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Hormone Therapy

Weekly Somapacitan vs Daily Norditropin® for Growth Hormone Deficiency (REAL4 Trial)

Phase 3

Waitlist Available

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

Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and gender at screening according to the standards of Center for Disease Control and Prevention

Insulin-like Growth Factor-I (IGF-I) less than -1.0 SDS at screening, compared to age and gender normalized range measured at central laboratory

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week -2), week 208

Awards & highlights

REAL4 Trial Summary

This trial is testing a new once-weekly injectable growth hormone against the current standard of care, which is daily injections, to see if it is effective and safe for children who don't have enough hormone to grow.

Who is the study for?

This trial is for prepubertal children with growth hormone deficiency, who are significantly shorter than average for their age and gender, have slow growth rates, and low levels of IGF-I. They must not have used growth hormone therapy before and should be diagnosed through specific tests. Children with certain diseases affecting growth or taking medications that influence height aren't eligible.Check my eligibility

What is being tested?

The study compares somapacitan (a new medicine given once a week) to Norditropin® (an existing daily treatment) in children lacking sufficient growth hormones. The effectiveness and safety of somapacitan will be evaluated over four years, involving 19 clinic visits and one phone call.See study design

What are the potential side effects?

While the trial description does not specify side effects, typical ones associated with growth hormone treatments may include reactions at the injection site, headaches, muscle pain, joint stiffness, and possible increased risk of diabetes.

REAL4 Trial Eligibility Criteria

Inclusion Criteria

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

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I am significantly shorter than average for my age and gender.

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My IGF-I levels are lower than normal for my age and gender.

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I have never been treated with growth hormone or IGF-I.

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My child is of the appropriate age and shows no signs of puberty.

Select...

I have been diagnosed with growth hormone deficiency in the last year.

REAL4 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week -2), week 208

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week -2), week 208

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week -2), week 208 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: In-trial Observation Period

Height Velocity: On-treatment Observation Period

Secondary outcome measures

Change in Bone Age

Change in FPG at Week 104

Change in FPG at Week 156

+24 more

REAL4 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Somapacitan weeklyExperimental Treatment1 Intervention

Participants will receive somapacitan weekly for 52 weeks (main trial period). Participants completing the main trial period in both the treatment arms ('Somapacitan weekly' and 'Norditropin® daily') will receive somapacitan weekly for 3 years (extension trial period).

Group II: Norditropin® dailyActive Control1 Intervention

Participants will receive Norditropin® daily for 52 weeks (main trial period).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Somapacitan

2017

Completed Phase 1

~80

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor

1,512 Previous Clinical Trials

2,387,829 Total Patients Enrolled

Clinical Reporting Anchor and Disclosure (1452)Study DirectorNovo Nordisk A/S

104 Previous Clinical Trials

103,054 Total Patients Enrolled

Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S

99 Previous Clinical Trials

111,753 Total Patients Enrolled

Media Library

Norditropin® (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03811535 — Phase 3

Growth Hormone Deficiency Research Study Groups: Norditropin® daily, Somapacitan weekly

Growth Hormone Deficiency Clinical Trial 2023: Norditropin® Highlights & Side Effects. Trial Name: NCT03811535 — Phase 3

Norditropin® (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03811535 — Phase 3

Growth Hormone Deficiency Patient Testimony for trial: Trial Name: NCT03811535 — Phase 3

Frequently Asked Questions

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

Does Somapacitan have any dangerous side effects for people?

"Somapacitan is rated as a 3 in terms of safety by our team because it has progressed to Phase 3 clinical trials. This signifies that, not only is there some evidence backing its efficacy, but also that there are multiple rounds of data supporting its safety."

Answered by AI

Could you give me the updated headcount for this experiment?

"This particular research project is not actively looking for any more participants. The study was first posted on May 20th, 2019 and was most recently updated on November 8th, 2022. If you are interested in other studies, there are currently 21 trials seeking patients with hypophysial dwarfism and 35 trials testing Somapacitan that still need subjects."

Answered by AI

How can I get involved in this research?

"Hypophysial dwarfism is a required condition for patients that want to be accepted into this study. In addition, all participants must be between 2 and 11 years old. Right now, the study is looking for around 200 individuals total."

Answered by AI

Are patients over the age of 80 being sought out for this research?

"The target population for this trial are children aged 2-11 years old."

Answered by AI

Are there any current vacancies in this trial for new patients?

"No, this particular study is not currently looking for patients. Although, it is important to note that the trial was last updated on November 8th, 2020 and there are other 56 studies that are actively recruiting right now."

Answered by AI

What indications is Somapacitan approved for?

"Somapacitan is a medication commonly used to treat general surgery patients. Additionally, Somapacitan can be helpful for those struggling with short stature, open epiphyses, and antiretroviral therapy."

Answered by AI

Has research like this been conducted before?

"Somapacitan has a long research history, with the first study being conducted in 2005. The most recent Phase 3 approval happened in 35 different cities across 45 countries. Currently, there are 170 active studies concerning Somapacitan."

Answered by AI

If there are several locations testing this treatment, where specifically are they located?

"Enrollment for this research is currently happening at 29 different locations, which include places like Edmonton, Wilmington and Saint Paul. To make things more convenient for participants, it is best to try and enroll at a location near you."

Answered by AI

Does Somapacitan have a long and effective history?

"As of now, there are 35 Somapacitan clinical trials underway with 14 in Phase 3. While a few of these studies originate from Philadelphia, Pennsylvania, there are 646 research sites for Somapacitan clinical trials globally."

Answered by AI

Who else is applying?

What state do they live in?

North Carolina

New York

What site did they apply to?

Novo Nordisk Investigational Site

Other

What portion of applicants met pre-screening criteria?

Met criteria

Did not meet criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I’m desperate to find a way to help my son reach his full growth potential.

PatientReceived 1 prior treatment

I have secondary adrenal insufficiency caused by surgery to remove a craniopharyngioma.

PatientReceived 1 prior treatment

My son received a GHD diagnosis in January but insurance does not cover any GH treatment. We would like him to start treatment but don't have many financial options right now.

PatientReceived 2+ prior treatments

Recent research and studies

The Journal of Clinical Endocrinology & MetabolismJournal

Weekly Somapacitan Is Effective and Well Tolerated in Children with GH Deficiency: The Randomized Phase 3 REAL4 Trial

Miller, Bradley S, Joanne C Blair, Michael Højby Rasmussen, Aristides Maniatis, Rasmus Juul Kildemoes, Jun Mori, Michel Polak, et al.. 2022. “Weekly Somapacitan Is Effective and Well Tolerated in Children with GH Deficiency: The Randomized Phase 3 REAL4 Trial”. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. doi:10.1210/clinem/dgac513.

clinicaltrials.govStudy

A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)

2019. "A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03811535.

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