What side effects are associated with this type of intervention?

Common treatments for Growth Hormone Deficiency (GHD) include daily injections of growth hormone analogs like Norditropin and weekly injections like somapacitan. Known side effects of these treatments can include injection site reactions, such as pain, redness, and swelling. Systemic side effects may include headaches, muscle pain, joint stiffness, and increased risk of diabetes. Some patients may also experience fluid retention, leading to swelling in the extremities. It is important to monitor for these side effects and discuss any concerns with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for Growth Hormone Deficiency (GHD), primarily involving daily administration of recombinant human growth hormone (rhGH) analogs such as Norditropin®, Humatrope®, and Genotropin®. These treatments aim to supplement the deficient growth hormone in children and adults. Recently, there has been interest in developing longer-acting growth hormone analogs to reduce the frequency of administration. Somapacitan, a growth hormone analog administered weekly, is currently being studied as a potential alternative to daily treatments, offering a more convenient option for patients.

What other types of research exist?

As of 2024, promising novel alternatives to Somapacitan for Growth Hormone Deficiency patients include long-acting growth hormone analogs such as Lonapegsomatropin (administered weekly) and TransCon hGH (administered weekly). These alternatives are designed to improve patient compliance and maintain stable growth hormone levels, similar to Somapacitan.

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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 from baseline (week 0) to visit 7 (week 52)

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a new weekly growth hormone medicine, somapacitan, in children who lack enough growth hormone. The goal is to see if somapacitan works well and is safe. The study will last several years with regular clinic visits. Somapacitan is intended for once weekly administration for treatment of both adults and children with growth hormone deficiency.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (week 0) to visit 7 (week 52)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (week 0) to visit 7 (week 52)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to visit 7 (week 52) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Height Velocity: In-trial Observation Period

Height Velocity: On-treatment Observation Period

Secondary study objectives

Change in Bone Age

Change in Fasting Plasma Glucose (FPG) at Week 52

Change in Glycated Haemoglobin (HbA1c) at Week 52

+6 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 9Eligibility criteria met

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.