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NCT Number: NCT05820672

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

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

Recruiting

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Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Ascendis Investigational Site, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Assess the safety of patients treated with SKYTROFA (Lonapegsomatropin)

    Time frame: 5 years

    Incidence of Adverse Events and Serious Adverse Events

  2. Assess the effectiveness of patients treated with SKYTROFA (Lonapegsomatropin)

    Time frame: 5 years

    Near adult height (cm)

Secondary outcomes

  1. Assess clinical outcome assessments (COAs)

    Time frame: 5 years

    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))

  2. Assess clinical outcome assessments (COAs)

    Time frame: 5 years

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Deborah Bowlby

CONTACT

[email protected]

+1 844-442-7236

Sponsors and collaborators

Lead sponsor

Ascendis Pharma Endocrinology Division A/S

Industry

Registry information

Official study title

A US Multi-center, Prospective, Non-interventional, Long Term, Effectiveness and Safety Study of Patients Treated With SKYTROFA (Lonapegsomatropin)

Acronym: SkybriGHt

Important dates

Study start
2023
Primary completion
2033
Study completion
2033
First posted
Apr 20, 2023
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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