Recruiting

Lonapegsomatropin

Sponsor:

Ascendis Pharma Endocrinology Division A/S

Code:

NCT05775523

Conditions

Growth Hormone Deficiency

Eligibility Criteria

Sex: All

Age: 1 - 18

Healthy Volunteers: Not accepted

Interventions

No intervention

Study Details

Brief summary:

The goal of this study is to further characterise the potential long-term safety risks of lonapegsomatropin in patients treated with lonapegsomatropin under real-world conditions in the post-marketing setting.

Conditions

Growth Hormone Deficiency

Study ID

NCT05775523

Start date

Mar 20, 2023

Status verified date

Feb, 2026

Completion date

Mar, 2033

Anticipated

Primary completion date

Mar, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Paediatric patients with GHD who are on treatment with lonapegsomatropin
  • Patients being clinically managed in Europe or the USA
  • Appropriate written informed consent/assent as applicable for the age of the patient
  • Patients willing to comply with follow-up requirements of the study

Exclusion Criteria:

  • Patients participating in any interventional clinical trial for short stature
  • Patients being treated with a GH or IGF-1 therapy, other than lonapegsomatropin, at enrollment
  • Patients for whom treatment with lonapegsomatropin is contraindicated
  • Patients with closed epiphyses
  • Patients with active malignant tumours
  • Patients under antitumour therapy within the past 12 months prior to instituting GH therapy
  • Hypersensitivity to somatropin or any of the excipients in lonapegsomatropin

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients on SKYTROFA (Lonapegsomatropin)Treatment

SKYTROFA (Lonapegsomatropin) administered once-weekly by subcutaneous injection

Interventions

No intervention

No intervention

Primary outcome measure

  • Occurrence of neoplasms (benign, malignant and unspecified) [ Time Frame: 5 years ]
  • Occurrence of type 2 diabetes mellitus [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Deborah Bowlby

+1 844-442-7236SkyPASS_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

Feb 4, 2026

Last verified

Feb, 2026

Keywords

  • Human Growth Hormone
  • hGH
  • rhGH
  • GHD
  • Long Acting Growth Hormone
  • Lonapegsomatropin
  • Prodrug
  • Growth Failure
  • Growth Hormone Replacement Therapy
  • Sustained Release Growth Hormone
  • Growth Hormone Deficiency
  • TransCon hGH
  • Skytrofa
  • SkyPASS

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 2026-02-04.