A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
Running, not enrolling · Phase 2
Conditions studied: Short Stature Children Born Small for Gestational Age (SGA)
In brief
The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Participants will either get somapacitan or Norditropin® - which treatment is decided by chance. Both participants and the study doctor will know which treatment the participants get. The study will last for 5 years. Participants will take either an injection once every week or once every day.
Key facts
- Study ID
- NCT03878446
- Run by
- Novo Nordisk A/S
- People needed
- 62
- Starts
- 2019-07-04
- Expected to finish
- 2026-12-23
- Last updated by the study team
- 2026-06-10
Who can join
Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Pre-pubertal children, boys:
- age between 2.5 and 11.0 years at screening.
- testes volume below 4 ml.
- Pre-pubertal children, girls:
- age between 2.5 and 10.0 years at screening.
- Tanner stage 1 for breast development (no palpable glandular breast tissue).
- Born small for gestational age (birth length and/or weight below -2 standard deviation scores) (according to national standards).
- Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and gender at screening according to the standards of Centers for Disease Control and Prevention at screening.
- Impaired height velocity defined as annualized height velocity below the 50th 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.
- No prior exposure to growth hormone therapy or Insulin-like Growth Factor-I (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.
- Children with hormonal deficiencies including suspected or confirmed growth hormone deficiency according to local practise.
- 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.
- 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.
- Diagnosis of attention deficit hyperactivity disorder.
- Prior history or presence of malignancy including intracranial tumours.
Where it is running
- Children's Hosp Of Orange — Orange, California, United States
- St. Luke's Children's Endo — Boise, Idaho, United States
- Univ of Minnesota M.C.H. — Minneapolis, Minnesota, United States
- Children's Minnesota — Saint Paul, Minnesota, United States
- Goryeb Children's Hospital — Morristown, New Jersey, United States
- Rutgers-Rwjms — New Brunswick, New Jersey, United States
- NYU Langone Hospital-LI — Garden City, New York, United States
- NYU Langone Hospital-LI — Mineola, New York, United States
- Icahn Sch of Med-Mt Sinai Hosp — New York, New York, United States
- CCHMC_Cinc — Cincinnati, Ohio, United States
- Univ Oklahoma Sci Ctr OK City — Oklahoma City, Oklahoma, United States
- Cook Children's Hospital-Hematology-Oncology — Fort Worth, Texas, United States
- MultiCare Inst for Res & Innov — Tacoma, Washington, United States
- CHU Bab El Oued Pediatrics Dept — Algiers, Algeria
- Endo and Diab Dept El Oued — Algiers, Algeria
- endocrino-diabetology department, Hospital IBN BADIS. — Constantine, Algeria
- Kepler Universitätsklinikum GmbH - Med Campus IV (vorm.LFKK) — Linz, Upper Austria, Austria
- Med. Univ. Graz -Klinische Abteilung f. Allgemeine Pädiatrie — Graz, Austria
- LKH Salzburg- Univ. Klinik f. Kinder- und Jugendheilkunde — Salzburg, Austria
- LKH St. Poelten, Kinder-und Jugendheilkunde — Sankt Pölten, Austria
- Salzkammergut-Klinikum Vöcklabruck — Vöcklabruck, Austria
- Stollery Children's Hospital — Edmonton, Alberta, Canada
- Rigshospitalet Klinik for Vækst og Reproduktion Afsnit 5064 — Copenhagen Ø, Denmark
- Tallinn Children's Hospital — Tallinn, Estonia
- Univ of AL at Birmingham_BRM — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.