Growth Hormone DeficiencySkybriGHtNCT05820672
A US Non-interventional, Effectiveness and Safety Study of Patients Treated With SKYTROFA
An observational study of Growth Hormone Deficiency, run by Ascendis Pharma Endocrinology Division A/S at 27 sites in United States.
Trial summary
The goal of this study is to genrate evidence on long-term effectiveness and safety of SKYTROFA (lonapegsomatropin) in patients with growth hormone deficiency under routine clinical care Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Growth Hormone Deficiency
- How many people
- 900 participants
- Where
- 27 sitesUnited States
- Study dates
- 20 Mar 2023to Mar 2033
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients being treated with SKYTROFA who are associated to selected endocrinology or pediatric clinics across USA.
Who may be able to join
- 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
Who cannot join
- Patients participating in any interventional clinical study
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
United States27 sites, 27 recruiting
- Recruiting
Ascendis Investigational Site
Boise, Idaho, 83712
- Recruiting
Ascendis Pharma Investigational Site
Centennial, Colorado, 80112
- Recruiting
Ascendis Investigational Site
Cincinnati, Ohio, 45229
- Recruiting
Ascendis Investigational Site
Columbia, South Carolina, 29203
- Recruiting
Ascendis Investigational Site
Dallas, Texas, 75390
- Recruiting
Ascendis Investigational Site
El Paso, Texas, 79907
- Recruiting
Ascendis Investigational Site
Indianapolis, Indiana, 46202
- Recruiting
Ascendis Investigational Site
Iowa City, Iowa, 52242
- Recruiting
Ascendis Investigational Site
Las Vegas, Nevada, 89113
- Recruiting
Ascendis Investigational Site
Lebanon, New Hampshire, 03756
- Recruiting
Ascendis Investigational Site
Louisville, Kentucky, 40202
- Recruiting
Ascendis Investigational Site
Manchester, New Hampshire, 03104
- Recruiting
Ascendis Investigational Site
Minneapolis, Minnesota, 55455
- Recruiting
Ascendis Investigational Site
Morristown, New Jersey, 07960
- Recruiting
Ascendis Investigational Site
New Hyde Park, New York, 11042
- Recruiting
Ascendis Investigational Site
Norfolk, Virginia, 23507
- Recruiting
Ascendis Investigational Site
Orange, California, 92868
- Recruiting
Ascendis Investigational Site
Orlando, Florida, 32806
- Recruiting
Ascendis Investigational Site
Orlando, Florida, 32827
- Recruiting
Ascendis Investigational Site
Phoenix, Arizona, 85054
- Recruiting
Ascendis Investigational Site
Portland, Oregon, 97239
- Recruiting
Ascendis Investigational Site
Sacramento, California, 95821
- Recruiting
Ascendis Investigational Site
San Francisco, California, 94143
- Recruiting
Ascendis Investigational Site
Sandy Springs, Georgia, 30350
- Recruiting
Ascendis Investigational Site
Seattle, Washington, 98105
- Recruiting
Ascendis Investigational Site
Tampa, Florida, 33612
- Recruiting
Ascendis Investigational Site
Washington D.C., District of Columbia, 20010
About this study
Official title: A US Multi-center, Prospective, Non-interventional, Long Term, Effectiveness and Safety Study of Patients Treated With SKYTROFA (Lonapegsomatropin)
The goal of this study is to genrate evidence on long-term effectiveness and safety of SKYTROFA (lonapegsomatropin) in patients with growth hormone deficiency under routine clinical care
Read the detailed description
Patients will be treated according to routine clinical practice, and no additional visits, examinations or tests will be required beyond those performed as part of routine clinical practice except for COAs.
- Conditions
- Growth Hormone Deficiency
- Being tested
- No intervention
- Keywords
- Human Growth Hormone, SKYTROFA
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients on SKYTROFA Treatment | Patients on SKYTROFA Treatment managed in USA with appropriate written Informed Consent Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety of patients treated with SKYTROFA (Lonapegsomatropin)
Incidence of Adverse Events and Serious Adverse Events
Measured: 5 years
Assess the effectiveness of patients treated with SKYTROFA (Lonapegsomatropin)
Near adult height (cm)
Measured: 5 years
Secondary outcomes (2)
Assess clinical outcome assessments (COAs)
Change in Quality of Life in Short Stature Youth (QoLISSY) scores from baseline through End of Study (QOLISSY scores range on a scale of 0 to 100 with higher scores representing better quality of life. (For both child and parent version))
Measured: 5 years
Assess clinical outcome assessments (COAs)
Change in Treatment Satisfaction Questionnaire for Medicine (TSQM-9) scores from baseline through End of Study (The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start20 Mar 2023
- Primary completionMar 2033 (estimated)
- Study completionMar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Ascendis Pharma Endocrinology Division A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Ascendis Pharma A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820672
- Sponsor's protocol ID
- ASND0037
- Acronym
- SkybriGHt
- Status last verified
- Apr 2026
- First submitted
- 7 Mar 2023
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A US Multi-center, Prospective, Non-interventional, Long Term, Effectiveness and Safety Study of Patients Treated With SKYTROFA (Lonapegsomatropin)
- ClinicalTrials.gov ID
- NCT05820672
- Acronym / sponsor ID
- SkybriGHt / ASND0037
- Conditions
- Growth Hormone Deficiency
- Keywords
- Human Growth Hormone, SKYTROFA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Ascendis Pharma Endocrinology Division A/SIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- Mar 2033 (estimated)
- Study completion
- Mar 2033 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to genrate evidence on long-term effectiveness and safety of SKYTROFA (lonapegsomatropin) in patients with growth hormone deficiency under routine clinical care
Detailed description
Patients will be treated according to routine clinical practice, and no additional visits, examinations or tests will be required beyond those performed as part of routine clinical practice except for COAs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients on SKYTROFA Treatment | – | Other: No interventionPatients on SKYTROFA Treatment managed in USA with appropriate written Informed Consent |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients being treated with SKYTROFA who are associated to selected endocrinology or pediatric clinics across USA.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients participating in any interventional clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Patients on SKYTROFA Treatment |
Primary outcome
Assess the safety of patients treated with SKYTROFA (Lonapegsomatropin)
Time frame: 5 years
Incidence of Adverse Events and Serious Adverse Events
Assess the effectiveness of patients treated with SKYTROFA (Lonapegsomatropin)
Time frame: 5 years
Near adult height (cm)
2 secondary outcomes
Assess clinical outcome assessments (COAs)
Time frame: 5 years
Assess clinical outcome assessments (COAs)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Growth Hormone Deficiency
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingPhase 3
Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
Growth Disorders, Growth Failure
RecruitingPhase 3
Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
Growth Hormone Deficiency (GHD)
RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury
Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director, MD study director
Ascendis Pharma A/S
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Deficiency, run by Ascendis Pharma Endocrinology Division A/S at 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deborah Bowlby (+1 844-442-7236, Skybright_contact@ascendispharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the safety of patients treated with SKYTROFA (Lonapegsomatropin) (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.