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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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Turner Syndrome
  • Short Stature Homeobox Gene Mutation
  • Idiopathic Short Stature
  • Small for Gestational Age at Delivery

Interventions

COMBINATION_PRODUCT

Lonapegsomatropin [SKYTROFA®]

Subcutaneous injection once weekly

COMBINATION_PRODUCT

Somatropin Pen Injector

Subcutaneous injection once daily

Sponsors & Collaborators

  • Ascendis Pharma A/S

    lead INDUSTRY

Principal Investigators

  • Medical Director, MD · Ascendis Pharma A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-12
Primary Completion
2028-02-29
Completion
2029-03-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • France
  • Germany
  • South Korea
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07221851 on ClinicalTrials.gov