What is New InsiGHTS?
New InsiGHTS is a U.S. clinical trial to investigate the efficacy and safety of lonapegsomatropin, an investigational once-weekly injection in children having impaired growth with Turner syndrome compared to once-daily injection of somatropin. Lonapegsomatropin is not approved by any health authority for use in Turner syndrome as the safety and efficacy have not been established.
A clinical trial is a research study recruiting volunteers to evaluate a new medical intervention, which contributes to medical knowledge and understanding. To learn more about clinical trials in children, please visit the National Institutes of Health Clinical Research Trials page.
Who may participate?
Pre-pubertal children 1 to 10 years of age with Turner syndrome who have never previously had growth hormone treatment are invited to screen for trial participation.
What to expect during the clinical trial
Children with Turner syndrome are invited to screen for trial eligibility at participating clinical sites. After confirmation of eligibility, enrolled children will be randomly assigned to receive either once-weekly lonapegsomatropin or once-daily somatropin treatment. Randomization will be done by a computer system prior to first treatment, and for every four children enrolled, three will be randomly assigned to receive once-weekly treatment and one will receive once-daily treatment.
- Children, caregivers, and their doctors will know which treatment they have been randomized to receive.
- Treatment may continue for up to 2 years.
- The trial will require visits to your clinical site for assessments and tests throughout the study.
Both trial treatments are medications given with a small needle inserted under the skin.
Is there any cost to participate?
- There is no cost to participate.
- Trial-related costs for children will be covered by Ascendis Pharma for the entire duration of participation, including:
- Once-weekly and/or once-daily treatment
- Laboratory tests
- Other trial procedures
- Reimbursement and travel arrangements for children plus two caregivers may be available in accordance with guidelines from your participating site and local regulations.