Observational study on the effectiveness and safety of SKYTROFA for growth hormone deficiency
Official title: A US Multi-center, Prospective, Non-interventional, Long Term, Effectiveness and Safety Study of Patients Treated With SKYTROFA (Lonapegsomatropin)
Run by Ascendis Pharma A/S · NCT05820672 · Data updated 2026-11-12
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 type | Observational |
|---|---|
| Sex | All |
| Enrollment | 900 (estimated) |
| Sponsor | Ascendis Pharma A/S Industry-sponsored |
| Locations | 27 sites (Phoenix, Arizona and 26 other locations) |
| Status | Recruiting |
| Started | March 20, 2023 |
| Main results expected | March 2033 |
| Study ends | March 2033 |
| Registry record updated | April 21, 2026 |
| Trial ID | NCT05820672 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients currently being treated with SKYTROFA and managed clinically in the USA.
✕Probably not a fit
Patients participating in any interventional clinical study will not benefit from this observational study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown success in gathering real-world evidence for similar treatments, making this approach both relevant and valuable.
Who can join: the full rules
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 it's running
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Ascendis Investigational Site
Phoenix, Arizona, United States Recruiting -
Ascendis Investigational Site
Orange, California, United States Recruiting -
Ascendis Investigational Site
Sacramento, California, United States Recruiting -
Ascendis Investigational Site
San Francisco, California, United States Recruiting -
Ascendis Pharma Investigational Site
Centennial, Colorado, United States Recruiting -
Ascendis Investigational Site
Washington D.C., District of Columbia, United States Recruiting
Show 21 more locations
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Ascendis Investigational Site
Orlando, Florida, United States Recruiting -
Ascendis Investigational Site
Orlando, Florida, United States Recruiting -
Ascendis Investigational Site
Tampa, Florida, United States Recruiting -
Ascendis Investigational Site
Sandy Springs, Georgia, United States Recruiting -
Ascendis Investigational Site
Boise, Idaho, United States Recruiting -
Ascendis Investigational Site
Indianapolis, Indiana, United States Recruiting -
Ascendis Investigational Site
Iowa City, Iowa, United States Recruiting -
Ascendis Investigational Site
Louisville, Kentucky, United States Recruiting -
Ascendis Investigational Site
Minneapolis, Minnesota, United States Recruiting -
Ascendis Investigational Site
Las Vegas, Nevada, United States Recruiting -
Ascendis Investigational Site
Lebanon, New Hampshire, United States Recruiting -
Ascendis Investigational Site
Manchester, New Hampshire, United States Recruiting -
Ascendis Investigational Site
Morristown, New Jersey, United States Recruiting -
Ascendis Investigational Site
New Hyde Park, New York, United States Recruiting -
Ascendis Investigational Site
Cincinnati, Ohio, United States Recruiting -
Ascendis Investigational Site
Portland, Oregon, United States Recruiting -
Ascendis Investigational Site
Columbia, South Carolina, United States Recruiting -
Ascendis Investigational Site
Dallas, Texas, United States Recruiting -
Ascendis Investigational Site
El Paso, Texas, United States Recruiting -
Ascendis Investigational Site
Norfolk, Virginia, United States Recruiting -
Ascendis Investigational Site
Seattle, Washington, United States Recruiting
Study contacts
- Study coordinator: Deborah Bowlby
- Email: Skybright_contact@ascendispharma.com
- Phone: +1 844-442-7236
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Understanding growth hormone deficiency after a brain injury in adults
This observational study tests whether growth hormone deficiency affects quality of life and symptoms in adults with traumatic brain injury and whether GH replacement helps after 12 weeks.
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Belgians and Luxembourgians with childhood GHD: adult outcomes and follow-up
This study tests how adults who had childhood-onset growth hormone deficiency and were treated with rhGH fare in follow-up and ongoing treatment.
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Long-term safety assessment of lonapegsomatropin in children with growth hormone deficiency
This study looks at the long-term safety of lonapegsomatropin in children with growth hormone deficiency who are already being treated with it.
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Effects of growth hormone and liraglutide on appetite regulation
This study is testing if growth hormone and liraglutide can change appetite-related hormones in healthy adults and those with growth hormone deficiency to see how they affect weight and energy use.
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Evaluating the long-term safety and effectiveness of Growtropin®-II in children with short stature
This study is testing whether the Growtropin®-II treatment is safe and effective for children with short stature caused by various conditions, to see how it helps them grow and stay healthy over time.
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Evaluating long-term safety and effectiveness of growth hormone in children with various conditions
This study is testing how safe and effective growth hormone treatment is for children with conditions like Growth Hormone Deficiency and Turner Syndrome over the long term.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.