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

Part of paid clinical trials in Sacramento, California.

Sponsor
Ascendis Pharma A/S
Study ID
NCT07221851
Phase
PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Lonapegsomatropin [SKYTROFA®] — COMBINATION_PRODUCT
    Subcutaneous injection once weekly
  • Somatropin Pen Injector — COMBINATION_PRODUCT
    Subcutaneous injection once daily

Study Details

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.

Key Dates

Start date
Dec 12, 2025
Status verified
May 2026
Primary completion
Feb 29, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
186 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lonapegsomatropin, once daily
    Participants will receive Lonapegsomatropin by subcutaneous injection for 2 years (104 weeks)
  • Active Comparator: somatropin, once daily
    Participants will receive somatropin by subcutaneous injection for 1 year (52 weeks) followed by lonapegsomatropin for 1 year (52 weeks)

Primary Outcome Measure

Annualized Height Velocity (AHV) (cm/year) [ Time Frame: 52 Weeks ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Ascendis Pharma Investigational SiteSacramentoCalifornia95821-
Ascendis Pharma Investigational SiteCentennialColorado80112-
Ascendis Pharma Investigational SiteOrlandoFlorida32806-
Ascendis Pharma Investigational SiteAtlantaGeorgia30329-
Ascendis Pharma Investigational SiteIdaho FallsIdaho83404-
Ascendis Pharma Investigational SiteNew OrleansLouisiana70118-
Ascendis Pharma Investigational SiteSaint PaulMinnesota55102-
Ascendis Pharma Investigational SiteOklahoma CityOklahoma73104-
Ascendis Pharma Investigational SiteSan AntonioTexas78229-

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