Isolated Non-acquired Growth Hormone DeficiencyCOMPOGHDNCT07333521
Assessment of Body Composition in Children Treated With Growth Hormone for the Indication of Isolated Non-acquired Growth Hormone Deficiency.
An observational study of Isolated Non-acquired Growth Hormone Deficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Isolated Non-acquired Growth Hormone Deficiency
- What is being tested?
- Auxological measurements and impedancemetry
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2026to 13 Jan 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: All children in the Department of Pediatric Endocrinology, Gynecology and Diabetology at Necker Enfants Malades University Hospital treated with growth hormone, with the daily form or the delayed form, for the indication of isolated non-acquired growth hormone deficiency, naive to growth hormone treatment or already being treated with growth hormone and wishing to change galenical.
Who may be able to join
- 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.
Who cannot join
- BMI greater than +3 SD.
- Multiple pituitary insufficiency.
- Acquired growth hormone insufficiency.
- Patient with type 1 or type 2 diabetes.
- Known eating disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Necker-Enfants Malades
Paris, 75015
Michel MD, PhD POLAK, MD, PhD, 01 44 49 48 02 ext. +33, michel.polak@aphp.fr
Dulanjalee MD KARIYAWASAM, MD
About this study
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.
Read more
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.
Read the detailed description
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.
The study concerns all children in the Department of Pediatric Endocrinology, Gynecology and Diabetology at Necker Enfants Malades University Hospital treated with growth hormone, with the daily form or the delayed form, for the indication of isolated non-acquired growth hormone deficiency, naive to growth hormone treatment or already being treated with growth hormone and wishing to change galenical. Auxological measurements and with the Zmetric impedance meter will be carried out at each visit of the child's usual follow-up, from the day of the start of growth hormone treatment, for 3 years.
- Being tested
- Auxological measurements and impedancemetry
- Keywords
- Isolated non-acquired growth hormone deficiency, Daily growth hormone therapy, Long-acting growth hormone treatments, Body mass index, Auxological measurements, Impedancemetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auxological measurements and impedancemetryOther
Auxological measurements and with the Zmetric impedance meter will be carried out at each visit of the child's usual follow-up, from the day of the start of growth hormone treatment, for 3 years.
Auxological measurements and impedancemetryOther
Auxological measurements and with the Zmetric impedance meter will be carried out at each visit of the child's usual follow-up, from the day of the change of the galenical of the growth hormone treatment, for 3 years.
| Study group | Role | What they receive |
|---|---|---|
| Patients with isolated non-acquired growth hormone deficiency naive to growth hormone treatment | All children in the Department of Pediatric Endocrinology, Gynecology and Diabetology at Necker Enfants Malades University Hospital treated with growth hormone, with the daily form or the delayed form, for the indication of isolated non-acquired growth hormone deficiency, naive to growth hormone treatment. Receives: Other: Auxological measurements and impedancemetry | |
| Patients with isolated non-acquired growth hormone deficiency treated with growth hormone | All children in the Department of Pediatric Endocrinology, Gynecology and Diabetology at Necker Enfants Malades University Hospital treated with growth hormone, with the daily form or the delayed form, for the indication of isolated non-acquired growth hormone deficiency, already being treated with growth hormone and wishing to change galenical. Receives: Other: Auxological measurements and impedancemetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
Body mass index calculation at each visit of the child's usual follow-up, from the day of the start of growth hormone treatment or the change of the galenical and during 3 years.
Measured: At the start of treatment or new galenical, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months
Secondary outcomes (6)
Amount of muscle mass
Description of the body composition of children treated with GH for the indication of isolated growth hormone deficiency before the start of treatment or the change of the galenical and during 3 years.
Amount of muscle mass in kg, in %, in kg/m2.
Measured: At the start of treatment or new galenical, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months
Amount of fat mass
Description of the body composition of children treated with GH for the indication of isolated growth hormone deficiency before the start of treatment or the change of the galenical and during 3 years.
