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

A Prospective, Non-interventional (NIS), Long-term, Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin

Who can join

Ages 1 to 18 · All sexes

Inclusion Criteria:

* 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 Criteria:

* 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

About the study

The goal of this study is to further characterise the potential long-term safety risks of lonapegsomatropin in patients treated with lonapegsomatropin under real-world conditions in the post-marketing setting.

What is being tested

• No intervention (drug)

Sponsor: Ascendis Pharma Endocrinology Division A/S · Participants: 500 · Started: Mar 20, 2023

Contact the study team

• Deborah Bowlby · Phone: +1 844-442-7236

Official record on ClinicalTrials.gov — NCT05775523

Locations in the U.S.

Conditions

• Pituitary Dwarfism

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.