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

ClinicalTrials.gov ID: NCT07221851

Public ClinicalTrials.gov record NCT07221851. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 19, 2026, 4:13 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07221851
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Ascendis Pharma A/S; Industry
Enrollment: 186 participants

Conditions and interventions

Conditions

Interventions

Lonapegsomatropin [SKYTROFA®] Combination Product
Somatropin Pen Injector Combination Product

Combination Product

Eligibility (public fields only)

Age range: 2 Years to 17 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 12, 2025 (Actual)
Primary completion: Feb 2028 (Estimated)
Completion: Mar 2029 (Estimated)
Last update posted: Sep 30, 2026

2025 – 2029

United States locations

U.S. sites: 23
U.S. states: 16
U.S. cities: 22

Facility	City	State	ZIP	Site status
Ascendis Pharma Investigational Site	Palo Alto	California	94304	Recruiting
Ascendis Pharma Investigational Site	Sacramento	California	95821	Recruiting
Ascendis Pharma Investigational Site	Aurora	Colorado	80045	Recruiting
Ascendis Pharma Investigational Site	Centennial	Colorado	80112	Recruiting
Ascendis Pharma Investigational Site	Wilmington	Delaware	19803	Recruiting
Ascendis Pharma Investigational Site	Washington D.C.	District of Columbia	20010	Recruiting
Ascendis Pharma Investigational Site	Orlando	Florida	32806	Recruiting
Ascendis Pharma Investigational Site	St. Petersburg	Florida	33701	Recruiting
Ascendis Pharma Investigational Site	Atlanta	Georgia	30329	Recruiting
Ascendis Pharma Investigational Site	Idaho Falls	Idaho	83404	Recruiting
Ascendis Pharma Investigational Site	New Orleans	Louisiana	70118	Recruiting
Ascendis Pharma Investigational Site	Minneapolis	Minnesota	55454	Recruiting
Ascendis Pharma Investigational Site	Saint Paul	Minnesota	55102	Recruiting
Ascendis Pharma Investigational Site	Lake Success	New York	11042	Recruiting
Ascendis Pharma Investigational Site	Cincinnati	Ohio	45229	Recruiting
Ascendis Pharma Investigational Site	Oklahoma City	Oklahoma	73104	Recruiting
Ascendis Pharma Investigational Site	Edinburg	Texas	78539	Recruiting
Ascendis Pharma Investigational Site	Fort Worth	Texas	76104	Recruiting
Ascendis Pharma Investigational Site	San Antonio	Texas	78229	Recruiting
Ascendis Pharma Investigational Site	San Antonio	Texas	78232	Recruiting
Ascendis Pharma Investigational Site	Salt Lake City	Utah	84112	Recruiting
Ascendis Pharma Investigational Site	Charlottesville	Virginia	22908	Recruiting
Ascendis Pharma Investigational Site	Seattle	Washington	98105	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07221851, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 30, 2026 · Synced Oct 19, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07221851 live on ClinicalTrials.gov.

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