Somapacitan vs. Norditropin® for Small for Gestational Age (SGA) Children
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines two treatments for children born small who remain smaller than their peers. It compares somapacitan, a new medicine administered weekly, with Norditropin® (a growth hormone treatment), an existing daily treatment. The goal is to determine which treatment better promotes growth in children. This trial targets pre-pubertal children with significantly shorter height than average and no prior growth hormone treatment. Participants will know which treatment they receive, and the study will last five years. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, contributing to important early findings.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it excludes children who need certain treatments that affect growth, like some ADHD medications or high doses of inhaled steroids. It's best to discuss your specific medications with the study doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that somapacitan, administered once a week, is generally safe for children who are smaller than average for their age. Studies indicate that somapacitan is well-tolerated over extended periods, with reports up to four years showing that children have managed the treatment well, without major safety concerns. Somapacitan appears to be as safe as the daily treatment option, Norditropin®.
Norditropin® is already approved for use, and its safety is well-established. It has treated growth issues in children for many years, and most children handle it without serious problems.
Both treatments are given as injections, but somapacitan is weekly, while Norditropin® is daily. This difference might affect ease of use, but both have been shown to be safe options for treating children who are smaller than average for their age.12345Why are researchers excited about this trial's treatments?
Researchers are excited about somapacitan for treating Small for Gestational Age (SGA) children because it offers a potentially more convenient dosing schedule compared to existing treatments like Norditropin®. While Norditropin® requires daily injections, somapacitan is designed for once-weekly administration, which could improve adherence and quality of life for patients and families. This longer-acting growth hormone could maintain stable hormone levels with fewer injections, making it an attractive alternative to current options.
What evidence suggests that this trial's treatments could be effective for children born small for gestational age?
Research has shown that somapacitan helps children born smaller than usual for their age grow better. In one study, children who took somapacitan grew steadily over a year, with higher doses leading to more growth. Another study found that children continued to grow taller over four years, indicating long-term benefits. In this trial, some participants will receive somapacitan, which has proven to be as effective, or even better, than daily growth hormone treatments like Norditropin® in promoting growth. Norditropin®, which other participants in this trial will receive, is already an approved and effective treatment for growth in children born small for their age.12467
Who Is on the Research Team?
Clinical Reporting Anchor and Disclosure 1452
Principal Investigator
Novo Nordisk A/S
Are You a Good Fit for This Trial?
This trial is for pre-pubertal boys aged 2.5-11 years and girls aged 2.5-10 years who were born small, have stayed small, and haven't had growth hormone or IGF-I treatment. Kids with hormonal deficiencies, significant health issues affecting growth, recent steroid treatments, high-dose inhaled steroids, or other growth-affecting drugs can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Somapacitan once a week or Norditropin® once a day for 26 weeks
Extension Period I
Continuation of the same treatment for an additional 26 weeks
Extension Period II
Participants switch to Somapacitan with dosage determined based on main phase data
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Norditropin®
- somapacitan
Norditropin® is already approved in United States, European Union for the following indications:
- Pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH)
- Short stature associated with Noonan syndrome
- Short stature associated with Turner syndrome
- Short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years
- Idiopathic Short Stature (ISS)
- Growth failure due to Prader-Willi syndrome (PWS)
- Replacement of endogenous GH in adults with growth hormone deficiency (GHD)
- Pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH)
- Short stature associated with Noonan syndrome
- Short stature associated with Turner syndrome
- Short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years
- Idiopathic Short Stature (ISS)
- Growth failure due to Prader-Willi syndrome (PWS)
- Replacement of endogenous GH in adults with growth hormone deficiency (GHD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novo Nordisk A/S
Lead Sponsor
Lars Fruergaard Jørgensen
Novo Nordisk A/S
Chief Executive Officer since 2017
MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark
Martin Holst Lange
Novo Nordisk A/S
Chief Medical Officer since 2021
MD from University of Copenhagen