Your session is about to expire
← Back to Search
Somapacitan for Growth Hormone Deficiency in Children (REAL 9 Trial)
REAL 9 Trial Summary
This trial evaluates the safety and effectiveness of somapacitan, a new growth hormone medicine, for children with low levels of growth hormone. The trial lasts 3 years, with injections once a week. Participants will be instructed on how to inject at home.
REAL 9 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowREAL 9 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.REAL 9 Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- My child has diabetes or high blood sugar levels.My child is small for their age with growth plates still open and a bone age under 14 (if female) or under 16 (if male).My child has Turner Syndrome confirmed by specific genetic tests and hasn't started growth hormone treatment.My child has open growth plates and is under the age limit for their gender.My child is significantly shorter than other kids their age and has not received growth hormone treatment.My child is suspected or confirmed to have growth hormone deficiency.I am a child within the age range required for the study.I am a child with NS, aged 11-18 if male, or 10-18 if female.My child has been diagnosed with Turner Syndrome.I was born smaller than the average for my gestational age.My child's growth plates are still open, and their bone age is under the limit for their gender.My child has a condition that could affect their growth.My child is significantly shorter than other kids their age and has not received growth hormone treatment.I am a girl aged between 10 and 18 years.My child has a condition that could affect their growth.My child's bone age is not more than 2 years behind their actual age and they haven't started GH treatment.My child has a condition that could affect their growth.I am a child with SGA, aged 11-18 if male, or 10-18 if female.My child has a condition that could affect their growth.I haven't taken steroids for inflammation for more than 2 weeks in the last 3 months.My child's growth hormone levels are normal, as tested within the last 18 months.My child has Noonan Syndrome, confirmed by clinical diagnosis or genetic test, and hasn't received growth hormone treatment.I have or had cancer, including brain tumors.My child has been on high-dose asthma medication for more than a month in the past year.My child has been diagnosed with Noonan Syndrome.My child has Turner syndrome, is still growing, and meets the age criteria for bone development.My child is significantly shorter than average for their age and sex, and has not received growth hormone treatment.
- Group 1: Somapacitan
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are persons aged 80 and under eligible for this research?
"As per the requirements of this clinical trial, only those aged between 10 and 18 will be accepted as viable participants."
Is Somapacitan likely to produce any adverse effects in patients?
"Our team at Power assigned Somapacitan a score of 3 on the safety scale, which is based upon past trials and data that suggest efficacy along with multiple rounds of evidence regarding its safety."
How many Canadian healthcare facilities are trialing this research project?
"Presently, the clinical trial is being held in 5 distinct locations. These are situated in Centennial, Washington and Idaho Falls among other places. It may be helpful to select the closest clinic for your participation if you wish to reduce travel time demands."
Is this research endeavor actively seeking participants?
"The information found on clinicaltrials.gov reveals that this clinical trial is not currently enrolling patients. It was originally published in February 1st 2023 and the last update came at the end of January 29th 2023. Nevertheless, there are 1405 other medical studies actively recruiting participants now."
What qualifications must an individual possess in order to be eligible for this research?
"This trial is seeking 48 participants aged between 10 and 18 that have been diagnosed with Small for Gestational Age, Turner Syndrome, Noonan Syndrome or Intrauterine Growth Restriction. Key criteria include: Born of low birth weight/length (according to national standards) for males 11-18 years old & females 10-18 years old; open epiphyses (bone age < 14 y/o female & 16 y/o male); height at least 2.5 SD below the meanheightfor chronological age & sex according to CDC standards; diagnosis of TS by 30+ cell lymphocyte chromosomal analysis or CGH array confirmation"
Share this study with friends
Copy Link
Messenger