Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
NCT ID: NCT06948214
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
150 participants
INTERVENTIONAL
2026-01-31
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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LUM-201
LUM-201
1.6 mg/kg/day, administered orally once daily
Placebo
Matched Placebo (Capsules)
Administered orally once daily
Interventions
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LUM-201
1.6 mg/kg/day, administered orally once daily
Matched Placebo (Capsules)
Administered orally once daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
3 Years
11 Years
ALL
No
Sponsors
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Lumos Pharma
INDUSTRY
Responsible Party
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Locations
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Lumos Pharma Investigational Site
Birmingham, Alabama, United States
Lumos Pharma Investigational Site
Sacramento, California, United States
Lumos Pharma Investigational Site
Centennial, Colorado, United States
Lumos Pharma Investigational Site
Greenwood Village, Colorado, United States
Lumos Pharma Investigational Site
Orlando, Florida, United States
Lumos Pharma Investigational Site
Tallahassee, Florida, United States
Lumos Pharma Investigational Site
New Orleans, Louisiana, United States
Lumos Pharma Investigational Site
New Brunswick, New Jersey, United States
Lumos Pharma Investigational Site
Staten Island, New York, United States
Lumos Pharma Investigational Site
Columbia, South Carolina, United States
Lumos Pharma Investigational Site
Corpus Christi, Texas, United States
Lumos Pharma Investigational Site
Seattle, Washington, United States
Countries
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Central Contacts
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Other Identifiers
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LUM-201-10
Identifier Type: -
Identifier Source: org_study_id
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