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Somatropin

Clinical trials investigating Somatropin are studying growth-related conditions in children and some related hormone and metabolism questions in adults. These studies look at how well treatment works, how safe it is, and how it compares with other growth hormone treatments in different patient groups.

Table of Contents

Trial overview

The trial data show several studies that investigate Somatropin-related growth treatment in children and, in one study, hormone and metabolism questions in adults.[1][2][3][4][5][6][7] Most of the studies are interventional trials, which means researchers give a treatment and then measure the results.[1][2][3][4][5][6][7]

Who is being studied

Several trials focus on children with growth hormone deficiency, which means the body does not make enough growth hormone for normal growth.[1][5] Other studies include children who were small for gestational age (SGA), children with Turner syndrome, Noonan syndrome, idiopathic short stature, or SHOX-D.[2][3][7] One trial is in boys with short predicted height, meaning the study expects their adult height may be lower than average.[4]

One Phase 2 study includes people with acromegaly and healthy volunteers, and it looks at metabolism in humans.[6] This makes the trial set broader than growth studies alone, but the main focus across the data is still growth-related research.[1][2][3][4][5][7]

Trial designs and phases

The listed studies are mainly in Phase 3, with two studies in Phase 2.[1][2][3][4][5][6][7] Phase 2 studies usually look at early effects in a smaller group, while Phase 3 studies test treatment effects in larger groups and often compare different options.[3][6] Enrollment ranges from 30 people to 412 people, showing that some studies are small and focused while others are larger comparison trials.[2][6]

Several studies compare weekly treatment with daily treatment, especially weekly somapacitan-based regimens versus daily Norditropin®.[1][2][3] One Phase 3 study compares daily Somatropin with weekly lonapegsomatropin in children and adolescents.[7]

What the trials measure

The most common primary outcome is height velocity, which means how fast a child grows over time, usually measured in centimeters per year.[1][2][3][7] One study measures height velocity from baseline to week 52, while another measures it from baseline to week 26.[1][3] The Phase 3 GHD Reversal Trial measures Final Height in Standard Deviation Score (FH SDS), which compares final height with the average height expected for age and sex.[5]

The OMNIMARA Trial measures adult height gain, defined as final height minus predicted adult height.[4] The metabolism study measures GH-induced changes in energy-rich phosphate metabolism, including ATP turnover, which is a way to look at how the body uses energy.[6] These outcomes show that the trials are not only checking whether treatment helps children grow, but also whether it changes longer-term height and body metabolism.[1][4][6]

Key treatment comparisons

Several trials compare Somatropin-related weekly treatment with daily Norditropin®.[1][2][3] In the growth hormone deficiency study, children receive somapacitan once a week or Norditropin® once a day.[1] In the SGA study, children born small and who stayed small are also treated with weekly somapacitan or daily Norditropin®.[3]

The study in children with short stature linked to SGA, Turner syndrome, Noonan syndrome, or idiopathic short stature aims to confirm that weekly somapacitan is non-inferior, meaning it is not worse than daily Norditropin® by more than a set amount.[2] The Phase 3 trial in children with short predicted height tests whether combining GH treatment with letrozole during puberty gives more adult height gain than GH alone.[4] Another Phase 3 study compares weekly lonapegsomatropin with daily Somatropin in children and adolescents with growth failure due to growth hormone sufficient disorders.[7]

What these studies may mean for patients

For patients and families, these trials mainly ask whether different growth treatments can help children grow better, with fewer injections or different treatment schedules.[1][2][3][7] The studies also try to understand whether treatment can improve final adult height, not only short-term growth.[4][5] Because the trials include different growth conditions, they help researchers learn which children may benefit most from each treatment approach.[1][2][3][4][5][7]

