In short
There are currently 2 ongoing clinical trials investigating treatments for children born small for gestational age who have not experienced adequate catch-up growth. These studies are testing new approaches to help promote growth in affected children, with trials taking place across several European countries.
Clinical trial locations
- Austria
- France
- Hungary
- Italy
- Latvia
- Netherlands
- Poland
- Spain
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
This trial is evaluating a new weekly treatment called somapacitan compared to the established daily treatment Norditropin in children who were born smaller than usual and have not caught up in growth by age two or older.
Who can participate:
- Children who have not yet started puberty
- Boys aged 2 years and 26 weeks to under 11 years, with testis volume less than 4 milliliters
- Girls aged 2 years and 26 weeks to under 10 years, at Tanner stage 1 for breast development
- Children born with birth length and/or weight at least 2 standard deviations below average
- Children whose current height is at least 2.5 standard deviations below average for their age and gender
- Children with slower than normal growth rate over at least 6 months
- Children who have never received growth hormone therapy or IGF-I treatment before
Who cannot participate:
- Children who were not small at birth
- Children who have already experienced catch-up growth by age 2 or older
- Children outside the specified age range
- Children without short stature
- Children with other health conditions that make them unsuitable for the study
What the trial involves: The study compares two growth-promoting treatments. Participants will be randomly assigned to receive either somapacitan once weekly or Norditropin daily, both given as injections under the skin using a pen-injector device. The trial lasts 52 weeks, with regular follow-up visits at weeks 26 and 52 to monitor growth progress. Researchers will measure height changes and assess the safety of both treatments.
Investigational drugs: Somapacitan is a new medication given once a week that mimics natural growth hormone to help children grow taller. It is being compared to Norditropin, an established daily growth hormone treatment already used to help children with growth challenges.
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
This trial is studying the safety and effectiveness of somapacitan in children with short stature due to various conditions, including being born small for gestational age, as well as Turner syndrome, Noonan syndrome, or idiopathic short stature (short height without a known cause).
Who can participate:
- Children born smaller than usual for their weeks of pregnancy, according to national standards
- Female children with Turner syndrome within a specific age range
- Male and female children with Noonan syndrome within a specific age range
- Male and female children with idiopathic short stature within a specific age range
- All participants must have open growth plates in their bones, allowing for continued growth
- Diagnoses must be confirmed according to local clinical practice
Who cannot participate:
- Children with other significant medical conditions that could interfere with the study
- Children who have received growth hormone treatment within the last 6 months
- Children with known allergies to the study medication or its ingredients
- Children currently participating in another clinical trial
- Children with a history of cancer or serious illness
- Children unable to follow study procedures
- Children deemed unsuitable by the investigator
What the trial involves: Participants receive somapacitan as a once-weekly injection under the skin at a dose of 15 mg. The study includes an initial visit with physical examination and eligibility assessment, followed by weekly follow-ups to monitor growth and check for side effects. A comprehensive evaluation occurs at 26 weeks, and the study continues with regular monitoring until 156 weeks (about 3 years). Throughout the trial, researchers track growth progress and record any unexpected medical problems.
Investigational drug: Somapacitan is a growth hormone therapy given once weekly that mimics the natural growth hormone in the body. It aims to stimulate growth in children who have a deficiency or need additional support to achieve normal height.
Summary
Both ongoing trials are investigating somapacitan, a once-weekly growth hormone treatment, as a potential alternative to current daily therapies for children born small for gestational age who have not experienced adequate catch-up growth. The trials are concentrated in European countries, with the first study taking place in Austria, France, Hungary, Italy, and Latvia, while the second study is being conducted in the Netherlands, Poland, and Spain.
The first trial specifically focuses on comparing somapacitan to Norditropin in children with growth challenges due to being born small for gestational age. The second trial has a broader scope, including children born small for gestational age alongside those with other growth conditions. Both studies emphasize the importance of regular monitoring and safety assessment throughout the treatment period.
These trials represent efforts to develop more convenient treatment options for families, as weekly injections may be easier to manage than daily treatments. However, the studies are still ongoing, and their results will help determine whether somapacitan is safe and effective for these young patients.
