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 (NCT07221851)
A Pivotal, Parallel-Arm, Phase 3, Open-Label, Active-controlled, Global, Multicenter, Randomized Basket Trial Investigating the Efficacy and Safety of Once-weekly Lonapegsomatropin Compared to Daily Somatropin in Prepubertal Children and Adolescents With Growth Failure or Short Stature Due to Growth Hormone Sufficient Disorders - Turner Syndrome, SHOX Deficiency, Small for Gestational Age, and Idiopathic Short Stature
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Ascendis Pharma Investigational Site — Palo Alto, California
Age range: 2 Years to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (40 Sites)
Showing the first 25 of 40 sites.
- Ascendis Pharma Investigational Site — Palo Alto, California
- Ascendis Pharma Investigational Site — Sacramento, California
- Ascendis Pharma Investigational Site — Aurora, Colorado
- Ascendis Pharma Investigational Site — Centennial, Colorado
- Ascendis Pharma Investigational Site — Wilmington, Delaware
- Ascendis Pharma Investigational Site — Orlando, Florida
- Ascendis Pharma Investigational Site — St. Petersburg, Florida
- Ascendis Pharma Investigational Site — Atlanta, Georgia
- Ascendis Pharma Investigational Site — Idaho Falls, Idaho
- Ascendis Pharma Investigational Site — New Orleans, Louisiana
- Ascendis Pharma Investigational Site — Minneapolis, Minnesota
- Ascendis Pharma Investigational Site — Saint Paul, Minnesota
- Ascendis Pharma Investigational Site — Lake Success, New York
- Ascendis Pharma Investigational Site — Oklahoma City, Oklahoma
- Ascendis Pharma Investigational Site — Edinburg, Texas
- Ascendis Pharma Investigational Site — Fort Worth, Texas
- Ascendis Pharma Investigational Site — San Antonio, Texas
- Ascendis Pharma Investigational Site — San Antonio, Texas
- Ascendis Pharma Investigational Site — Seattle, Washington
- Ascendis PharmaInvestigational Site — Le Kremlin-Bicêtre,
- Ascendis Pharma Investigational Site — Montpellier,
- Ascendis Pharma Investigational Site — Paris,
- Ascendis Pharma Investigational Site — Toulouse,
- Ascendis Pharma Investigational Site — Düsseldorf,
- Ascendis Pharma Investigational Site — Hanover,
📞 Contact the Study Coordinator
Phone: (456) 116-1658
Email: asnd_registryinquiries@ascendispharma.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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 § 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.
More studies in Turner Syndrome
- A Trial to Investigate Different Doses of Lonapegsomatropin Compared to Somatropin in Individuals With Turner Syndrome — Palo Alto, California
- Pre-pubertal Low Dose Transdermal Estradiol in Turner Syndrome — Washington D.C., District of Columbia
- UTHealth Turner Syndrome Research Registry — Houston, Texas
- Vosoritide for Short Stature in Turner Syndrome — Washington D.C., District of Columbia
- Inspiring New Science In Guiding Healthcare in Turner Syndrome Registry — Aurora, Colorado
Explore by condition: All Turner Syndrome clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.