjects must have a maximal GH response of \< 10 ng/mL from 2 prior GH stimulation tests conducted within the preceding 12 months * Impaired height defined as ≥ 2.0 standard deviations (SDs) below the mean height for chronological age and sex * Morning or random cortisol level of ≥ 7.0 μg/dL * ≥ 3.0 years and age ≤ 10.0 years for girls and ≤ 11.0 years for boys * Baseline height velocity (HV) based on ≥ 6 months of growth assessments \< 25th percentile for age and sex * Bone Age delay of ≥ 12 months compared to the chronological age * In girls, have genetic testing results to rule out Turner syndrome. If SHOX genetic testing results are available, they need to be negative. * Have normal thyroid function. Subjects diagnosed with hypothyroidism must have documented successful treatment for at least 3 months prior to Day 1 * Baseline IGF-1 standard deviation score (SDS) ≤ -1.0 Exclusion Criteria: * Any medical or genetic condition which, in the opinion of the Investigator or Medical Monitor (MM), can be an independent cause of short stature and/or limit the response to exogenous growth factor treatment. * Arm span to height ratio \> 2 SDs below the mean for age and sex * A medical or genetic condition that, in the opinion of the Investigator and/or MM, adds unwarranted risk to use of LUM-201 * Use of any medication that, in the opinion of the Investigator and/or MM, can independently cause short stature or limit the response to exogenous growth factors * Current inflammatory diseases requiring systemic corticosteroid treatment for \> 2 consecutive weeks within the last 3 months prior to the Screening Visit * Use of hormone replacement therapy for any hormone deficiency other than thyroid deficiency * Any ECG at the Screening Visit noted to have a clinically significant abnormality, as confirmed by the MM * Any subjects suspected of having past or present intracranial tumor growth as confirmed by brain imaging prior to the Screening or Day 1 Visit * Any subject suspected of having intracranial hypertension (IH) as confirmed by fundoscopy and other assessments * Any subject with serum alanine transaminase (ALT), aspartate transaminase (AST), or total bilirubin \> upper limit of normal (ULN) * Suspicion of absent pituitary function as evidenced by a maximal stimulated GH ≤ 3.0 ng/mL on any prior standard of care GH stimulation test completed within 12 months * Body weight ≤ 14.0 kg * BMI \< -2 or \> +2 SDs for age and sex based on WHO standards * Birth weight for gestational age \< 3rd percentile based on WHO standards * Treatment with medications known to be moderate or strong inhibitors or strong inducers of cytochrome P450 (CYP) 3A/4 * History of spinal, cranial, or total body irradiation * Attention deficit hyperactivity disorder (ADHD) diagnosis

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Conditions

The condition(s) this trial relates to.

isolated congenital growth hormone deficiency pituitary dwarfism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Growth hormone deficiency (GHD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    51 sites in 8 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Lumos Pharma Investigational Site

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Madera, California, 93636, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Orange, California, 92868, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Sacramento, California, 95821, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    San Diego, California, 92123, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Centennial, Colorado, 80112, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Greenwood Village, Colorado, 80111, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Hollywood, Florida, 33021, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Miami, Florida, 33155, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Orlando, Florida, 32806, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Tallahassee, Florida, 32308, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    New Orleans, Louisiana, 70118, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Minneapolis, Minnesota, 55454, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Kansas City, Missouri, 64108, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Las Vegas, Nevada, 89113, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Staten Island, New York, 10306, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Columbia, South Carolina, 29203, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Amarillo, Texas, 79106, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Corpus Christi, Texas, 78411, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    San Antonio, Texas, 78207, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    Seattle, Washington, 98105, United States

  • Lumos Pharma Investigational Site

    RECRUITING

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Lumos Pharma Investigational Site

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • Lumos Pharma Investigational Site

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Lumos Pharma Investigational Site

    RECRUITING

    Parkville, Victoria, 3052, Australia

  • Lumos Pharma Investigational Site

    RECRUITING

    Santiago, Santiago Metropolitan, 8320000, Chile

  • Lumos Pharma Investigational Site

    RECRUITING

    Mumbai, Maharashtra, 400012, India

  • Lumos Pharma Investigational Site

    RECRUITING

    Nashik, Maharashtra, 422002, India

  • Lumos Pharma Investigational Site

    RECRUITING

    Jaipur, Rajasthan, 302004, India

  • Lumos Pharma Investigational Site

    RECRUITING

    Madurai, Tamil Nadu, 625020, India

  • Lumos Pharma Investigational Site

    RECRUITING

    Chandigarh, 160012, India

  • Lumos Pharma Investigational Site

    RECRUITING

    Auckland, 1142, New Zealand

  • Lumos Pharma Investigational Site

    RECRUITING

    Wellington, 6242, New Zealand

  • Lumos Pharma Investigational Site

    RECRUITING

    Bangkok Noi, Bangkok, 10700, Thailand

  • Lumos Pharma Investigational Site

    RECRUITING

    Pathumwan, Bangkok, 10330, Thailand

  • Lumos Pharma Investigational Site

    RECRUITING

    Muang, Changwat Khon Kaen, 40002, Thailand

  • Lumos Pharma Investigational Site

    RECRUITING

    Hat Yai, Changwat Songkhla, 90110, Thailand

  • Lumos Pharma Investigational Site

    RECRUITING

    Muang, Chiang Mai, 50200, Thailand

  • Lumos Pharma Investigational Site

    RECRUITING

    Liverpool, England, L12 2AP, United Kingdom

  • Lumos Pharma Investigational Site

    RECRUITING

    London, England, E1 1BB, United Kingdom

  • Lumos Pharma Investigational Site

    RECRUITING

    London, England, W1G9AB, United Kingdom

  • Lumos Pharma Investigational Site

    RECRUITING

    Sheffield, England, S10 2TH, United Kingdom

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