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Growth Hormone Medicine

Somapacitan for Growth Hormone Deficiency in Children (REAL 9 Trial)

Phase 3
Recruiting
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Applicable to children with SGA: Open epiphyses; bone age < 14 years for females and < 16 years for males
Applicable to children with TS: Confirmed diagnosis of TS by 30-cell (or more) lymphocyte chromosomal analysis or confirmation of TS and TS mosaicism using comparative genomic hybridization (CGH)-array for GH treatment naïve participants
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to week 156
Awards & highlights

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.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects of Somapacitan are not detailed in the provided information but may be similar to other growth hormones: pain at injection site, headache, muscle pain, and possible impact on blood sugar levels.

REAL 9 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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).
Select...
My child has Turner Syndrome confirmed by specific genetic tests and hasn't started growth hormone treatment.
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My child has open growth plates and is under the age limit for their gender.
Select...
My child is significantly shorter than other kids their age and has not received growth hormone treatment.
Select...
I am a child within the age range required for the study.
Select...
I am a child with NS, aged 11-18 if male, or 10-18 if female.
Select...
My child has been diagnosed with Turner Syndrome.
Select...
I was born smaller than the average for my gestational age.
Select...
My child's growth plates are still open, and their bone age is under the limit for their gender.
Select...
My child is significantly shorter than other kids their age and has not received growth hormone treatment.
Select...
I am a girl aged between 10 and 18 years.
Select...
My child's bone age is not more than 2 years behind their actual age and they haven't started GH treatment.
Select...
I am a child with SGA, aged 11-18 if male, or 10-18 if female.
Select...
My child's growth hormone levels are normal, as tested within the last 18 months.
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My child has Noonan Syndrome, confirmed by clinical diagnosis or genetic test, and hasn't received growth hormone treatment.
Select...
My child has been diagnosed with Noonan Syndrome.
Select...
My child has Turner syndrome, is still growing, and meets the age criteria for bone development.
Select...
My child is significantly shorter than average for their age and sex, and has not received growth hormone treatment.

REAL 9 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to week 156
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to week 156 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of adverse events (AEs) reported separately for small for gestational age (SGA), Turner syndrome (TS), Noonan syndrome (NS) and idiopathic short stature (ISS)
Secondary outcome measures
Change in Height Velocity SDS reported separately for SGA, TS, NS and ISS
Change in Height standard deviation scores (SDS) reported separately for SGA, TS, NS and ISS
Change in insulin-like growth factor 1 (IGF-1) SDS reported separately for SGA, TS, NS and ISS
+5 more

REAL 9 Trial Design

1Treatment groups
Experimental Treatment
Group I: SomapacitanExperimental Treatment1 Intervention
Participants will receive Somapacitan for 26-week main phase followed by 130-week extension phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Somapacitan
2017
Completed Phase 1
~80

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,513 Previous Clinical Trials
2,414,981 Total Patients Enrolled
13 Trials studying Turner Syndrome
29,701 Patients Enrolled for Turner Syndrome
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
105 Previous Clinical Trials
139,741 Total Patients Enrolled

Media Library

Somapacitan (Growth Hormone Medicine) Clinical Trial Eligibility Overview. Trial Name: NCT05723835 — Phase 3
Turner Syndrome Research Study Groups: Somapacitan
Turner Syndrome Clinical Trial 2023: Somapacitan Highlights & Side Effects. Trial Name: NCT05723835 — Phase 3
Somapacitan (Growth Hormone Medicine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05723835 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI
~14 spots leftby Nov 2024