NCT06309979 · BioMarin Pharmaceutical
A Study to Assess Growth in Children With Idiopathic Short Stature
What this study is about
Study 111-903 will generate baseline growth data in children with ISS by collecting growth measurements and other variables of interest.
View original scientific description
Study 111-903 will generate baseline growth data in children with ISS by collecting growth measurements and other variables of interest.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants must be \> 2 years old, and ≤ 14 years old (female) or ≤ 16 years old (males) at the time of signing the informed consent.
- A height assessment corresponding to a height Z-score of ≤ -2.25 SDs in reference to the general population of the same age and sex, as calculated using the Centers for Disease Control and Prevention (CDC) growth chart (https://www.cdc.gov/growthcharts/zscore.htm).
- Participants who have either never received hGH, or who are currently receiving hGH treatment.
- Historic stimulation test result with serum or plasma GH level greater than 10 μg/L.
- Parent(s) or guardian(s) are willing and able to provide written, signed informed consent.
Exclusion criteria
- Diagnosis of systemic disease or condition that may cause short stature, eg renal, neoplastic, pulmonary, cardiac, gastrointestinal, immunologic and metabolic disease. Children with such diagnoses can be considered for inclusion if their condition is well controlled, at the discretion of the Medical Monitor.
- Known presence of one or more pituitary hormone deficiencies
- Bone age advanced over chronological age by more than 3 years.
- For hGH naïve participants, historic stimulation test result with serum or plasma GH level greater than 10 μg/L or serum IGF-1 in the normal range for age (between -1.00 SDs and +2.00 SDs).
- For participants currently on hGH treatment, historic results before GH treatment of stimulation test with serum or plasma GH level greater than 10 μg/L or serum IGF-1 test between -1.00 SDs and +2.00 SDs.
- Have received an investigational product (IP) or investigational medical device for any purpose within 6 months before the Screening visit. .
Where
- Phoenix, Arizona
- Los Angeles, California
- Orange, California
- Sacramento, California
- San Diego, California
- San Francisco, California
- Hartford, Connecticut
- New Haven, Connecticut
- Washington D.C., District of Columbia
- Jacksonville, Florida
- Miami, Florida
- Pensacola, Florida
And 24 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations