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Long-term safety of somapacitan in children with growth hormone deficiency

Follows children with growth hormone deficiency treated with somapacitan during routine care.

Key facts

Who runs it
Novo Nordisk A/S
Where
Glasgow, United KingdomSee the site
Trial code
Registry title
A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters
Status
Enrolling by invitation
People taking part
500 people, planned
Started
13 Dec 2024
Expected to end
14 Apr 2034
Type of study
Observational
Treatments tested
  • Somapacitan
Record updated
6 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers with growth hormone deficiency who are already treated with once-weekly somapacitan in routine care.

Age
Younger than 18 years when consent is signed in the registry.
Sex
Boys and girls can both join.
Disease stage
A confirmed main diagnosis of growth hormone deficiency, made as in local practice.
Earlier treatment
Must be treated with commercially available somapacitan according to local practice, at the doctor's discretion.

Main reasons for not taking part

  • Active cancer
  • Being treated for an existing active cancer

The registry criteria, word for word

Show all 4 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Where in United Kingdom

  • University of GlasgowGlasgow, United KingdomEnrolling by invitation

About the trial

What the trial wants to find out

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.

The group in the trial

  • Participants with Growth Hormone Deficieny

    The study is non-interventional as there are no interventions involved and decision to treat participants with commerically available somapacitan will be made at the treating physician's discretion prior to, and independently from, the decision to include the participants in the GLoBE-Reg registry. Novo Nordisk will not provide any products for included participants during the conduct of the study.

    Treatment: Somapacitan

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official 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
Plain-language title
Long-term safety of somapacitan in children with growth hormone deficiencyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
6 April 2026