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Long-term safety assessment of lonapegsomatropin in children with growth hormone deficiency

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

Observational Ascendis Pharma A/S · NCT05775523

This study looks at the long-term safety of lonapegsomatropin in children with growth hormone deficiency who are already being treated with it.

Quick facts

Study typeObservational
Enrollment500 (estimated)
Ages1 Year to 18 Years
SexAll
SponsorAscendis Pharma A/S Industry-sponsored
Locations27 sites (Phoenix, Arizona and 26 other locations)
Trial IDNCT05775523 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the long-term safety profile of lonapegsomatropin in pediatric patients diagnosed with growth hormone deficiency (GHD) who are currently receiving this treatment. By monitoring these patients in real-world clinical settings, the study seeks to identify any potential safety risks associated with lonapegsomatropin over time. The study does not involve any new interventions, focusing instead on the safety outcomes of patients already on treatment. Participants will be required to provide informed consent and comply with follow-up protocols.

Who should consider this trial

Good fit: Ideal candidates for this study are pediatric patients with growth hormone deficiency currently being treated with lonapegsomatropin.

Not a fit: Patients who are participating in other interventional trials for short stature or those with contraindications to lonapegsomatropin will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety of lonapegsomatropin, helping to ensure better management of growth hormone deficiency in children.

How similar studies have performed: While this study focuses on the long-term safety of an existing treatment, similar observational studies have previously demonstrated the importance of post-marketing safety assessments, suggesting a potential for valuable findings.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Phoenix, Arizona and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Growth Hormone DeficiencyHuman Growth HormonehGHrhGHGHDLong Acting Growth HormoneLonapegsomatropinProdrug
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.