Trial ID Phase Condition studied Status Enrollment
2023-506829-11-00 Phase 3 Growth Hormone Deficiency in children Completed 200
2023-506927-27-00 Phase 3 Short stature in children with SGA, Turner syndrome, Noonan syndrome, or idiopathic short stature Authorised 412
2023-506830-66-00 Phase 2 SGA – small for gestational age children Authorised 62
2024-519935-41-00 Phase 3 Short predicted height Authorised 50
2022-502008-62-00 Phase 3 Growth Hormone Deficiency (GHD) Completed 40
2024-518214-11-01 Phase 2 Acromegaly, healthy Authorised 30
2025-523079-44-00 Phase 3 Turner Syndrome, idiopathic short stature, SHOX-D, small for gestational age Authorised 186

FAQ

  • Who is being studied in Somatropin clinical trials? Most trials focus on children with growth problems, such as growth hormone deficiency, being born small for gestational age, Turner syndrome, Noonan syndrome, or idiopathic short stature. One trial also includes adults with acromegaly and healthy people for metabolism research.
  • What are these trials trying to find out? The main goal is to see how well treatment improves growth, often measured by height velocity, which means how fast a child grows in one year. Some studies also compare final height outcomes or study changes in metabolism.
  • What phases are the Somatropin trials in? The listed studies are mainly Phase 2 and Phase 3 trials. Phase 2 studies usually explore effects in a smaller group, while Phase 3 studies compare treatments in larger groups and help confirm results.
  • Are Somatropin trials comparing different treatments? Yes. Several trials compare weekly treatment options with daily Norditropin®, and one trial compares daily Somatropin with weekly lonapegsomatropin. Another study looks at Somatropin together with letrozole in boys with low predicted adult height.
  • What outcomes are measured in these trials? The most common outcome is height velocity, measured over weeks or months. Other outcomes include adult height gain, final height in standard deviation score, and changes in metabolism.

Ongoing Clinical Trials on Somatropin

  • Study of Lonapegsomatrin and Somatropin in Children and Adolescents with Short Stature or Growth Failure due to Turner Syndrome, SHOX Deficiency, SGA, or Idiopathic Short Stature

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Romania Spain

  • Study on the Effects of Pegvisomant and Somatropin on Liver Fat Metabolism in Patients with Acromegaly and Healthy Individuals

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria

  • Study on the Effects of Somatropin and Letrozole in Boys with Short Predicted Height

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

  • Study on the Effects of Somapacitan and Somatropin in Children with Short Stature Born Small for Gestational Age Without Catch-Up Growth by Age 2

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria France Hungary Italy Latvia

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

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria France Germany Italy Latvia Poland +2

  • 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

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Bulgaria Croatia Finland France +10

  • Study on Growth Hormone Deficiency: Comparing Effects of Continuing vs. Stopping Somatropin Treatment in Pubertal Children with Isolated Growth Hormone Deficiency

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria

Glossary

  • Growth hormone deficiency: A condition where the body does not make enough growth hormone, which can lead to slower growth in children.
  • Short stature: A height that is lower than expected for a child’s age and sex.
  • Small for gestational age (SGA): A baby who is smaller than expected at birth for the number of weeks of pregnancy.
  • Turner syndrome (TS): A genetic condition that can affect growth and development in girls.
  • Noonan syndrome (NS): A genetic condition that can cause short height and other health problems.
  • Idiopathic short stature (ISS): Short height without a clear medical cause.
  • Height velocity: How fast a child grows over a set time, usually measured in centimeters per year.
  • Standard deviation score (SDS): A way to compare a child’s height with the average height for age and sex.
  • Final height: The height a person reaches when growth is mostly complete.
  • Non-inferiority: A study goal showing that one treatment is not worse than another by more than a set amount.
  • Interventional study: A trial where researchers give a treatment and then measure the results.

References

  1. https://clinicaltrials.gov/study/2023-506829-11-00
  2. https://clinicaltrials.gov/study/2023-506927-27-00
  3. https://clinicaltrials.gov/study/2023-506830-66-00
  4. https://clinicaltrials.gov/study/2024-519935-41-00
  5. https://clinicaltrials.gov/study/2022-502008-62-00
  6. https://clinicaltrials.gov/study/2024-518214-11-01
  7. https://clinicaltrials.gov/study/2025-523079-44-00