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

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What is this study about?

This clinical trial is focused on children who were born small for gestational age (SGA) and have not experienced catch-up growth by the age of two or older. The study is evaluating the effects and safety of a new treatment called somapacitan, which is given once a week, compared to a daily treatment with Norditropin®. Both treatments are designed to help improve growth in children with short stature due to being born SGA.

The purpose of the study is to assess how well somapacitan works in promoting growth compared to Norditropin®. Participants in the study will receive either somapacitan or Norditropin® through a pen-injector, which is a device used to inject the medication under the skin. The study will last for a period of time during which the growth of the children will be monitored and compared between the two treatment groups.

Throughout the study, researchers will observe changes in the children’s height and other growth-related factors. The study aims to provide valuable information on the effectiveness and safety of somapacitan as a treatment option for children with growth challenges due to being born SGA. This research could potentially lead to new treatment options for children who need help with their growth development.

1 initial assessment

The trial begins with an initial assessment to confirm eligibility. This includes measuring height and weight to ensure they meet the criteria for being small for gestational age (SGA).

The assessment also checks that the child has not experienced catch-up growth by the age of 2 years or older.

2 baseline measurements

Baseline measurements are taken to establish starting points for height and other health indicators.

These measurements will be used to track changes throughout the trial.

3 treatment allocation

Participants are randomly assigned to one of two treatment groups: one receiving somapacitan once a week, and the other receiving Norditropin daily.

Somapacitan is administered as a subcutaneous injection using a pre-filled pen, available in doses of 5 mg, 10 mg, or 15 mg per 1.5 mL.

Norditropin is also administered as a subcutaneous injection using a pre-filled pen.

4 weekly or daily treatment

Participants in the somapacitan group receive their injection once a week.

Participants in the Norditropin group receive their injection daily.

The treatment continues for a period of 52 weeks.

5 regular follow-up visits

Regular follow-up visits are scheduled to monitor progress and assess any changes in height and other health indicators.

These visits occur at specific intervals, including week 26 and week 52.

6 final assessment

At the end of the trial, a final assessment is conducted to evaluate the overall effect of the treatment on growth and other health parameters.

The primary focus is on changes in height velocity, which is the rate of growth in centimeters per year.

Who Can Join the Study?

The child must be a prepubertal child, which means they have not yet started puberty.
For boys, they must be at least 2 years and 26 weeks old but younger than 11 years at the time of screening. Their testis volume should be less than 4 milliliters.
For girls, they must be at least 2 years and 26 weeks old but younger than 10 years at the time of screening. They should be at Tanner stage 1 for breast development, meaning there is no noticeable breast tissue.
The child must have been born small for gestational age, which means their birth length and/or weight was less than 2 standard deviations below the average for their age at birth, according to national standards.
The child must have impaired height, meaning their height is at least 2.5 standard deviations below the average height for their age and gender, based on the standards of the Centers for Disease Control and Prevention.
The child must have impaired height velocity, which means their growth rate is below the 50th percentile for their age and gender, calculated over a period of at least 6 months and up to 18 months before screening.
The child must not have had any previous treatment with growth hormone therapy or Insulin-like Growth Factor-I (IGF-I) treatment.

Who Cannot Join the Study?

Children who are not considered small for gestational age (SGA). This means they were not smaller than usual when they were born.
Children who have experienced catch-up growth by the age of 2 or older. Catch-up growth is when a child grows faster than usual to reach the normal size for their age.
Children who are not between the ages of 2 and older.
Children who are not experiencing short stature. Short stature means being shorter than most children of the same age and gender.
Children who are not eligible for the study due to other health conditions or factors not specified here.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Azienda Ospedaliera Universitaria Meyer IRCCS	Florence	Italy
Kepler Universitaetsklinikum GmbH	Linz	Austria
Hopital Beaujon	Clichy	France
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
University Of Szeged	Szeged	Hungary
Budug Kdjeokna Ulzvoqutmesmp Stlwmyez Vane	Riga	Latvia

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	08.07.2019
France	Not recruiting	08.07.2019
Hungary	Not recruiting	08.07.2019
Italy	Not recruiting	08.07.2019
Latvia	Not recruiting	08.07.2019

Trial locations

Investigated drugs:

Somapacitan is a medication being tested for its ability to help children grow taller. It is given once a week and is being studied to see if it can help children who were born smaller than usual and have not grown as expected by the age of two.

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 to see which one is more effective in helping children who were born smaller than usual and have not caught up in growth by the age of two.

Investigated diseases:

Short stature

Small for Gestational Age (SGA) Children – This condition refers to children who are smaller in size than the typical range for their gestational age at birth. It is often identified when a newborn’s weight is below the 10th percentile for their gestational age. These children may not experience the expected “catch-up” growth by the age of two or older, leading to short stature. The growth delay can be due to various factors, including genetic influences or environmental conditions during pregnancy. Over time, these children may continue to grow at a slower rate compared to their peers. Monitoring growth patterns is essential to understand the progression and impact on overall development.

Trial ID:

2023-506830-66-00

Protocol code:

NN8640-4245

Trial Phase:

Therapeutic exploratory (Phase II)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?