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

March 31, 2026 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Scotland
      • Glasgow, Scotland, United Kingdom
        • University of Glasgow

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Paediatric participants with growth hormone deficiency

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Somapacitan
Participants will be treated with commercially available somapacitan according to routine clinical practice at the discretion of the treating physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse drug reactions
Time Frame: From baseline (week 0) to end of study (up to 10 years)
Measured as count of events.
From baseline (week 0) to end of study (up to 10 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline (week 0) to end of study (up to 10 years)
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).
From baseline (week 0) to end of study (up to 10 years)
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).
From baseline (week 0) to end of study (up to 10 years)
Height velocity
Time Frame: From baseline (week 0) to end of study (up to 10 years)
measured as centimeter per year (cm/year).
From baseline (week 0) to end of study (up to 10 years)
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.
From baseline (week 0) to end of study (up to 10 years)
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.
From baseline (week 0) to end of study (up to 10 years)
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.
From baseline (week 0) to end of study (up to 10 years)
Change in bone age (measured as years)
Time Frame: From baseline (week 0) to end of study (up to 10 years)
Measured as years.
From baseline (week 0) to end of study (up to 10 years)
Change in bone age (measured as months)
Time Frame: From baseline (week 0) to end of study (up to 10 years)
Measured as months.
From baseline (week 0) to end of study (up to 10 years)
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.
at 10 year
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.
From baseline (week 0) to end of study (up to 10 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2024

Primary Completion (Estimated)

April 14, 2034

Study Completion (Estimated)

April 14, 2034

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN8640-4787
  • U1111-1294-5941 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisktrials.com

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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