πŸ›οΈ Verified NIH Record β€’ Updated 2026-05-12

A Trial to Investigate Different Doses of Lonapegsomatropin Compared to Somatropin in Individuals With Turner Syndrome (NCT05690386)

πŸ”΅ Active, Not Recruiting Phase2 πŸ’Š Investigational Drug / Biologic Sponsor: Ascendis Pharma Endocrinology Division A/S

🩺 Plain-English Summary (8th-Grade Level)

A 104 week dose finding open label trial followed by an optional 78 week open label extension of lonapegsomatropin, a long-acting growth hormone product, administered once-a-week versus daily somatropin product in prepubertal individuals with Turner syndrome. Approximately 48 individuals (12 individuals per arm) will be randomized to receive one of three doses of lonapegsomatropin or a daily injection of somatropin. This is a trial that will be conducted in the United States.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (18 items).

Location: Ascendis Pharma Investigational Site β€” Palo Alto, California

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Turner Syndrome with presence of Y-chromosomal material on genetic testing and without a history of gonadectomy.
  • Diagnosis of diabetes mellitus.
  • Known history of clinically relevant conditions that may have an effect on growth, e.g. but not limited to celiac disease, malnutrition, treatment with potential growth-influencing medications for Attention-deficit/ hyperactivity disorder (ADHD), etc.
  • Any known, clinically significant, congenital or acquired cardiac/cardiovascular dysfunction that might interfere with growth as determined by transthoracic echocardiogram.
  • Known history or presence of malignancy.
  • Individuals with history of intracranial tumor or cysts, with evidence of growth within the last 12 months prior to Screening. Note - Individuals with a history of intracranial tumor may be eligible if there is no evidence of residual tumor as determined by MRI/CT scan(s) performed within 6 to 12 months prior to screening.
  • Hepatic transaminases (i.e., AST or ALT) above 3 times the upper limit of normal according to the central laboratory at screening.
  • Major medical conditions and/or presence of contraindication to hGH treatment.
  • Abnormal renal function.
  • Clinically relevant systemic illness, acute critical illness, and complications following open heart surgery, abdominal surgery, multiple accidental traumas, acute respiratory failure, or similar conditions within 6 months prior to Screening.
  • Poorly controlled hypertension.

πŸ” Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

πŸ“ All Participating Trial Locations (19 Sites)

  • Ascendis Pharma Investigational Site β€” Palo Alto, California
  • Ascendis Pharma Investigational Site β€” San Diego, California
  • Ascendis Pharma Investigational Site β€” Aurora, Colorado
  • Ascendis Pharma Investigational Site β€” Orlando, Florida
  • Ascendis Pharma Investigational Site β€” St. Petersburg, Florida
  • Ascendis Pharma Investigational Site β€” Atlanta, Georgia
  • Ascendis Pharma Investigational Site β€” Idaho Falls, Idaho
  • Ascendis Pharma Investigational Site β€” Chicago, Illinois
  • Ascendis Pharma Investigational Site β€” Boston, Massachusetts
  • Ascendis Pharma Investigational Site β€” Saint Paul, Minnesota
  • Ascendis Pharma Investigational Site β€” Las Vegas, Nevada
  • Ascendis Pharma Investigational Site β€” Lake Success, New York
  • Ascendis Pharma Investigational Site β€” Chapel Hill, North Carolina
  • Ascendis Pharma Investigational Site β€” Cincinnati, Ohio
  • Ascendis Pharma Investigational Site β€” Oklahoma City, Oklahoma
  • Ascendis Pharma Investigational Site β€” Portland, Oregon
  • Ascendis Pharma Investigational Site β€” El Paso, Texas
  • Ascendis Pharma Investigational Site β€” Fort Worth, Texas
  • Ascendis Pharma Investigational Site β€” Seattle, Washington

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
πŸ›οΈ View Official NIH Record β†—