Actively Recruiting
A Prospective, Non-interventional, Long-term Post-Authorisation Safety Study of Patients Treated With Lonapegsomatropin
Led by Ascendis Pharma Endocrinology Division A/S · Updated on 2026-02-04
500
Participants Needed
27
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety of lonapegsomatropin in children with growth hormone deficiency who are already being treated with this medication. This study is observational and aims to gather real-world safety data over time after the drug has been authorized for use. The focus is on monitoring potential risks such as the development of tumors and type 2 diabetes over a period of five years. Participants receive lonapegsomatropin, administered once weekly by subcutaneous injection as part of their usual care. The study does not involve additional interventions but observes patients who are already treated with this therapy. The observational period extends for at least five years to collect safety data and compare it with historical information from previous studies. During the study, researchers will monitor for the occurrence of benign and malignant tumors, type 2 diabetes, and other adverse events affecting the kidneys, liver, immune system, and nervous system. They will also track medication errors and measure the response of Insulin-like Growth Factor-1 (IGF-1) to treatment. Participants are followed up regularly to collect this information, with the study lasting until March 2033.
CONDITIONS
Brief Title
A Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Paediatric patients with growth hormone deficiency who are on treatment with lonapegsomatropin
- Patients being clinically managed in Europe or the USA
- Appropriate written informed consent or assent as applicable for the age of the patient
- Patients willing to comply with follow-up requirements of the study
You will not qualify if you...
- Patients participating in any interventional clinical trial for short stature
- Patients being treated with a growth hormone or IGF-1 therapy other than lonapegsomatropin at enrollment
- Patients for whom treatment with lonapegsomatropin is contraindicated
- Patients with closed growth plates (epiphyses)
- Patients with active malignant tumors
- Patients under antitumor therapy within the past 12 months prior to starting growth hormone therapy
- Hypersensitivity to somatropin or any of the ingredients in lonapegsomatropin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants who undergo routine care with lonapegsomatropin are observed for safety outcomes over several years.
Periodic visits as part of routine clinical management
Trial Site Locations
Total: 27 locations
1
Ascendis Investigational Site
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Ascendis Investigational Site
Orange, California, United States, 92868
Actively Recruiting
3
Ascendis Investigational Site
Sacramento, California, United States, 95821
Actively Recruiting
4
Ascendis Investigational Site
San Francisco, California, United States, 94143
Actively Recruiting
5
Ascendis Pharma Investigational Site
Centennial, Colorado, United States, 80112
Actively Recruiting
6
Ascendis Investigational Site
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
7
Ascendis Investigational Site
Orlando, Florida, United States, 32806
Actively Recruiting
8
Ascendis Investigational Site
Orlando, Florida, United States, 32827
Actively Recruiting
9
Ascendis Investigational Site
Tampa, Florida, United States, 33612
Actively Recruiting
10
Ascendis Investigational Site
Sandy Springs, Georgia, United States, 30350
Actively Recruiting
11
Ascendis Investigational Site
Boise, Idaho, United States, 83712
Actively Recruiting
12
Ascendis Investigational Site
Indianapolis, Indiana, United States, 46202
Actively Recruiting
13
Ascendis Investigational Site
Iowa City, Iowa, United States, 52242
Actively Recruiting
14
Ascendis Investigational Site
Louisville, Kentucky, United States, 40202
Actively Recruiting
15
Ascendis Investigational Site
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
16
Ascendis Investigational Site
Las Vegas, Nevada, United States, 89113
Actively Recruiting
17
Ascendis Investigational Site
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
18
Ascendis Investigational Site
Manchester, New Hampshire, United States, 03104
Actively Recruiting
19
Ascendis Investigational Site
Morristown, New Jersey, United States, 07960
Actively Recruiting
20
Ascendis Investigational Site
New Hyde Park, New York, United States, 11042
Actively Recruiting
21
Ascendis Investigational Site
Cincinnati, Ohio, United States, 45229
Actively Recruiting
22
Ascendis Investigational Site
Portland, Oregon, United States, 97239
Actively Recruiting
23
Ascendis Investigational Site
Columbia, South Carolina, United States, 29203
Actively Recruiting
24
Ascendis Investigational Site
Dallas, Texas, United States, 75390
Actively Recruiting
25
Ascendis Investigational Site
El Paso, Texas, United States, 79907
Actively Recruiting
26
Ascendis Investigational Site
Norfolk, Virginia, United States, 23507
Actively Recruiting
27
Ascendis Investigational Site
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
D
Deborah Bowlby
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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