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

NCT06709040 · tracked via the Priya Life Science UK tracker

Sponsor

Novo Nordisk A/S

Phase

Observational

Started

2024-12-13

Last updated

2026-04-06

Condition(s) studied

Growth Hormone DeficiencyNeoplasmsDiabetes Mellitus Type 2

Investigational drug(s) / intervention(s)

Somapacitan →

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

Study summary

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.

Eligibility

Sex

ALL

Min age

—

Max age

18 Years

Healthy volunteers

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.

Primary outcome measure(s)

Number of adverse drug reactions — From baseline (week 0) to end of study (up to 10 years)
Measured as count of events.

Trial sites (1)

Facility	City	Region	Status
University of Glasgow	Glasgow	Scotland

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06709040 on ClinicalTrials.gov ↗ ← All trials in the UK