A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow
- Conditions
- SGA, Turner Syndrome, Noonan Syndrome, ISS
- Interventions
- Registration Number
- NCT05330325
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries. The study will last for upto 5.5 years. The participants will either get somapacitan once a week up to 5.5 years or Norditropin® once a day for 1 year followed by somapacitan once a week for up to 4.5 years. Which treatment the participants get is decided by chance.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 399
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Somapacitan Somapacitan Participants will receive Somapacitan for 273 weeks Norditropin® Norditropin® Participants will receive Norditropin® for 52 weeks (main treatment period) and Somapacitan for 221 weeks (extension period)
- Primary Outcome Measures
Name Time Method Height velocity reported separately for small for gestational age (SGA), Turner syndrome (TS), Noonan syndrome (NS) and idiopathic short stature (ISS) From baseline (week 0) to visit 7 (week 52) Measured in centimeter per year (cm/year)
- Secondary Outcome Measures
Name Time Method Change in bone age reported separately for SGA, TS and NS From baseline (week 0) to visit 7 (week 52) Measured in ratio
Change in insulin-like growth factor 1 (IGF-1) SDS reported separately for SGA, TS, NA and ISS From baseline (week 0) to visit 7 (week 52). Measured in score. Positive score indicates that the value is closer to or above the reference population compared to baseline.
Change in glycated haemoglobin (HbA1c) reported separately for SGA, TS, NS and ISS From screening (visit 1) to visit 15 (week 156) Measured in percentage of HbA1c
Change in Height Velocity SDS reported separately for SGA, TS, NS and ISS From baseline (week 0) to visit 7 (week 52) Measured in score. Positive score indicates that the value is closer to or above the reference population compared to baseline.
Change in fasting plasma glucose reported separately for SGA, TS, NS and ISS From screening (visit 1) to visit 15 (week 156) Measured in mmol/L
Change in homeostatic model assessment-B (HOMA-B) reported separately for SGA, TS, NS and ISS From screening (visit 1) to visit 15 (week 156) Measured in %
Change in homeostatic model assessment of insulin resistance (HOMA-IR) reported separately for SGA, TS, NS and ISS From screening (visit 1) to visit 15 (week 156) Measured in %
Change in Height standard deviation scores (SDS) reported separately for SGA, TS, NS and ISS From baseline (week 0) to visit 7 (week 52) Measured in score. Positive score indicates that the value is closer to or above the reference population compared to baseline.
Change in bone age for ISS From screening (visit 1) to visit 7 (week 52) Measured in ratio
Change in insulin-like growth factor binding protein-3 (IGFBP-3) SDS reported separately for SGA, TS, NA and ISS From baseline (week 0) to visit 7 (week 52). Measured in score. Positive score indicates that the value is closer to or above the reference population compared to baseline.
Change in homeostatic model assessment of insulin resistance (HOMAIR) reported separately for SGA, TS, NS and ISS From screening (visit 1) to visit 7 (week 52) Measured in %
Weekly average somapacitan concentration (Cavg) based on population PK analysis From visit 3 (week 4) to visit 7 (week 52) Measured in nanograms per milliliter (ng/mL)
Trial Locations
- Locations (156)
Children's Hospital Los Angeles - Endocrinology
🇺🇸Los Angeles, California, United States
Sutter Valley Med Fdt Ped Endo
🇺🇸Sacramento, California, United States
Rady Childrens Hosp San Diego
🇺🇸San Diego, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Ped Endo Assoc PC-G.V
🇺🇸Greenwood Village, Colorado, United States
Nemours/AI duPont Hosp-Chld
🇺🇸Wilmington, Delaware, United States
Childrens National Medical Ctr
🇺🇸Washington, District of Columbia, United States
Nemours Chld Clnc Jacksonville
🇺🇸Jacksonville, Florida, United States
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
St. Luke's Children's Endo
🇺🇸Boise, Idaho, United States
Scroll for more (146 remaining)Children's Hospital Los Angeles - Endocrinology🇺🇸Los Angeles, California, United States