A Trial to Investigate Different Doses of Lonapegsomatropin Compared to Somatropin in Individuals… (NCT05690386) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Trial to Investigate Different Doses of Lonapegsomatropin Compared to Somatropin in Individuals With Turner Syndrome
United States48 participantsStarted 2023-02-15
Plain-language summary
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 participate
Age range1 Year – 10 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age between 1 and 10 years, inclusive.
✓. TS diagnosis via genetic test.
✓. Prepubertal status.
✓. Naïve to growth hormone therapy or growth hormone secretagogue.
✓. Exhibit impaired growth defined by at least one of the following:
✓. AHV\< 6 cm/year or \<25ᵗʰ percentile over a time span of 6-18 months for children of 2 years and older.
✓. 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.
✓. 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.
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.