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Study on the Effects of Somapacitan and Somatropin in Children with Growth Hormone Deficiency

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying children with a condition known as Growth Hormone Deficiency. This condition occurs when the body does not produce enough growth hormone, which is important for growth and development. The study is comparing two treatments: Somapacitan, which is given once a week, and Norditropin®, which is administered daily. Both treatments are solutions for injection, delivered using a pen-injector device.

The purpose of the study is to compare the effects of these two treatments on the growth of children with this deficiency. Participants will receive either the weekly or daily treatment over a period of time. The study will monitor how well the children grow in height and will also look at other factors like changes in bone age and certain blood markers. The study will last for several weeks, with regular visits to check on the children's progress.

Throughout the study, the safety of the treatments will be closely monitored. This includes checking for any changes in blood sugar levels and other health indicators. The study aims to provide valuable information on the effectiveness and safety of Somapacitan compared to Norditropin® in helping children with Growth Hormone Deficiency grow and develop properly.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The trial begins with an initial assessment to confirm eligibility. This includes verifying the diagnosis of growth hormone deficiency through two different tests conducted within the past year.

    Height and growth rate are measured to ensure they meet the study's criteria. The child's height must be at least 2.0 standard deviations below the average for their age and gender.

  2. Step 2

    Baseline measurements

    Baseline measurements are taken at the start of the trial. These include height, bone age, and various blood tests to assess growth factors and glucose levels.

  3. Step 3

    Treatment phase

    Participants are randomly assigned to receive either somapacitan or Norditropin®. Somapacitan is administered once weekly, while Norditropin® is given daily.

    Somapacitan is provided in pre-filled pens with dosages of 5 mg, 10 mg, or 15 mg per 1.5 mL solution, injected under the skin.

  4. Step 4

    Regular follow-up visits

    Regular follow-up visits occur throughout the trial to monitor growth and health. These visits include measurements of height, bone age, and blood tests.

    The primary endpoint is the change in height velocity from the start of the trial to week 52.

  5. Step 5

    Long-term monitoring

    Long-term monitoring continues up to week 208. This includes assessments of growth, bone age, and safety parameters such as blood glucose levels and other metabolic markers.

  6. Step 6

    Final assessment

    The trial concludes with a final assessment to evaluate the overall effects of the treatment on growth and health. This includes a comprehensive review of all collected data.

Who can join the trial?

6 criteria

  • The study is for children who have not yet started puberty. For boys, they should be at least 2 years and 26 weeks old but younger than 11 years. Their testis volume should be less than 4 milliliters. For girls, they should be at least 2 years and 26 weeks old but younger than 10 years. They should not have any breast development.
  • The child must have a confirmed diagnosis of **growth hormone deficiency**. This means they have low levels of growth hormone, which is checked by two different tests within the last year.
  • The child's height should be significantly shorter than average for their age and gender, specifically at least 2 standard deviations below the average height.
  • The child's growth rate should be slower than the 25th percentile for their age and gender. This is measured over a period of at least 6 months and up to 18 months before the study.
  • The child should have low levels of **Insulin-like Growth Factor-I (IGF-I)**, which is a protein related to growth, measured at the start of the study.
  • The child should not have received any previous treatment with growth hormone or Insulin-like Growth Factor-I (IGF-I).

Who cannot join the trial?

7 criteria

  • Children who do not have a growth hormone deficiency. This means their body produces enough growth hormone naturally.
  • Children who are not within the specific age range required for the study.
  • Children who have any other medical conditions that might interfere with the study or the treatment being tested.
  • Children who are currently taking other medications that could affect growth or interact with the study treatment.
  • Children who have had previous treatment with growth hormone or similar treatments.
  • Children who have any allergies or reactions to the study medication or its ingredients.
  • Children who are unable to follow the study procedures or attend the required visits.
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Investigated drugs

  • Somapacitan

    is a medication being studied for its effects on growth in children with growth hormone deficiency. It is administered once a week and is being compared to another growth hormone treatment to see how well it helps children grow.

  • Norditropin

    is a daily growth hormone treatment used to help children with growth hormone deficiency grow taller. In this trial, it serves as a comparison to evaluate the effectiveness and safety of the weekly dosing of somapacitan.

What is already known about the treatment

  • Somapacitan

    Somapacitan is administered as a once-weekly injection under the skin. It is currently being studied in clinical trials to evaluate its effectiveness and safety compared to daily Norditropin® for treating children with growth hormone deficiency. The main therapeutic indication is to promote growth in children who lack sufficient growth hormone. At the molecular level, somapacitan works by binding to growth hormone receptors, stimulating growth and cell reproduction. It is classified as a growth hormone analog.

  • Norditropin®

    Norditropin® is administered as a daily injection under the skin. It is an established treatment in medicine for children with growth hormone deficiency, helping them achieve normal growth. The medication works by mimicking natural growth hormone, binding to receptors, and promoting growth and development. Norditropin® is classified as a recombinant human growth hormone.

Investigated diseases

Growth Hormone Deficiency in children – This condition occurs when the pituitary gland does not produce enough growth hormone, which is essential for normal growth and development in children. As a result, affected children may experience slower growth rates and shorter stature compared to their peers. The deficiency can be present from birth or develop later in childhood. It may also lead to delayed puberty and increased fat around the waist. Over time, if untreated, it can affect bone density and muscle mass. The condition is considered rare and requires careful monitoring of growth patterns.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2023-506829-11-00Protocol codeNN8640-4263Estimated enrolment200 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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