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Observational Study of Lonapegsomatropin for Growth Hormone Deficiency

This study is looking at the long-term safety of lonapegsomatropin in children and teenagers (ages 1 to 18) who have Growth Hormone Deficiency (GHD) and are already taking this medication. The goal is to understand if there are any risks, such as certain types of growths (neoplasms) or type 2 diabetes, over a 5-year period. You could be eligible if you are a pediatric patient with GHD, are currently being treated with lonapegsomatropin, and are receiving care in Europe or the USA. This is an observational study, meaning researchers will be watching how patients do in real-world conditions.

Study design
This is an observational study planning to include 500 participants. It is not an interventional trial, meaning you will not receive a new treatment as part of the study.
What's involved
You would need to be willing to comply with the follow-up requirements of the study. The specific visits or procedures are not detailed in the record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years to monitor for the occurrence of neoplasms and type 2 diabetes mellitus.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05775523

A Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin

Recruiting
Not specifiedAges 1–18Observational
Ascendis Pharma Endocrinology Division A/S
~500 participants
Updated 2026-02-04 on ClinicalTrials.gov
What's tested:No intervention

At a glance

Recruiting sites
27 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of neoplasms (benign, malignant and unspecified)
Measured over 5 years
+1 more outcome measured

Conditions

Growth Hormone Deficiency

Explore related trials

Growth Hormone Deficiency

Where it's being run

27 sites across 21 states
California3
Florida3
New Hampshire2
Texas2
Arizona1
Colorado1
District of Columbia1
Georgia1

Study leadership

  • Medical Director, MD · STUDY_DIRECTOR · Ascendis Pharma A/S

Who to contact

Deborah Bowlby
[email protected]
+1 844-442-7236
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Paediatric patients with GHD who are on treatment with lonapegsomatropin
Patients being clinically managed in Europe or the USA
Appropriate written informed consent/assent as applicable for the age of the patient
Patients willing to comply with follow-up requirements of the study

Exclusion

Patients participating in any interventional clinical trial for short stature
Patients being treated with a GH or IGF-1 therapy, other than lonapegsomatropin, at enrollment
Patients for whom treatment with lonapegsomatropin is contraindicated
Patients with closed epiphyses
Patients with active malignant tumours
Patients under antitumour therapy within the past 12 months prior to instituting GH therapy
Hypersensitivity to somatropin or any of the excipients in lonapegsomatropin

What this trial measures

  • Occurrence of neoplasms (benign, malignant and unspecified)5 years
  • Occurrence of type 2 diabetes mellitus5 years