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Growth Hormone

Somapacitan vs Norditropin for Growth Disorders (REAL 8 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 ISS: Prepubertal children: Boys: Age above or equal to 2 years and 26 weeks and below 11.0 years at screening. Testis volume below 4 mL
Prepubertal children: Boys: Age above or equal to 2 years and 26 weeks and below 11.0 years at screening. Testis volume below 4 mL
Must not have
Children requiring inhaled glucocorticoid therapy at a dose greater than 400 µg/day of inhaled budesonide or equivalent for longer than 4 consecutive weeks within the last 12 months prior to screening
Current treatment with sex hormones or aromatase inhibitors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening (visit 1) to visit 15 (week 156)
Awards & highlights

Summary

This trial is testing a new growth hormone against a current one to see if it's more effective in children with Turner Syndrome, Noonan Syndrome, Idiopathic Short Stature, or who were born small and stay small.

Who is the study for?
This trial is for children who were born small and remain small, or have Turner Syndrome, Noonan Syndrome, or idiopathic short stature. They must not have had growth-promoting therapy before and meet specific criteria related to age, puberty status, BMI, and height. Children with certain medical conditions or on conflicting medications are excluded.Check my eligibility
What is being tested?
The study compares somapacitan (a new medicine given once a week) with Norditropin® (an existing treatment taken daily). Over three years, participants will either receive somapacitan the whole time or start with Norditropin® for one year followed by somapacitan for two years. The assignment of treatments is random.See study design
What are the potential side effects?
While the side effects are not detailed in this summary, common side effects of growth hormone therapies can include injection site reactions, headaches, muscle pain, joint stiffness and hypothyroidism. Long-term safety profiles will be closely monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My son is between 2.5 and 11 years old with small testes.
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My son is between 2.5 and 11 years old with small testes.
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I have not used growth-promoting treatments like growth hormone.
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For girls with ISS: 2 years and 26 weeks to 10 years old, no breast development, and specific bone age. For boys with ISS: up to 12 years old with specific bone age. Height at least 2.5 standard deviations below the average for age and sex. Also, a specific growth hormone test result is needed.
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I was born smaller than the average for my gestational age.
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My child has been diagnosed with Noonan Syndrome.
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My BMI is below the 95th percentile for my age, according to CDC charts.
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I have Turner Syndrome confirmed by a specific blood test.
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My thyroid hormone therapy has been stable for the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My child has been on high-dose asthma medication for more than a month in the past year.
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I am currently taking sex hormones or aromatase inhibitors.
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I haven't taken steroids for inflammation for more than 2 weeks in the last 3 months.
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I have or had another type of cancer, brain tumor, or brain cyst.
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My child has NS or a related disorder and hasn't been stable on a gluten-free diet for the past year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening (visit 1) to visit 15 (week 156)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening (visit 1) to visit 15 (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
Height velocity 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 bone age for ISS
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SomapacitanExperimental Treatment1 Intervention
Participants will receive Somapacitan for 156 weeks
Group II: Norditropin®Active Control1 Intervention
Participants will receive Norditropin® for 52 weeks (main phase) and Somapacitan for 104 weeks (extension phase)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Somapacitan
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Growth hormone therapy, such as somapacitan, stimulates the liver to produce insulin-like growth factor 1 (IGF-1), which promotes bone growth and increases muscle mass. This mechanism is vital for patients with Small for Gestational Age (SGA), Turner Syndrome, Noonan Syndrome, and Intrauterine Growth Restriction (IUGR) as these conditions often lead to short stature and delayed growth. By enhancing growth and development, growth hormone therapy helps these patients achieve a height closer to the average for their age and sex, thereby improving their overall health and quality of life.

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,525 Previous Clinical Trials
2,419,337 Total Patients Enrolled
Clinical Transparency dept. 2834Study DirectorNovo Nordisk A/S
36 Previous Clinical Trials
522,726 Total Patients Enrolled

Media Library

Norditropin® (Growth Hormone) Clinical Trial Eligibility Overview. Trial Name: NCT05330325 — Phase 3
~0 spots leftby Aug 2024