Assessment of Body Composition in Children Treated With Growth Hormone for the Indication of Isolated Non-acquired Growth Hormone Deficiency.

Recruiting now

Conditions studied: Isolated Non-acquired Growth Hormone Deficiency

In brief

Since 1985, growth hormone deficiency (GHD) in children has been the first condition treated with daily injections of recombinant human growth hormone. Noncompliance with daily growth hormone (GH) therapy is common. Several long-acting growth hormone (LAGH) treatments have recently become available for prescription in France after pivotal phase III trials demonstrated the non-inferiority of these LAGH compared to daily GH administration. To date, published data on LAGH in children are largely limited to clinical trials of GH deficiency (GHD). Contrary to what is observed with daily GH, body mass index increases during the first year of LAGH treatment. With the Somapacitan, the observed mean body mass index (BMI) (SDS) remained within the normal range, but with an increase from -0.17 to +0.39 in the LAGH group and a decrease from -0.25 to -0.49 in the daily GH group. In the Somatrogon study, BMI increased from -0.51 to -0.08 in the somatrogon group, while it decreased from -0.44 to -0.64 in the daily GH group. This increase in BMI was transient and then normalized over the 3-year follow-up. In June 2025, recent data from the experience of private endocrinologists in France (AFPEL) on the real-life use of somatrogon were presented at the congress of the French Society of Pediatric Endocrinology and Diabetology. They reported a +1 SD increase in BMI during the first months of treatment in a cohort of 99 children, but an improvement was observed after prolonged treatment. However, significant and persistent weight gain was observed in some patients, with a marked increase in abdominal adiposity. Some discontinued LAGH treatment in favor of daily GH. Longer-term, real-life data are therefore needed to better understand the changes in BMI in these children treated with LAGH.

Key facts

Study ID

NCT07333521

Run by

Assistance Publique - Hôpitaux de Paris

People needed

200

Starts

2026-01-13

Expected to finish

2034-01-13

Last updated by the study team

2026-06-24

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged 3 to 17 years inclusive.
• Confirmed diagnosis of growth hormone deficiency.
• Indication for treatment with daily or depot growth hormone.
• Growth hormone treatment naive or already being treated with growth hormone and wishing to change galenical.
• Holders of parental authority and children or adolescents informed and consenting to participate in the study.

You may not qualify if…

• BMI greater than +3 SD.
• Multiple pituitary insufficiency.
• Acquired growth hormone insufficiency.
• Patient with type 1 or type 2 diabetes.
• Known eating disorders.

Where it is running

• Hôpital Necker-Enfants Malades — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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