Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study Comparing Somapacitan and Somatropin for Growth in Children with Short Stature Due to Small for Gestational Age, Turner Syndrome, Noonan Syndrome, or Idiopathic Short Stature

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on children with short stature, which means they are shorter than most children their age. The study includes children who were either born small for their age, or have conditions like Turner syndrome, Noonan syndrome, or idiopathic short stature, which means the cause of their short stature is unknown. The trial is testing a new treatment called somapacitan, which is given once a week, and comparing it to a daily treatment called Norditropin®. Both treatments are designed to help children grow taller.

The purpose of the study is to see if the once-weekly somapacitan is as effective as the daily Norditropin® in helping children grow. The study will last for a period of time, during which children will receive either somapacitan or Norditropin®. The somapacitan is administered using a special pen-injector called the PDS290 pen-injector, which is a pre-filled device that makes it easier to give the injection. The study will monitor the children's growth over time, specifically looking at how fast they grow in height.

Throughout the study, researchers will also keep an eye on the long-term safety of somapacitan. They will measure various health indicators, such as changes in bone age and levels of certain substances in the blood, like IGF-I and IGFBP-3, which are related to growth. The study aims to provide valuable information on whether somapacitan can be a safe and effective option for children with short stature conditions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be assessed to ensure they meet the criteria for inclusion. This includes being a child with short stature due to being born small for gestational age, Turner syndrome, Noonan syndrome, or idiopathic short stature.

    The participant must not have had any prior exposure to growth-promoting therapies.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to establish baseline measurements. This includes measuring height, weight, and other relevant health indicators.

    The participant's bone age will also be assessed to ensure it aligns with the study's requirements.

  3. Step 3

    Medication administration

    The participant will receive either somapacitan or Norditropin as part of the study.

    Somapacitan is administered once weekly via a subcutaneous injection using a pre-filled pen. The available dosages are 5 mg, 10 mg, or 15 mg per 1.5 mL solution.

    Norditropin is administered daily via a subcutaneous injection using a pre-filled pen.

  4. Step 4

    Ongoing monitoring

    Throughout the study, the participant's growth will be monitored regularly. This includes measuring height velocity, which is the rate of growth over time.

    Additional health indicators such as changes in bone age, fasting plasma glucose, and glycated hemoglobin levels will also be monitored.

  5. Step 5

    End of study assessment

    At the end of the study period, a final assessment will be conducted to evaluate the participant's growth and overall health.

    The primary goal is to confirm that once-weekly somapacitan is not inferior to daily Norditropin in promoting growth.

Who can join the trial?

14 criteria

  • The child must not have had any previous treatment to help them grow, such as growth hormone or other similar treatments.
  • If the child was born small for their age (SGA), they must have been born with a length or weight below a certain level according to national standards.
  • For boys born small for their age (SGA), they must be at least 2 years and 26 weeks old but younger than 11 years at the start of the study, and their testis volume must be below 4 mL.
  • For girls born small for their age (SGA), they must be at least 2 years and 26 weeks old but younger than 10 years at the start of the study, and they must not have started breast development.
  • For girls with Turner syndrome (TS), they must have a confirmed diagnosis of TS.
  • For girls with Turner syndrome (TS), they must be at least 2 years and 26 weeks old but younger than 10 years at the start of the study, and they must not have started breast development.
  • For children with Noonan syndrome (NS), they must have a clinical diagnosis according to a specific score list.
  • For boys with Noonan syndrome (NS), they must be at least 2 years and 26 weeks old but younger than 11 years at the start of the study, and their testis volume must be below 4 mL.
  • For girls with Noonan syndrome (NS), they must be at least 2 years and 26 weeks old but younger than 10 years at the start of the study, and they must not have started breast development.
  • For children with idiopathic short stature (ISS), they must be prepubertal, meaning they have not started puberty.
  • For boys with idiopathic short stature (ISS), they must be at least 2 years and 26 weeks old but younger than 11 years at the start of the study, and their testis volume must be below 4 mL.
  • For girls with idiopathic short stature (ISS), they must be at least 2 years and 26 weeks old but younger than 10 years at the start of the study, and they must not have started breast development.
  • For boys with idiopathic short stature (ISS), their bone age must be 12 years or younger, and it should not be more than 2 years different from their actual age.
  • For girls with idiopathic short stature (ISS), their bone age must be 11 years or younger, and it should not be more than 2 years different from their actual age.

Who cannot join the trial?

7 criteria

  • Children who are not diagnosed with short stature conditions like being born small for gestational age, Turner syndrome, Noonan syndrome, or idiopathic short stature cannot participate.
  • Children who are not within the specified age range for the study cannot participate.
  • Children who have any other medical conditions that might interfere with the study cannot participate.
  • Children who are taking medications that could affect growth cannot participate.
  • Children who have had previous treatment with growth hormone therapy cannot participate.
  • Children who have any allergies or reactions to the study medication cannot participate.
  • Children who are unable to comply with the study procedures cannot participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Somapacitan

    is a medication used in this study to help children grow taller. It is given once a week and is being tested to see if it works as well as another medication that is given every day. The study is looking at how well it helps children who are shorter than usual because they were born small, have Turner syndrome, Noonan syndrome, or have no known reason for their short stature.

  • Norditropin

    is a medication that is already used to help children grow taller. It is given every day and is being compared to somapacitan in this study. The goal is to see if the once-a-week medication works just as well as this daily treatment in helping children grow.

What is already known about the treatment

  • Somapacitan

    This medication is administered as an injection under the skin, typically once a week. It is currently being studied in clinical trials to assess its effectiveness and safety for children with short stature due to conditions like being born small for gestational age, Turner syndrome, Noonan syndrome, or idiopathic short stature. Somapacitan works by mimicking the action of natural growth hormone, stimulating growth and cell reproduction. It is classified as a growth hormone therapy.

  • Norditropin

    This medication is administered as a daily injection under the skin. It is an established treatment used to promote growth in children with short stature due to various conditions, including being born small for gestational age, Turner syndrome, Noonan syndrome, or idiopathic short stature. Norditropin functions by replacing or supplementing natural growth hormone, encouraging growth and development. It belongs to the pharmacological class of growth hormone therapies.

Investigated diseases

  • Short Stature in Children Born Small for Gestational Age (SGA)

    This condition occurs when a child is born smaller than the typical size for the number of weeks of pregnancy. These children may experience slower growth rates compared to their peers. Over time, they might not catch up in height, leading to a diagnosis of short stature. The growth pattern can vary, with some children showing improvement in growth velocity during early childhood.

  • Turner Syndrome

    A genetic disorder affecting females, characterized by the partial or complete absence of one of the X chromosomes. This condition often results in short stature, which becomes noticeable by early childhood. Other features may include delayed puberty and certain physical characteristics. Growth hormone therapy is commonly used to help increase height in affected individuals.

  • Noonan Syndrome

    A genetic disorder that can affect various parts of the body, often leading to distinctive facial features, heart defects, and short stature. Children with Noonan syndrome may have a slower growth rate, which becomes apparent in early childhood. The condition can also be associated with developmental delays and other health issues. Growth patterns can vary widely among individuals with this syndrome.

  • Idiopathic Short Stature (ISS)

    This term is used when a child is significantly shorter than average for their age and sex, with no identifiable medical cause. Children with ISS have normal body proportions and no signs of systemic disease. The growth rate is typically slower than average, and the final adult height is often below the expected range. The condition is diagnosed after ruling out other potential causes of short stature.

Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2023-506927-27-00Protocol codeNN8640-4467Estimated enrolment412 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.