Amount of fat mass in kg, in %, in kg/m2.
Measured: At the start of treatment or new galenical, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months
Bone mineral content
Description of the body composition of children treated with GH for the indication of isolated growth hormone deficiency before the start of treatment or the change of the galenical and during 3 years.
Bone mineral content in %.
Measured: At the start of treatment or new galenical, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months
Amount of extracellular and intracellular water
Description of the body composition of children treated with GH for the indication of isolated growth hormone deficiency before the start of treatment or the change of the galenical and during 3 years.
Amount of extracellular and intracellular water (in L).
Measured: At the start of treatment or new galenical, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months
Hydration of fat-free mass
Description of the body composition of children treated with GH for the indication of isolated growth hormone deficiency before the start of treatment or the change of the galenical and during 3 years.
Hydration of fat-free mass (in %).
Measured: At the start of treatment or new galenical, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months
Description of the efficacy and tolerance of growth hormone treatment
Description and evolution of health parameters from the patient's usual care during 3 years :
- Weight, height, waist circumference if over 6 years old, growth rate. Tanner stage.
- Blood pressure.
- Clinical examination: abnormalities at injection sites, stretch marks, thyroid palpation.
- Questionnaire on treatment tolerance: possible adverse events.
- IGF-1 levels in ng/ml.
- IGF-BP3 levels if available (not routinely measured).
- Fasting blood glucose, HbA1c.
- TSH, FT4 if available.
- Gonadotropin, testosterone/estradiol levels if available.
- Lipid profile : investigation of lipid abnormalities, if available.
- Liver function tests: AST, ALT, Gamma-GT, bilirubin.
Measured: At the start of treatment or new galenical, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start13 Jan 2026
- Primary completion13 Jan 2034 (estimated)
- Study completion13 Jan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Isolated Non-acquired Growth Hormone DeficiencyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Michel MD, PhD POLAK, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisDinane MD SAMARA-BOUSTANI, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333521
- Sponsor's protocol ID
- APHP251216
- Other IDs
- 2025-A01871-48
- Acronym
- COMPOGHD
- Status last verified
- Jun 2026
- First submitted
- 17 Dec 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kopchick JJ, Berryman DE, Puri V, Lee KY, Jorgensen JOL. The effects of growth hormone on adipose tissue: old observations, new mechanisms. Nat Rev Endocrinol. 2020 Mar;16(3):135-146. doi: 10.1038/s41574-019-0280-9. Epub 2019 Nov 28.
PubMed 31780780de Fries Jensen L, Antavalis V, Odgaard-Jensen J, Rossi A, Pietropoli A, Hojby M. Efficacy and Safety of Somapacitan Relative to Somatrogon and Lonapegsomatropin in Pediatric Growth Hormone Deficiency: Systematic Literature Review and Network Meta-analysis. Adv Ther. 2024 Nov;41(11):4098-4124. doi: 10.1007/s12325-024-02966-y. Epub 2024 Sep 11.
PubMed 39261416
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Body Composition in Children Treated With Growth Hormone for the Indication of Isolated Non-acquired Growth Hormone Deficiency.
