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Somapacitan

Clinical trials are studying Somapacitan in children who need help to grow. These studies look at how well it works, how safe it is, and how it compares with daily growth hormone treatment. The target groups include children with short stature, growth hormone deficiency, small for gestational age, Turner syndrome, Noonan syndrome, and idiopathic short stature.

Table of contents

Clinical trials overview

The available studies are interventional trials, which means researchers give a treatment and then measure the results.[1] All listed trials are investigating Somapacitan in children with growth-related conditions, and the studies are either Phase 2 or Phase 3.[1][2][3][4]

Three of the studies are authorised, and one is completed.[1][2][3][4] The largest study listed has 412 participants, while the smallest has 44 participants.[1][2]

Who the trials are for

The trials focus on children who need help to grow.[1][2][3][4] The child groups include growth hormone deficiency, small for gestational age (born smaller than expected for pregnancy age), Turner syndrome, Noonan syndrome, and idiopathic short stature (short height with no clear cause).[1][2][3][4]

Some studies include several conditions in one trial, while another study focuses only on children with SGA who did not show catch-up growth by 2 years of age or older.[1][3] One study also includes children who were either new to growth hormone treatment or had already received it before.[2]

What the studies are testing

Most trials compare once-weekly Somapacitan with once-daily Norditropin®, which is the standard treatment used in these studies.[1][3][4] The goal is to see whether the weekly treatment works as well as the daily treatment for growth.[1][3][4]

One Phase 3 study, REAL 9, looks mainly at safety in children with the four listed growth conditions.[2] Safety is measured by counting adverse events, which are unwanted health problems that happen during the study.[2]

The Phase 2 study in children born SGA also compares Somapacitan with Norditropin® and checks whether the weekly treatment improves growth over 26 weeks.[3] The Phase 3 studies in children with short stature or growth hormone deficiency use a similar comparison but follow children longer, up to 52 weeks in two of the studies.[1][4]

Main outcomes measured

The main outcome in most trials is height velocity, which means how fast a child grows in height over time.[1][3][4] This outcome is usually measured in cm per year and helps show whether the treatment supports normal growth.[3][4]

In the REAL 9 study, the main outcome is the number of adverse events from week 0 to week 26.[2] In the other studies, the main focus is growth over time, with one study measuring from baseline to week 26 and two studies measuring from baseline to week 52.[1][3][4]

Trial-by-trial summary

Here is a simple view of each study and what it is trying to answer.[1][2][3][4]

  • 2023-506927-27-00: A Phase 3 study in 412 children with SGA, Turner syndrome, Noonan syndrome, or idiopathic short stature. It compares once-weekly Somapacitan with once-daily Norditropin® and checks height velocity at week 52.[1]

  • 2022-501055-87-01: A Phase 3 safety study in 44 children with the same four conditions. It looks at adverse events over 26 weeks and includes children who are new to growth hormone treatment or not new to it.[2]

  • 2023-506830-66-00: A Phase 2 study in 62 children born SGA who did not show catch-up growth. It compares Somapacitan with Norditropin® and measures height velocity from week 0 to week 26.[3]

  • 2023-506829-11-00: A completed Phase 3 study in 200 children with growth hormone deficiency. It compares Somapacitan with Norditropin® and measures height velocity from week 0 to week 52.[4]

Key points for patients

These trials are not testing Somapacitan in adults or in many other diseases; they are focused on children with growth problems.[1][2][3][4] The main question is whether a once-weekly treatment can help children grow as well as the daily treatment used as a comparison.[1][3][4]

Because the studies measure growth over time, they help researchers understand both the benefit and the safety of treatment in real patient groups.[2] The results are based on the listed study phases, participant numbers, and outcomes shown in the trial data.[1][2][3][4]

Trial ID Phase Condition studied Status Enrollment
2023-506927-27-00 Phase 3 Children with short stature: SGA, Turner syndrome, Noonan syndrome, idiopathic short stature Authorised 412
2022-501055-87-01 Phase 3 Noonan syndrome, Turner’s syndrome, idiopathic short stature, small for gestational age Authorised 44
2023-506830-66-00 Phase 2 SGA children with no catch-up growth Authorised 62
2023-506829-11-00 Phase 3 Growth hormone deficiency in children Completed 200

FAQ

  • Who can take part in Somapacitan clinical trials? The trials focus on children with growth problems. Groups include children with growth hormone deficiency, small for gestational age, Turner syndrome, Noonan syndrome, and idiopathic short stature.
  • What are the trials trying to find out? They are checking whether Somapacitan helps children grow as well as standard daily treatment. Some studies also look at safety by counting adverse events, which means unwanted medical problems during the study.
  • What phases are the Somapacitan trials? The trials listed are Phase 2 and Phase 3 studies. Phase 2 usually looks at early effectiveness, while Phase 3 compares treatments in larger groups.
  • What treatments is Somapacitan compared with? Several studies compare once-weekly Somapacitan with once-daily Norditropin®. This helps researchers see whether the weekly option works as well as the daily one.
  • What main result do these trials measure? The main result in most studies is height velocity, which means how fast a child grows in height over time. One study also measures the number of adverse events.

Ongoing Clinical Trials on Somapacitan

  • 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 the Safety and Effectiveness of Somapacitan for Children with Short Stature Due to Noonan Syndrome, Turner Syndrome, Small for Gestational Age, or Idiopathic Short Stature

    Not recruiting

    3 1 1
    Investigated drugs:
    The Netherlands Poland Spain

Glossary

  • Adverse event: Any unwanted medical problem that happens during a study, whether or not it is caused by the treatment.
  • Authorised: The study has been approved to start.
  • Baseline: The starting point before treatment begins.
  • Children born small for gestational age (SGA): Children who were smaller than expected at birth for the number of weeks of pregnancy.
  • Clinical trial: A research study in people that tests whether a treatment is safe and works.
  • Growth hormone deficiency: A condition where the body does not make enough growth hormone, which can slow growth in children.
  • Height velocity: How fast a child grows taller over a set time, usually measured in cm per year.
  • Idiopathic short stature: Short height where no clear cause is found.
  • Interventional study: A study where researchers give a treatment and then measure the results.
  • Noonan syndrome: A genetic condition that can affect growth and other parts of health.
  • Phase 2: A study phase that looks more closely at whether a treatment may work and how it performs in a smaller group.
  • Phase 3: A later study phase that compares treatments in larger groups to confirm benefits and safety.
  • Turner syndrome: A genetic condition in girls that can cause short stature and other health issues.

References

  1. https://clinicaltrials.gov/study/2023-506927-27-00
  2. https://clinicaltrials.gov/study/2022-501055-87-01
  3. https://clinicaltrials.gov/study/2023-506830-66-00
  4. https://clinicaltrials.gov/study/2023-506829-11-00