A Trial to Investigate Different Doses of Lonapegsomatropin Compared to Somatropin in Individuals With Turner Syndrome
NCT ID: NCT05690386
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
48 participants
INTERVENTIONAL
2023-02-15
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lonapegsomatropin at 0.24 mg hGH/kg/week
Lonapegsomatropin at 0.24 mg hGH/kg/week administered once-weekly by subcutaneous injection
Lonapegsomatropin
Once-weekly subcutaneous injection of Lonapegsomatropin
Lonapegsomatropin at 0.30 mg hGH/kg/week
Lonapegsomatropin at 0.30 mg hGH/kg/week administered once-weekly by subcutaneous injection
Lonapegsomatropin
Once-weekly subcutaneous injection of Lonapegsomatropin
Lonapegsomatropin at 0.36 mg hGH/kg/week
Lonapegsomatropin at 0.36 mg hGH/kg/week administered once-weekly by subcutaneous injection
Lonapegsomatropin
Once-weekly subcutaneous injection of Lonapegsomatropin
Somatropin at 0.05 mg/kg/day
Somatropin at 0.05 mg/kg/day administered once-daily by subcutaneous injection
Somatropin
Once-daily subcutaneous injection of Somatropin
Interventions
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Lonapegsomatropin
Once-weekly subcutaneous injection of Lonapegsomatropin
Somatropin
Once-daily subcutaneous injection of Somatropin
Eligibility Criteria
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Inclusion Criteria
2. TS diagnosis via genetic test.
3. Prepubertal status.
4. Naïve to growth hormone therapy or growth hormone secretagogue.
5. Exhibit impaired growth defined by at least one of the following:
1. AHV\< 6 cm/year or \<25ᵗʰ percentile over a time span of 6-18 months for children of 2 years and older.
2. Height (or length for individuals \< 2 years old) \<10ᵗʰ percentile for sex and age according to the 2000 CDC Growth Charts for the United States.
6. Bone age within normal limits for chronological age, defined as no more than 20% above or below chronological age in months or delayed for chronological age (greater than 20% below chronological age), at screening.
7. Biochemically euthyroid (including when on thyroid hormone supplementation).
8. If on hormone replacement therapies for any hormone deficiencies other than growth hormone (e.g. adrenal, thyroid), must be on adequate and stable doses for ≥4 weeks prior to and throughout Screening.
9. Fundoscopy at Screening without signs/symptoms of intracranial hypertension or proliferative retinopathy or evidence of any other retinal disease for which growth hormone therapy is contraindicated.
10. Capable of giving signed informed consent. Participants and/or parents or legal guardians of participants must sign an informed consent statement. Assent should be obtained from all participants competent to understand the protocol, per IRB requirements.
Exclusion Criteria
2. Diagnosis of diabetes mellitus.
3. 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.
4. Any known, clinically significant, congenital or acquired cardiac/cardiovascular dysfunction that might interfere with growth as determined by transthoracic echocardiogram.
5. Known history or presence of malignancy.
6. 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.
7. Hepatic transaminases (i.e., AST or ALT) above 3 times the upper limit of normal according to the central laboratory at screening.
8. Major medical conditions and/or presence of contraindication to hGH treatment.
9. Abnormal renal function.
10. 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.
11. Poorly controlled hypertension.
12. Receiving prior or concurrent treatment with any agent that might influence growth or interfere with GH secretion or action such as, but not limited to, non steroidal anabolic agents, sex steroids, etc.
13. Oral/intravenous/intramuscular corticosteroids within 90 days prior to or throughout Screening.
14. Known or suspected hypersensitivity to study intervention(s) or related products.
15. Participation in any other trial involving an investigational compound within 90 days prior to Screening or in parallel to this trial.
16. Any disease or condition that, in the judgement of the investigator, may make the individual unlikely to comply with the protocol or presents undue risk.
17. Female who is pregnant, plans to be pregnant, or is breastfeeding.
1 Year
10 Years
FEMALE
No
Sponsors
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Ascendis Pharma Endocrinology Division A/S
INDUSTRY
Responsible Party
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Locations
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Ascendis Pharma Investigational Site
Boston, Massachusetts, United States
Ascendis Pharma Investigational Site
Saint Paul, Minnesota, United States
Ascendis Pharma Investigational Site
Las Vegas, Nevada, United States
Ascendis Pharma Investigational Site
Lake Success, New York, United States
Ascendis Pharma Investigational Site
Palo Alto, California, United States
Ascendis Pharma Investigational Site
San Diego, California, United States
Ascendis Pharma Investigational Site
Aurora, Colorado, United States
Ascendis Pharma Investigational Site
Orlando, Florida, United States
Ascendis Pharma Investigational Site
St. Petersburg, Florida, United States
Ascendis Pharma Investigational Site
Atlanta, Georgia, United States
Ascendis Pharma Investigational Site
Idaho Falls, Idaho, United States
Ascendis Pharma Investigational Site
Chicago, Illinois, United States
Ascendis Pharma Investigational Site
Chapel Hill, North Carolina, United States
Ascendis Pharma Investigational Site
Cincinnati, Ohio, United States
Ascendis Pharma Investigational Site
Oklahoma City, Oklahoma, United States
Ascendis Pharma Investigational Site
Portland, Oregon, United States
Ascendis Pharma Investigational Site
El Paso, Texas, United States
Ascendis Pharma Investigational Site
Fort Worth, Texas, United States
Ascendis Pharma Investigational Site
Seattle, Washington, United States
Countries
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Other Identifiers
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ASND0034
Identifier Type: -
Identifier Source: org_study_id
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