- ClinicalTrials.gov ID
- NCT07333521
- Acronym / sponsor ID
- COMPOGHD / APHP251216
- Keywords
- Isolated non-acquired growth hormone deficiency, Daily growth hormone therapy, Long-acting growth hormone treatments, Body mass index, Auxological measurements, Impedancemetry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 13 Jan 2034 (estimated)
- Study completion
- 13 Jan 2034 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The study concerns all children in the Department of Pediatric Endocrinology, Gynecology and Diabetology at Necker Enfants Malades University Hospital treated with growth hormone, with the daily form or the delayed form, for the indication of isolated non-acquired growth hormone deficiency, naive to growth hormone treatment or already being treated with growth hormone and wishing to change galenical. Auxological measurements and with the Zmetric impedance meter will be carried out at each visit of the child's usual follow-up, from the day of the start of growth hormone treatment, for 3 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with isolated non-acquired growth hormone deficiency naive to growth hormone treatment | – | Other: Auxological measurements and impedancemetryAll children in the Department of Pediatric Endocrinology, Gynecology and Diabetology at Necker Enfants Malades University Hospital treated with growth hormone, with the daily form or the delayed form, for the indication of isolated non-acquired growth hormone deficiency, naive to growth hormone treatment. |
| Patients with isolated non-acquired growth hormone deficiency treated with growth hormone | – | Other: Auxological measurements and impedancemetryAll children in the Department of Pediatric Endocrinology, Gynecology and Diabetology at Necker Enfants Malades University Hospital treated with growth hormone, with the daily form or the delayed form, for the indication of isolated non-acquired growth hormone deficiency, already being treated with growth hormone and wishing to change galenical. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All children in the Department of Pediatric Endocrinology, Gynecology and Diabetology at Necker Enfants Malades University Hospital treated with growth hormone, with the daily form or the delayed form, for the indication of isolated non-acquired growth hormone deficiency, naive to growth hormone treatment or already being treated with growth hormone and wishing to change galenical.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- BMI greater than +3 SD.
- Multiple pituitary insufficiency.
- Acquired growth hormone insufficiency.
- Patient with type 1 or type 2 diabetes.
- Known eating disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auxological measurements and impedancemetryAuxological measurements and with the Zmetric impedance meter will be carried out at each visit of the child's usual follow-up, from the day of the start of growth hormone treatment, for 3 years. | Other | Patients with isolated non-acquired growth hormone deficiency naive to growth hormone treatment |
| Auxological measurements and impedancemetryAuxological measurements and with the Zmetric impedance meter will be carried out at each visit of the child's usual follow-up, from the day of the change of the galenical of the growth hormone treatment, for 3 years. | Other | Patients with isolated non-acquired growth hormone deficiency treated with growth hormone |
Primary outcome
Body mass index
Time frame: At the start of treatment or new galenical, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months
Body mass index calculation at each visit of the child's usual follow-up, from the day of the start of growth hormone treatment or the change of the galenical and during 3 years.
6 secondary outcomes
Amount of muscle mass
Time frame: At the start of treatment or new galenical, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months
Amount of fat mass
Time frame: At the start of treatment or new galenical, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months
Bone mineral content
Time frame: At the start of treatment or new galenical, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months
Amount of extracellular and intracellular water
Time frame: At the start of treatment or new galenical, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months
Hydration of fat-free mass
Time frame: At the start of treatment or new galenical, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months
Description of the efficacy and tolerance of growth hormone treatment
Time frame: At the start of treatment or new galenical, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Background: PubMed 31780780Kopchick JJ, Berryman DE, Puri V, Lee KY, Jorgensen JOL. The effects of growth hormone on adipose tissue: old observations, new mechanisms. Nat Rev Endocrinol. 2020 Mar;16(3):135-146. doi: 10.1038/s41574-019-0280-9. Epub 2019 Nov 28.
- Background: PubMed 39261416de Fries Jensen L, Antavalis V, Odgaard-Jensen J, Rossi A, Pietropoli A, Hojby M. Efficacy and Safety of Somapacitan Relative to Somatrogon and Lonapegsomatropin in Pediatric Growth Hormone Deficiency: Systematic Literature Review and Network Meta-analysis. Adv Ther. 2024 Nov;41(11):4098-4124. doi: 10.1007/s12325-024-02966-y. Epub 2024 Sep 11.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michel MD, PhD POLAK, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Dinane MD SAMARA-BOUSTANI, MD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Isolated Non-acquired Growth Hormone Deficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michel MD, PhD POLAK, MD, PhD (01 44 49 48 02 ext. +33, michel.polak@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (time frame: At the start of treatment or new galenical, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07333521, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.