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NCT Number: NCT06709040

A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters

The aim of this study is to look at the long-term safety and clinical parameters of somapacitan in paediatric participants with growth hormone deficiency under routine clinical practice conditions. The study population will include 400 paediatric growth hormone deficient participants from the Global Registry for Novel Therapies in Rare Bone and Endocrine Conditions (GloBE-Reg) treated with once-weekly somapacitan and fulfilling the eligibility criteria of the study. The total duration of the study is planned to 10 years consisting of a 5-year recruitment period in the GLoBE-Reg followed by a 5-year follow-up period.

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Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Diabetes Mellitus Diabetes Mellitus Type 2 Diabetes Mellitus, Type 2 Dwarfism Dwarfism, Pituitary Endocrine System Diseases Glucose Metabolism Disorders Hypopituitarism Hypothalamic Diseases Metabolic Diseases Musculoskeletal Diseases Neoplasms Nervous System Diseases Nutritional and Metabolic Diseases Pituitary Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Glasgow

Glasgow, Scotland, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Treated with commercially available somapacitan according to local practice at the discretion of the physician.
  • Primary confirmed diagnosis of growth hormone deficiency as per local practice.
  • Male or female below 18 years of age at the time of signing informed consent in the GLoBE-Reg.

Exclusion criteria

  • Participants with active malignancy or in treatment for active pre-existing malignancy.

Treatment and study plan

Somapacitan

Drug

Participants will be treated with commercially available somapacitan according to routine clinical practice at the discretion of the treating physician.

Primary outcomes

  1. Number of adverse drug reactions

    Time frame: From baseline (week 0) to end of study (up to 10 years)

    Measured as count of events.

Secondary outcomes

  1. Number of medication errors (incorrect dose administration)

    Time frame: From baseline (week 0) to end of study (up to 10 years)

    Measured as count of errors.

  2. Number of participants with incident neoplasm

    Time frame: From baseline (week 0) to end of study (up to 10 years)

    Measured as number of participants (yes/no).

  3. Number of participants with incident diabetes mellitus type 2

    Time frame: From baseline (week 0) to end of study (up to 10 years)

    Measured as number of participants (yes/no).

  4. Height velocity

    Time frame: From baseline (week 0) to end of study (up to 10 years)

    measured as centimeter per year (cm/year).

  5. Change in height velocity standard deviation score (HVSDS)

    Time frame: From baseline (week 0) to end of study (up to 10 years)

    Measured as score ranging from -10 to +10.

  6. Change in height standard deviation score (HSDS)

    Time frame: From baseline (week 0) to end of study (up to 10 years)

    Measured as score ranging from -10 to +10.

  7. Change in insulin-like growth factor I (IGF-I) standard deviation score (SDS)

    Time frame: From baseline (week 0) to end of study (up to 10 years)

    Measured as score ranging from -10 to +10.

  8. Change in bone age (measured as years)

    Time frame: From baseline (week 0) to end of study (up to 10 years)

    Measured as years.

  9. Change in bone age (measured as months)

    Time frame: From baseline (week 0) to end of study (up to 10 years)

    Measured as months.

  10. Participants reaching near adult height

    Time frame: at 10 year

    Near adult height defined as: height velocity <2 cm/year over the last 9 months and chronological age >16 years (males) or >15 years (females) or bone age >16 years (males) and > 15 years (females). Measured as number of participants (yes/no). Only for those who are expected to reach near adult height during the study.

  11. Change in height SDS in participants reaching near adult height

    Time frame: From baseline (week 0) to end of study (up to 10 years)

    Near adult height can be defined as: height velocity <2 cm/year over the last 9 months and chronological age >16 years (males) or >15 years (females) or bone age >16 years (males) and > 15 years (females). Measured as score ranging from -10 to +10. Only for those who are expected to reach near adult height during the study.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Non-interventional, Observational, Registry-based Study to Investigate Long-term Safety and Clinical Parameters of Somapacitan Treatment in Paediatric Patients With Growth Hormone Deficiency During Routine Clinical Practice

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Nov 29, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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