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

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What is this study about?

This clinical trial is focused on studying children with a condition known as Growth Hormone Deficiency. This condition occurs when the body does not produce enough growth hormone, which is important for growth and development. The study is comparing two treatments: Somapacitan, which is given once a week, and Norditropin®, which is administered daily. Both treatments are solutions for injection, delivered using a pen-injector device.

The purpose of the study is to compare the effects of these two treatments on the growth of children with this deficiency. Participants will receive either the weekly or daily treatment over a period of time. The study will monitor how well the children grow in height and will also look at other factors like changes in bone age and certain blood markers. The study will last for several weeks, with regular visits to check on the children’s progress.

Throughout the study, the safety of the treatments will be closely monitored. This includes checking for any changes in blood sugar levels and other health indicators. The study aims to provide valuable information on the effectiveness and safety of Somapacitan compared to Norditropin® in helping children with Growth Hormone Deficiency grow and develop properly.

1 initial assessment

The trial begins with an initial assessment to confirm eligibility. This includes verifying the diagnosis of growth hormone deficiency through two different tests conducted within the past year.

Height and growth rate are measured to ensure they meet the study’s criteria. The child’s height must be at least 2.0 standard deviations below the average for their age and gender.

2 baseline measurements

Baseline measurements are taken at the start of the trial. These include height, bone age, and various blood tests to assess growth factors and glucose levels.

3 treatment phase

Participants are randomly assigned to receive either somapacitan or Norditropin®. Somapacitan is administered once weekly, while Norditropin® is given daily.

Somapacitan is provided in pre-filled pens with dosages of 5 mg, 10 mg, or 15 mg per 1.5 mL solution, injected under the skin.

4 regular follow-up visits

Regular follow-up visits occur throughout the trial to monitor growth and health. These visits include measurements of height, bone age, and blood tests.

The primary endpoint is the change in height velocity from the start of the trial to week 52.

5 long-term monitoring

Long-term monitoring continues up to week 208. This includes assessments of growth, bone age, and safety parameters such as blood glucose levels and other metabolic markers.

6 final assessment

The trial concludes with a final assessment to evaluate the overall effects of the treatment on growth and health. This includes a comprehensive review of all collected data.

Who Can Join the Study?

The study is for children who have not yet started puberty. For boys, they should be at least 2 years and 26 weeks old but younger than 11 years. Their testis volume should be less than 4 milliliters. For girls, they should be at least 2 years and 26 weeks old but younger than 10 years. They should not have any breast development.
The child must have a confirmed diagnosis of growth hormone deficiency. This means they have low levels of growth hormone, which is checked by two different tests within the last year.
The child’s height should be significantly shorter than average for their age and gender, specifically at least 2 standard deviations below the average height.
The child’s growth rate should be slower than the 25th percentile for their age and gender. This is measured over a period of at least 6 months and up to 18 months before the study.
The child should have low levels of Insulin-like Growth Factor-I (IGF-I), which is a protein related to growth, measured at the start of the study.
The child should not have received any previous treatment with growth hormone or Insulin-like Growth Factor-I (IGF-I).

Who Cannot Join the Study?

Children who do not have a growth hormone deficiency. This means their body produces enough growth hormone naturally.
Children who are not within the specific age range required for the study.
Children who have any other medical conditions that might interfere with the study or the treatment being tested.
Children who are currently taking other medications that could affect growth or interact with the study treatment.
Children who have had previous treatment with growth hormone or similar treatments.
Children who have any allergies or reactions to the study medication or its ingredients.
Children who are unable to follow the study procedures or attend the required visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Pomeranian Medical University	Szczecin	Poland

Other Sites

Site Name	City	Country
Noe LGA Gesundheit Region Mitte GmbH	St. Poelten	Austria
Azienda Ospedaliera Universitaria Meyer IRCCS	Florence	Italy
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Instytut Pomnik Centrum Zdrowia Dziecka	Warsaw	Poland
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Hopital Beaujon	Clichy	France
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Endokrinologikum Frankfurt	Frankfurt	Germany
Blwfx Ksbihljs Uomlqocbputjr Sxrgjedx Vpjh	Riga	Latvia
Ugmznxkjvp Cppmhagkkwytxqvw Hbqtucja	Ljubljana	Slovenia
Cgunbv Hkbbdmlehzi Rwiscpxl Dovdvdahncgiwb	Angers	France

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	18.06.2019
France	Not recruiting	18.06.2019
Germany	Not recruiting	18.06.2019
Italy	Not recruiting	18.06.2019
Latvia	Not recruiting	18.06.2019
Poland	Not recruiting	18.06.2019
Slovenia	Not recruiting	18.06.2019
Spain	Not recruiting	18.06.2019

Trial locations

Investigated drugs:

Somapacitan is a medication being studied for its effects on growth in children with growth hormone deficiency. It is administered once a week and is being compared to another growth hormone treatment to see how well it helps children grow.

Norditropin is a daily growth hormone treatment used to help children with growth hormone deficiency grow taller. In this trial, it serves as a comparison to evaluate the effectiveness and safety of the weekly dosing of somapacitan.

Investigated diseases:

Growth hormone deficiency

Growth Hormone Deficiency in children – This condition occurs when the pituitary gland does not produce enough growth hormone, which is essential for normal growth and development in children. As a result, affected children may experience slower growth rates and shorter stature compared to their peers. The deficiency can be present from birth or develop later in childhood. It may also lead to delayed puberty and increased fat around the waist. Over time, if untreated, it can affect bone density and muscle mass. The condition is considered rare and requires careful monitoring of growth patterns.

Trial ID:

2023-506829-11-00

Protocol code:

NN8640-4263

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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