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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
Must not have
Children requiring inhaled glucocorticoid therapy at a dose of greater than 400 μg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening
Prior history or presence of malignancy including intracranial tumours
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week -2), week 208
Awards & highlights

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.

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

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 over a month in the past year.
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I have had cancer before, including brain tumors.
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I have been diagnosed with ADHD.
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I haven't taken steroids for inflammation for more than 2 weeks in the last 3 months.

Timeline

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

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

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 deficiency (GHD) treatments, such as somapacitan (a weekly growth hormone analog) and Norditropin® (a daily growth hormone injection), work by supplementing the body's deficient growth hormone levels. These treatments mimic the natural growth hormone, binding to growth hormone receptors and activating signaling pathways that promote growth and development, particularly in bones and muscles. This is crucial for GHD patients as it helps them achieve normal growth patterns, improve metabolic functions, and enhance overall quality of life.
Tissue Distribution and Receptor Activation by Somapacitan, a Long Acting Growth Hormone Derivative.Octreotide and pasireotide (dis)similarly inhibit pituitary tumor cells in vitro.Oral octreotide absorption in human subjects: comparable pharmacokinetics to parenteral octreotide and effective growth hormone suppression.

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,525 Previous Clinical Trials
2,419,536 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
111 Previous Clinical Trials
140,369 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
~32 spots leftby Jul 2025