Recruiting

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

Sponsor:

Ascendis Pharma Endocrinology Division A/S

Code:

NCT05820672

Conditions

Growth Hormone Deficiency

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

No intervention

Study Details

Brief 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

Conditions

Growth Hormone Deficiency

Study ID

NCT05820672

Start date

Mar 20, 2023

Status verified date

Apr, 2026

Completion date

Mar, 2033

Anticipated

Primary completion date

Mar, 2033

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

900 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients on SKYTROFA Treatment

Patients on SKYTROFA Treatment managed in USA with appropriate written Informed Consent

Interventions

No intervention

Primary outcome measure

Assess the safety of patients treated with SKYTROFA (Lonapegsomatropin) [ Time Frame: 5 years ]
Assess the effectiveness of patients treated with SKYTROFA (Lonapegsomatropin) [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Deborah Bowlby

+1 844-442-7236 Skybright_contact@ascendispharma.com

Locations

Ascendis Investigational Site

Recruiting

Phoenix, Arizona, United States, 85054

Ascendis Investigational Site

Recruiting

Orange, California, United States, 92868

Ascendis Investigational Site

Recruiting

Sacramento, California, United States, 95821

Ascendis Investigational Site

Recruiting

San Francisco, California, United States, 94143

Ascendis Pharma Investigational Site

Recruiting

Centennial, Colorado, United States, 80112

Ascendis Investigational Site

Recruiting

Washington D.C., District of Columbia, United States, 20010

Ascendis Investigational Site

Recruiting

Orlando, Florida, United States, 32806

Ascendis Investigational Site

Recruiting

Orlando, Florida, United States, 32827

Ascendis Investigational Site

Recruiting

Tampa, Florida, United States, 33612

Ascendis Investigational Site

Recruiting

Sandy Springs, Georgia, United States, 30350

Ascendis Investigational Site

Recruiting

Boise, Idaho, United States, 83712

Ascendis Investigational Site

Recruiting

Indianapolis, Indiana, United States, 46202

Ascendis Investigational Site

Recruiting

Iowa City, Iowa, United States, 52242

Ascendis Investigational Site

Recruiting

Louisville, Kentucky, United States, 40202

Ascendis Investigational Site

Recruiting

Minneapolis, Minnesota, United States, 55455

Ascendis Investigational Site

Recruiting

Las Vegas, Nevada, United States, 89113

Ascendis Investigational Site

Recruiting

Lebanon, New Hampshire, United States, 03756

Ascendis Investigational Site

Recruiting

Manchester, New Hampshire, United States, 03104

Ascendis Investigational Site

Recruiting

Morristown, New Jersey, United States, 07960

Ascendis Investigational Site

Recruiting

New Hyde Park, New York, United States, 11042

Ascendis Investigational Site

Recruiting

Cincinnati, Ohio, United States, 45229

Ascendis Investigational Site

Recruiting

Portland, Oregon, United States, 97239

Ascendis Investigational Site

Recruiting

Columbia, South Carolina, United States, 29203

Ascendis Investigational Site

Recruiting

Dallas, Texas, United States, 75390

Ascendis Investigational Site

Recruiting

El Paso, Texas, United States, 79907

Ascendis Investigational Site

Recruiting

Norfolk, Virginia, United States, 23507

Ascendis Investigational Site

Recruiting

Seattle, Washington, United States, 98105

More Information

Sponsor

Ascendis Pharma Endocrinology Division A/S

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

Human Growth Hormone
SKYTROFA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ascendis Pharma Endocrinology Division A/S on 2026-04-21.