Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Start Date
12/12/2025
Completion Date
3/1/2029
Summary
This basket trial will enroll prepubertal children and adolescents with clinically diagnosed and genetically confirmed (if applicable) TS, SHOX-D, SGA, or ISS between ages of ≥2 and \<18 years with open growth plates. The purpose of the study is to see how well treatment with once-weekly lonapegsomatropin works compared to treatment with daily somatropin. Approximately 186 participants will be distributed equally (1:1), to receive either lonapegsomatropin for 2 years or somatropin for 1 year followed by lonapegsomatropin for 1 year. This trial will be conducted in the United States, France, Germany, Italy, Romania, Spain and South Korea.
Eligibility Criteria
Age Range: 2 years to 17 years
Interventions
Lonapegsomatropin [SKYTROFA®]
Somatropin Pen Injector
Conditions
Locations
Ascendis Pharma Investigational Site
Palo Alto, California 94304
United States
Ascendis Pharma Investigational Site
Sacramento, California 95821
United States
Ascendis Pharma Investigational Site
Aurora, Colorado 80045
United States
Ascendis Pharma Investigational Site
Centennial, Colorado 80112
United States
Ascendis Pharma Investigational Site
Wilmington, Delaware 19803
United States
Ascendis Pharma Investigational Site
Washington D.C., District of Columbia 20010
United States
Ascendis Pharma Investigational Site
Orlando, Florida 32806
United States
Ascendis Pharma Investigational Site
St. Petersburg, Florida 33701
United States
Ascendis Pharma Investigational Site
Atlanta, Georgia 30329
United States
Ascendis Pharma Investigational Site
Idaho Falls, Idaho 83404
United States
Ascendis Pharma Investigational Site
New Orleans, Louisiana 70118
United States
Ascendis Pharma Investigational Site
Minneapolis, Minnesota 55454
United States
Ascendis Pharma Investigational Site
Saint Paul, Minnesota 55102
United States
Ascendis Pharma Investigational Site
Lake Success, New York 11042
United States
Ascendis Pharma Investigational Site
Cincinnati, Ohio 45229
United States
Ascendis Pharma Investigational Site
Oklahoma City, Oklahoma 73104
United States
Ascendis Pharma Investigational Site
Edinburg, Texas 78539
United States
Ascendis Pharma Investigational Site
Fort Worth, Texas 76104
United States
Ascendis Pharma Investigational Site
San Antonio, Texas 78229
United States
Ascendis Pharma Investigational Site
San Antonio, Texas 78232
United States
Ascendis Pharma Investigational Site
Salt Lake City, Utah 84112
United States
Ascendis Pharma Investigational Site
Charlottesville, Virginia 22908
United States
Ascendis Pharma Investigational Site
Seattle, Washington 98105
United States
Ascendis Pharma Investigational Site
Angers, 49933
France
Ascendis PharmaInvestigational Site
Le Kremlin-Bicêtre, 94270
France
Ascendis Pharma Investigational Site
Montpellier, 34090
France
Ascendis Pharma Investigational Site
Paris, 75012
France
Ascendis Pharma Investigational Site
Toulouse, 31300
France
Ascendis Pharma Investigational Site
Cologne, 50931
Germany
Ascendis Pharma Investigational Site
Düsseldorf, 40225
Germany
Ascendis Pharma Investigational Site
Hanover, 30173
Germany
Ascendis Pharma Investigational Site
Tübingen, 72076
Germany
Ascendis Pharma Investigational Site
Florence, 50139
Italy
Ascendis Pharma Investigational Site
Genova, 16147
Italy
Ascendis Pharma Investigational Site
Naples, 80131
Italy
Ascendis Pharma Investigational Site
Naples, 80138
Italy
Ascendis Pharma Investigational Site
Trieste, 34123
Italy
Ascendis Pharma Investigational Site
Iași, 700106
Romania
Ascendis Pharma Investigational Site
Târgu Mureş, 540136
Romania
Ascendis Pharma Investigational Site
Sejong, 30099
South Korea
Ascendis Pharma Investigational Site
Seongnam, 13620
South Korea
Ascendis Pharma Investigational Site
Seoul, 03722
South Korea
Ascendis Pharma Investigational Site
Seoul, 05278
South Korea
Ascendis Pharma Investigational Site
Seoul, 05505
South Korea
Ascendis Pharma Investigational Site
Seoul, 06273
South Korea
Ascendis Pharma Investigational Site
Suwon, 16499
South Korea
Ascendis Pharma Investigational Site
Barcelona, 08035
Spain
Ascendis Pharma Investigational Site
Barcelona, 8950
Spain
Ascendis Pharma Investigational Site
Madrid, 28046
Spain
Ascendis Pharma Investigational Site
Málaga, 29011
Spain
Ascendis Pharma Investigational Site
Zaragoza, 50009
Spain