Actively Recruiting
A US Multi-center, Prospective, Non-interventional, Long Term, Effectiveness and Safety Study of Patients Treated With SKYTROFA (Lonapegsomatropin)
Led by Ascendis Pharma Endocrinology Division A/S · Updated on 2026-04-21
900
Participants Needed
27
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to gather long-term evidence on the safety and effectiveness of SKYTROFA (lonapegsomatropin) in patients with growth hormone deficiency who are receiving routine clinical care. The study focuses on understanding how patients respond to this treatment over time without altering their usual medical management. It is a non-interventional observational study conducted across multiple centers in the USA. Patients will continue their regular treatment with SKYTROFA as managed by their healthcare providers, with no additional visits, examinations, or tests required beyond standard clinical care. The study will collect data from clinical outcome assessments (COAs) to evaluate treatment results and safety over a period of five years. No experimental interventions or placebos are involved. Participants will be monitored through their routine clinical visits, with researchers reviewing their health status and treatment effectiveness using standard assessments. The primary outcomes include measuring safety and treatment effectiveness over five years, along with evaluating clinical outcomes through COAs. This approach allows for natural observation of patient experiences without extra procedures or disruptions to their care.
CONDITIONS
Brief Title
A US Non-interventional, Effectiveness and Safety Study of Patients Treated With SKYTROFA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who are on treatment with SKYTROFA (lonapegsomatropin)
- Patients being clinically managed in USA
- Patients with an appropriate written informed consent or assent as applicable for their age
You will not qualify if you...
- Patients participating in any interventional clinical study
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.
Duration - Up to 5 years
Participants who undergo routine care are observed to assess safety and effectiveness of SKYTROFA treatment over time.
Visits and assessments occur as part of routine clinical practice with no additional required visits
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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