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Observational Study of SKYTROFA for Growth Hormone Deficiency

This study is looking at how well and how safely SKYTROFA (lonapegsomatropin) works for people with growth hormone deficiency in their everyday medical care. It's an observational study, meaning you would receive SKYTROFA as part of your usual treatment, and researchers would collect information from your medical records. The study aims to understand the long-term effectiveness and safety of SKYTROFA over five years. You can join if you are already being treated with SKYTROFA, are managed by a doctor in the USA, and provide your consent. The study is currently unclear on its recruitment status.

Study design
This is an observational study with a planned enrollment of 900 participants. It is not a randomized trial, and there is no specified phase.
What's involved
You will be treated according to your routine clinical practice. No extra visits, exams, or tests are required beyond what your doctor normally does, except for COAs (Clinical Outcome Assessments).
Compensation
Not stated in the trial record.
Follow-up
The safety and effectiveness of SKYTROFA will be assessed over 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05820672

A US Non-interventional, Effectiveness and Safety Study of Patients Treated With SKYTROFA

Recruiting
Not specifiedAll AgesObservational
Ascendis Pharma Endocrinology Division A/S
~900 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:No intervention

At a glance

Recruiting sites
27 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assess the safety of patients treated with SKYTROFA (Lonapegsomatropin)
Measured over 5 years
+1 more outcome measured

Conditions

Growth Hormone Deficiency

Explore related trials

Growth Hormone Deficiency

Where it's being run

27 sites across 21 states
California3
Florida3
New Hampshire2
Texas2
Arizona1
Colorado1
District of Columbia1
Georgia1

Study leadership

  • Medical Director, MD · STUDY_DIRECTOR · Ascendis Pharma A/S

Who to contact

Deborah Bowlby
[email protected]
+1 844-442-7236
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Patients participating in any interventional clinical study

What this trial measures

  • Assess the safety of patients treated with SKYTROFA (Lonapegsomatropin)5 years

    Incidence of Adverse Events and Serious Adverse Events

  • Assess the effectiveness of patients treated with SKYTROFA (Lonapegsomatropin)5 years

    Near adult height (cm)