A Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin

Last updated: October 24, 2025
Sponsor: Ascendis Pharma Endocrinology Division A/S
Overall Status: Active - Recruiting

Phase

N/A

Condition

Severe Short Stature

Hormone Deficiencies

Growth Hormone Deficiencies/abnormalities

Treatment

No intervention

Clinical Study ID

NCT05775523
ASND0033
  • Ages 1-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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, atenrollment

  • 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 GHtherapy

  • Hypersensitivity to somatropin or any of the excipients in lonapegsomatropin

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: No intervention
Phase:
Study Start date:
March 20, 2023
Estimated Completion Date:
March 31, 2033

Connect with a study center

  • Ascendis Investigational Site

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Ascendis Investigational Site

    Phoenix 5308655, Arizona 5551752 85054
    United States

    Active - Recruiting

  • Ascendis Investigational Site

    Sacramento, California 95821
    United States

    Site Not Available

  • Ascendis Investigational Site

    San Francisco, California 94143
    United States

    Site Not Available

  • Ascendis Investigational Site

    Sacramento 5389489, California 5332921 95821
    United States

    Active - Recruiting

  • Ascendis Investigational Site

    San Francisco 5391959, California 5332921 94143
    United States

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Centennial, Colorado 80112
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Centennial 5416541, Colorado 5417618 80112
    United States

    Active - Recruiting

  • Ascendis Investigational Site

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Ascendis Investigational Site

    Washington D.C. 4140963, District of Columbia 4138106 20010
    United States

    Active - Recruiting

  • Ascendis Investigational Site

    Orlando, Florida 32806
    United States

    Site Not Available

  • Ascendis Investigational Site

    Tampa, Florida 33612
    United States

    Site Not Available

  • Ascendis Investigational Site

    Orlando 4167147, Florida 4155751 32827
    United States

    Active - Recruiting

  • Ascendis Investigational Site

    Tampa 4174757, Florida 4155751 33612
    United States

    Active - Recruiting

  • Ascendis Investigational Site

    Sandy Springs, Georgia 30350
    United States

    Site Not Available

  • Ascendis Investigational Site

    Sandy Springs 4221333, Georgia 4197000 30350
    United States

    Active - Recruiting

  • Ascendis Investigational Site

    Boise, Idaho 83712
    United States

    Site Not Available

  • Ascendis Investigational Site

    Boise 5586437, Idaho 5596512 83712
    United States

    Active - Recruiting

  • Ascendis Investigational Site

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Ascendis Investigational Site

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Active - Recruiting

  • Ascendis Investigational Site

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Ascendis Investigational Site

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Active - Recruiting

  • Ascendis Investigational Site

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Ascendis Investigational Site

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Active - Recruiting

  • Ascendis Investigational Site

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Ascendis Investigational Site

    Minneapolis 5037649, Minnesota 5037779 55455
    United States

    Active - Recruiting

  • Ascendis Investigational Site

    Las Vegas, Nevada 89113
    United States

    Site Not Available

  • Ascendis Investigational Site

    Las Vegas 5506956, Nevada 5509151 89113
    United States

    Active - Recruiting

  • Ascendis Investigational Site

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Ascendis Investigational Site

    Lebanon 5088597, New Hampshire 5090174 03756
    United States

    Active - Recruiting

  • Ascendis Investigational Site

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Ascendis Investigational Site

    Morristown 5101427, New Jersey 5101760 07960
    United States

    Active - Recruiting

  • Ascendis Investigational Site

    New Hyde Park, New York 11042
    United States

    Site Not Available

  • Ascendis Investigational Site

    New Hyde Park 5128514, New York 5128638 11042
    United States

    Active - Recruiting

  • Ascendis Investigational Site

    Portland, Oregon 97239
    United States

    Site Not Available

  • Ascendis Investigational Site

    Portland 5746545, Oregon 5744337 97239
    United States

    Active - Recruiting

  • Ascendis Investigational Site

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • Ascendis Investigational Site

    Columbia 4575352, South Carolina 4597040 29203
    United States

    Active - Recruiting

  • Ascendis Investigational Site

    El Paso, Texas 79938
    United States

    Site Not Available

  • Ascendis Investigational Site

    El Paso 5520993, Texas 4736286 79938
    United States

    Active - Recruiting

  • Ascendis Investigational Site

    Norfolk, Virginia 23505
    United States

    Site Not Available

  • Ascendis Investigational Site

    Norfolk 4776222, Virginia 6254928 23505
    United States

    Active - Recruiting

  • Ascendis Investigational Site

    Seattle, Washington 98105
    United States

    Site Not Available

  • Ascendis Investigational Site

    Seattle 5809844, Washington 5815135 98105
    United States

    Active - Recruiting

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