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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Once-weekly subcutaneous injection of Lonapegsomatropin
Once-daily subcutaneous injection of Somatropin
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
Boston, Massachusetts, United States
Ascendis Pharma Investigational Site
Saint Paul, Minnesota, United States
...and 9 more locations
Annualized Height Velocity (AHV) (cm/year)
Calculated based on the difference between the AHV at 6 months and baseline
Time frame: 26 weeks
Annualized Height Velocity (AHV) (cm/year)
Calculated based on the difference between the AHVs at 12, 24, 36 and 42 months and baseline
Time frame: 52 weeks, 104 weeks, 156 weeks and 182 weeks
Change from baseline in height standard deviation score (SDS)
Calculated based on the difference between the heights SDS at 6, 12, 24, 36 and 42 months and baseline
Time frame: 26 weeks, 52 weeks, 104 weeks, 156 weeks and 182 weeks
Change from baseline in Bone age (calculated years)
Annual change in bone age measurements as per Gruelich-Pyle method
Time frame: 52 weeks, 104 weeks and 156 weeks
Change from baseline in ratio of bone age/chronological age
Calculated as a ratio
Time frame: 52 weeks, 104 weeks and 156 weeks
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