A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow

Running, not enrolling · Phase 3

Conditions studied: SGA, Turner Syndrome, Noonan Syndrome, ISS

In brief

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.

Key facts

Study ID

NCT05330325

Run by

Novo Nordisk A/S

People needed

412

Starts

2022-08-10

Expected to finish

2027-10-29

Last updated by the study team

2026-06-12

Who can join

Age: 2 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent of parent or legally acceptable representative of participant and child assent, as age appropriate must be obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
• No prior exposure to growth promoting therapy, including but not limited to growth hormone, IGF-I and ghrelin analogues.
• Applicable to children with SGA:
• Born small for gestational age (birth length below -2 SDS OR birth weight below -2 SDS OR both) (according to national standards).
• Prepubertal children:
• Boys:
• Age above or equal to 2 years and 26 weeks and below 11.0 years at screening.
• Testis volume below 4 mL
• Girls:
• Age above or equal to 2 years and 26 weeks and below 10.0 years at screening.
• Tanner stage 1 for breast development: No palpable glandular breast tissue)
• Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention.
• Impaired height velocity defined as annualized height velocity below the 50th percentile for chronological age and sex according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening.
• Body Mass Index below the 95th percentile according to Centers for Disease Control and Prevention, Body Mass Index-for-age growth charts.
• Applicable to girls with TS:
• Confirmed diagnosis of TS by 30-cell (or more) lymphocyte chromosomal analysis.*
• Prepubertal girls:
• Age above or equal to 2 years and 26 weeks and below 10.0 years at screening.
• Tanner stage 1 for breast development: No palpable glandular breast tissue)
• Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention.
• Historical height measured 6-18 months prior to screening.
• Thyroid hormone replacement therapy should be adequate and stable for at least 90 days prior to randomization, if applicable.
• Applicable to children with NS:
• Clinical diagnosis of NS according to van der Burgt score list
• Prepubertal children:

You may not qualify if…

• Known or suspected hypersensitivity to study intervention(s) or related products.
• Previous randomization into same sub-study in this study.
• Receipt of any investigational medicinal product within 3 months before screening or participation in another clinical study at the time of randomization.
• Children with suspected or confirmed growth hormone deficiency according to local practice.
• laboratory of
• fasting plasma glucose above or equal to 126 mg/dL (7.0 mmol/L) or
• HbA1c above or equal to 6.5%.
• Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening.
• Children requiring inhaled glucocorticoid therapy at a dose greater than 400 µg/day of inhaled budesonide or equivalent (i.e., 250 µg/day for fluticasone propionate) for longer than 4 consecutive weeks within the last 12 months prior to screening.
• Concomitant administration of other treatments that may have an effect on growth, e.g., but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder (ADHD).
• Diagnosis of attention deficit hyperactivity disorder (ADHD).
• History or known presence of any malignancy, intracranial tumour, or intracranial cyst.
• History or known presence of active Hepatitis B or Hepatitis C (exceptions to this exclusion criterion is the presence of antibodies due to vaccination against Hepatitis B).
• Any disorder, which in the investigator's opinion, might jeopardize participant's safety or compliance with the protocol.
• The participant or the parent/legally acceptable representative is likely to be non-compliant in respect to study conduct, as judged by the investigator.
• Current treatment with sex hormones or aromatase inhibitors.
• Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements, such as, but not limited to:
• Known family history of skeletal dysplasia.
• Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants.
• Any other disorder/condition that can cause short stature such as, but not limited to, psychosocial deprivation, nutritional disorders, chronic systemic illness and chronic renal disease.
• Applicable to children with SGA:
• TS (including mosaicism).
• NS.
• Hormonal deficiencies.
• Children who are small due to malnutrition defined as -2 standard deviations according to standards. 0¬-5 years: weight for height on World Health Organization Multicentre Growth Reference Study 2006. Above 5 years: World Health Organization 2007 Body Mass Index.

Where it is running

• 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
• Rocky Mt Ped and Endo — Centennial, 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 D.C., 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
• Rocky Mt Clin Res, LLC — Idaho Falls, Idaho, United States
• Riley Hosp for Child-Indiana U — Indianapolis, Indiana, United States
• University OF Iowa — Iowa City, Iowa, United States
• UMass Medical School — Worcester, Massachusetts, United States
• Univ of Minnesota M.C.H. — Minneapolis, Minnesota, United States
• Children's Minnesota — Saint Paul, Minnesota, United States
• Univ of Mississippi Med Ctr — Jackson, Mississippi, United States
• The Children's Mercy Hospital — Kansas City, Missouri, United States
• Goryeb Children's Hospital — Morristown, New Jersey, United States
• UBMD Peds-Div of Endo/Diabetes — Buffalo, New York, United States
• NYU Langone Hospital-LI — Garden City, New York, United States
• NYU Langone Hospital-LI — Mineola, New York, United States
• WakeMed Childn Endo-Dbt_Raleig — Raleigh, North Carolina, United States
• Univ of AL at Birmingham_BRM — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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