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Observational study on the effectiveness and safety of SKYTROFA for growth hormone deficiency

A US Multi-center, Prospective, Non-interventional, Long Term, Effectiveness and Safety Study of Patients Treated With SKYTROFA (Lonapegsomatropin)

Observational Ascendis Pharma A/S · NCT05820672

This study is testing how well and safely SKYTROFA works for people with growth hormone deficiency by looking at their experiences during regular treatment.

Quick facts

Study typeObservational
Enrollment900 (estimated)
SexAll
SponsorAscendis Pharma A/S Industry-sponsored
Locations27 sites (Phoenix, Arizona and 26 other locations)
Trial IDNCT05820672 on ClinicalTrials.gov

What this trial studies

This study aims to gather evidence on the long-term effectiveness and safety of SKYTROFA (lonapegsomatropin) in patients diagnosed with growth hormone deficiency. Patients will receive treatment as per routine clinical practice without any additional visits or tests beyond standard care, except for specific clinical outcome assessments. The study will focus on real-world data to better understand the treatment's impact over time.

Who should consider this trial

Good fit: Ideal candidates for this study are patients currently being treated with SKYTROFA and managed clinically in the USA.

Not a fit: Patients participating in any interventional clinical study will not benefit from this observational study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of SKYTROFA for patients with growth hormone deficiency.

How similar studies have performed: Other studies have shown success in gathering real-world evidence for similar treatments, making this approach both relevant and valuable.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Patients who are on treatment with SKYTROFA (lonapegsomatropin)
* Patients being clinically managed in USA
* Patients with an appropriate written informed consent/assent as applicable for the age of the patient

Exclusion Criteria:

* Patients participating in any interventional clinical study

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 HormoneSKYTROFA
Last reviewed 2026-06-13 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.