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Children gardening

A Global Clinical Trial for Children and Adolescents with Turner Syndrome (TS), SHOX Deficiency (SHOX-D), Small for Gestational Age (SGA) and Idiopathic Short Stature (ISS)

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What is HighLiGHts?

This clinical trial will study how safe and effective a new medicine called lonapegsomatropin* is for children and adolescents with certain growth conditions. These include TS, SHOX-D, SGA, or ISS. The new medicine is a once-a-week injection and will be compared to somatropin, a once-a-day injection that is already approved for some uses.

* Lonapegsomatropin is still being studied and has not yet been approved for use in children and adolescents with Turner Syndrome, SHOX Deficiency, Small for Gestational Age, and Idiopathic Short Stature

What happens in this trial?

Those who may qualify will be screened at a local clinic. If eligible, they will be randomly assigned (by a computer) to receive either: once-a-week lonapegsomatropin, or once-a-day somatropin. Both medicines are given with a small needle under the skin.

  • Families and doctors will know which treatment is being given.
  • Treatment may last up to 2 years.
  • Children will need to visit the clinic for check-ups and tests during the study.

Who can join?

Children ages 2 to under 18 who:

  • Have Turner Syndrome, SHOX Deficiency, SGA, or ISS
  • Have not had growth hormone treatment before
  • Are not yet in puberty

Does it cost anything to join the trial?

No, there is no cost to join the trial. Ascendis Pharma will pay for all trial-related care during the study, including:

  • The once-a-week and/or once-a-day medicine
  • Lab tests
  • Other trial procedures

You may also get help with travel costs for your child and up to two caregivers, depending on the rules at your clinic and local laws.

How do I participate?

Study locations in France, Italy, Germany, Romania, Spain, South Korea, and the United States will be participating in the trial.

For a list of participating study locations and to learn more about the HighLiGHts clinical trial, please see clinicaltrials.gov (NCT07221851), or contact your child's doctor.