Somapacitan for Growth Hormone Deficiency in Children (REAL 9 Trial)
Palo Alto (17 mi)Age: < 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Novo Nordisk A/S
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing somapacitan, a new growth hormone medicine, in children who have low levels of growth hormone. These children include those born small for their age or with conditions like Turner syndrome, Noonan syndrome, or idiopathic short stature. Somapacitan is given as an injection to help them grow better. Somapacitan is a long-acting growth hormone derivative developed for periodic administration, already approved for use in adult GH deficiency in the USA and Japan.
What data supports the idea that Somapacitan for Growth Hormone Deficiency in Children is an effective drug?The available research shows that Somapacitan, a once-weekly drug, is effective for treating children with Growth Hormone Deficiency. Studies indicate that it is well-tolerated and provides effective growth hormone replacement. Specifically, the REAL4 trial demonstrated that children receiving Somapacitan experienced positive outcomes over a two-year period, and it was effective when children switched from daily growth hormone treatments to this weekly option. This suggests that Somapacitan is a convenient and effective alternative to daily treatments.12357
Is the drug Somapacitan a promising treatment for growth hormone deficiency in children?Yes, Somapacitan is a promising drug for treating growth hormone deficiency in children. It is a long-acting growth hormone that can be given once a week instead of daily, making it more convenient for children and their families. Studies show it is effective and well-tolerated, which means it works well and is safe for use.12367
What safety data is available for Somapacitan in treating growth hormone deficiency?Somapacitan has been evaluated in several studies for its safety and efficacy. It has been found to be well-tolerated in children with growth hormone deficiency in the Phase 3 REAL4 trial. Additionally, Phase I trials have shown it to be well-tolerated in both children and adults, including those with growth hormone deficiency. These studies support its use as a once-weekly treatment.23457
Do I need to stop my current medications to join the trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or high-dose inhaled glucocorticoids, you may not be eligible. It's best to discuss your specific medications with the study doctor.
Eligibility Criteria
This trial is for children aged 10-18 with Turner Syndrome, Noonan Syndrome, or born small for gestational age. They must have open growth plates and a specific height deficit. Children can't join if they have significant health issues affecting growth, diabetes, cancer history, or need certain steroid treatments.Inclusion Criteria
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.
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.
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 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's bone age is not more than 2 years behind their actual age and they haven't started GH treatment.
I am a child with SGA, aged 11-18 if male, or 10-18 if female.
My child has Noonan Syndrome, confirmed by clinical diagnosis or genetic test, and hasn't received growth hormone treatment.
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.
Exclusion Criteria
My child has diabetes or high blood sugar levels.
My child has a condition that could affect their growth.
My child has a condition that could affect their growth.
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.
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.
Treatment Details
The study tests Somapacitan—a new once-weekly injectable growth hormone treatment—over three years to see how safe it is and how well it helps these children grow. Participants will learn to self-inject the medication at home.
1Treatment groups
Experimental Treatment
Group I: SomapacitanExperimental Treatment1 Intervention
Participants will receive Somapacitan for 26-week main phase followed by 130-week extension phase.
Somapacitan is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Sogroya for:
- Growth hormone deficiency in adults
- Growth hormone deficiency in children aged 3 years and above, and adolescents
🇺🇸 Approved in United States as Sogroya for:
- Replacement of endogenous growth hormone in adults with growth hormone deficiency
Find a clinic near you
Research locations nearbySelect from list below to view details:
Childrens National Medical CtrWashington, United States
Univ of AL at Birmingham_BRMBirmingham, AL
Sutter Valley Med Fdt Ped EndoSacramento, CA
Rocky Mt Ped and EndoCentennial, CO
More Trial Locations
Loading ...
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
References
Nonclinical pharmacokinetic and pharmacodynamic characterisation of somapacitan: A reversible non-covalent albumin-binding growth hormone. [2018]Somapacitan is an albumin-binding growth hormone derivative intended for once weekly administration, currently in clinical development for treatment of adult as well as juvenile GH deficiency. Nonclinical in vivo pharmacological characterisation of somapacitan was performed to support the clinical trials. Here we present the pharmacokinetic and pharmacodynamic effects of somapacitan in rats, minipigs, and cynomolgus monkeys.
Pharmacokinetics and Pharmacodynamics of Once-Weekly Somapacitan in Children and Adults: Supporting Dosing Rationales with a Model-Based Analysis of Three Phase I Trials. [2020]Somapacitan, a long-acting growth hormone (GH) derivative, has been well-tolerated in children with GH deficiency (GHD) and adults (healthy and adult GHD), in phase I, single- and multiple-dose trials, respectively, and has pharmacokinetic and pharmacodynamic properties supporting a once-weekly dosing regimen.
Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan. [2021]Somapacitan is a long-acting growth hormone (GH) in development for once-weekly treatment of GH deficiency (GHD). Optimal monitoring of insulin-like growth factor-I (IGF-I) levels must account for weekly IGF-I fluctuations following somapacitan administration.
Effect of Kidney or Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Somapacitan: Two Open-Label, Parallel-Group Trials. [2021]Somapacitan is a long-acting growth hormone (GH) derivative being developed for once-weekly dosing in patients with GH deficiency (GHD). Our objective was to evaluate the impact of kidney or hepatic impairment on somapacitan exposure in adults.
Weekly Somapacitan is Effective and Well Tolerated in Children With GH Deficiency: The Randomized Phase 3 REAL4 Trial. [2023]Somapacitan, a once-weekly reversible albumin-binding GH derivative, is evaluated in children with GH deficiency (GHD).
Weekly Somapacitan in GH Deficiency: 4-Year Efficacy, Safety, and Treatment/Disease Burden Results From REAL 3. [2023]Growth hormone deficiency (GHD) in children is currently treated with daily injections of GH, which can be burdensome for patients and their parents/guardians. Somapacitan is a GH derivative in development for once-weekly treatment of GHD.
Effective GH Replacement With Somapacitan in Children With GHD: REAL4 2-year Results and After Switch From Daily GH. [2023]Somapacitan is a long-acting GH derivative for treatment of GH deficiency (GHD).