A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)

Completed · Phase 3

Conditions studied: Growth Hormone Deficiency in Children

In brief

The study compares 2 medicines for children who do not have enough hormone to grow: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Researchers will test to see how well somapacitan works. The study will also test if somapacitan is safe. Participants will either get somapacitan or Norditropin® - which treatment participants get, is decided by chance. Both participants and the study doctor will know which treatment participants get. The study will last for 4 years. Participants will attend 19 clinic visits and have 1 phone call with the study doctor.

Key facts

Study ID

NCT03811535

Run by

Novo Nordisk A/S

People needed

200

Starts

2019-05-20

Expected to finish

2025-09-30

Last updated by the study team

2026-05-22

Who can join

Age: any, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prepubertal children: a) Boys: Age more than or equal to 2 years and 26 weeks and less than 11.0 years at screening. Testis volume less than 4 ml. b) Girls: Age more than or equal to 2 years and 26 weeks and less than 10.0 years at screening. Tanner stage 1 for breast development (no palpable glandular breast tissue)
• Confirmed diagnosis of growth hormone deficiency determined by two different growth hormone stimulation tests performed within 12 months prior to randomisation, defined as a peak growth hormone level of less than or equal to 10.0 ng/ml using the World Health Organisation (WHO) International Somatropin 98/574 standard
• Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and gender at screening according to the standards of Center for Disease Control and Prevention
• Impaired height velocity, defined as annualised height velocity below the 25th percentile for chronological age and gender according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening
• Insulin-like Growth Factor-I (IGF-I) less than -1.0 SDS at screening, compared to age and gender normalized range measured at central laboratory
• No prior exposure to growth hormone therapy or IGF-I treatment

You may not qualify if…

• Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements
• 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 of greater than 400 μg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening
• Diagnosis of attention deficit hyperactivity disorder
• 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
• Prior history or presence of malignancy including intracranial tumours

Where it is running

• Children's Hospital Los Angeles - Endocrinology — Los Angeles, California, United States
• Valley Children's Hospital — Madera, California, United States
• Children's Hosp Of Orange — Orange, California, United States
• Sutter Valley Med Fdt Ped Endo — Sacramento, California, United States
• Rocky Mt Ped and Endo — Centennial, Colorado, United States
• Ped Endo Assoc PC-G.V — Greenwood Village, Colorado, United States
• Yale-New Haven Hospital — New Haven, Connecticut, United States
• A.I. duPont Hospital for Children/Nemours — Wilmington, Delaware, United States
• Pediatric Endocrine & Wellness Center — Aventura, Florida, United States
• Van Meter Pediatric Endo PC — Atlanta, Georgia, United States
• Riley Hospital For Children — Indianapolis, Indiana, United States
• University OF Iowa — Iowa City, Iowa, United States
• Univ of Minnesota M.C.H. — Minneapolis, Minnesota, United States
• Children's Minnesota — Saint Paul, Minnesota, United States
• Children's Mercy Clinics — Kansas City, Missouri, United States
• The Docs — Las Vegas, Nevada, 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 — Mineola, New York, United States
• WakeMed Childn Endo-Dbt_Raleig — Raleigh, North Carolina, United States
• CCHMC_Cinc — Cincinnati, Ohio, United States
• Univ Oklahoma Sci Ctr OK City — Oklahoma City, Oklahoma, United States
• UPMC Child Hosp-Pittsburgh — Pittsburgh, Pennsylvania, United States
• Dell Children's Medical Center — Austin, Texas, United States
• Univ of AL at Birmingham_BRM — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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