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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening (visit 1) to visit 15 (week 156)

Awards & highlights

REAL 8 Trial 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.

REAL 8 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My son is between 2.5 and 11 years old with small testes.

Select...

My son is between 2.5 and 11 years old with small testes.

Select...

I have not used growth-promoting treatments like growth hormone.

Select...

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.

Select...

I was born smaller than the average for my gestational age.

Select...

My child has been diagnosed with Noonan Syndrome.

Select...

My BMI is below the 95th percentile for my age, according to CDC charts.

Select...

I have Turner Syndrome confirmed by a specific blood test.

Select...

My thyroid hormone therapy has been stable for the last 3 months.

REAL 8 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening (visit 1) to visit 15 (week 156)

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

REAL 8 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

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor

1,514 Previous Clinical Trials

2,414,669 Total Patients Enrolled

Clinical Transparency dept. 2834Study DirectorNovo Nordisk A/S

36 Previous Clinical Trials

522,607 Total Patients Enrolled

Media Library

Norditropin® (Growth Hormone) Clinical Trial Eligibility Overview. Trial Name: NCT05330325 — Phase 3

Frequently Asked Questions

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

Are patients currently being enrolled in this trial?

"That is accurate. The clinical trial, which began recruiting on 8/10/2022, is still ongoing and looking for 399 patients at 35 different sites."

Answered by AI

Is this clinical trial popular in Canada?

"The trial is currently being conducted at 35 sites. These include locations in Cincinnati, Morristown and Washington as well as 32 other locations. If you are considering enrolling, it would be most convenient to select a site near you to limit travel requirements."

Answered by AI

Are there long-term repercussions of taking Somapacitan?

"Somapacitan is classified as a Phase 3 trial medication, which means that while there is some evidence of its efficacy, multiple rounds of safety testing have been conducted. We feel confident assigning it a score of 3."

Answered by AI

Are young people within the age range of this trial able to participate?

"Qualified applicants that meet the inclusion criteria for this clinical trial fall within the age range of 2 to 10 years old. Out of the total number of medical trials, 387 are geared towards children and 1032 are intended for patients over 65 years old."

Answered by AI

How many individuals are being trialed with this medication?

"The clinical trial is still ongoing and actively recruiting participants, as indicated by the information found on clinicaltrials.gov. This study was originally posted on 8/10/2022 and was last edited on 11/8/2022. In total, the study needs 399 participants from 35 different sites."

Answered by AI

Who meets the requirements to participate in this research project?

"Up to 399 children with Noonan syndrome aged 2-10 may be admitted into this study, so long as they meet the following inclusion criteria: Informed consent from a parent or legal guardian, child assent where appropriate, no prior exposure to growth hormone therapy or other similar interventions, born small for gestational age according to national standards, testis volume below 4 mL, impaired height as defined by CDC standards, etc."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow

2022. "A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05330325.

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