Somapacitan vs. Norditropin® for Small for Gestational Age (SGA) Children

Recruiting in Palo Alto (17 mi)

+142 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Novo Nordisk A/S

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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

I am a boy aged 2.5 to 11 years with small testes.

I am a girl aged 2.5-10, born small for my age, with slow growth and no hormone treatments.

Exclusion Criteria

You have a medical condition that could affect your growth or make it difficult to measure your height accurately.

I have had cancer before, including brain tumors.

I am not taking medications like methylphenidate that affect growth.

+4 more

Participant Groups

The study compares somapacitan (a new medicine given weekly) to Norditropin® (an existing daily treatment) in children born small for gestational age. It's a randomized trial where both doctors and participants know which treatment is received over the course of one year with follow-up.

5Treatment groups

Experimental Treatment

Active Control

Group I: Somapacitan 0.24 mg/kg/weekExperimental Treatment1 Intervention

Same treatment in main period (26 weeks) and extension period I (26 weeks). Dosage of Somapacitan during extension period II will be determined based on the data from main phase.

Group II: Somapacitan 0.20 mg/kg/weekExperimental Treatment1 Intervention

Same treatment in main period (26 weeks) and extension period I (26 weeks). Dosage of Somapacitan during extension period II will be determined based on the data from main phase.

Group III: Somapacitan 0.16 mg/kg/weekExperimental Treatment1 Intervention

Same treatment in main period (26 weeks) and extension period I (26 weeks). Dosage of Somapacitan during extension period II will be determined based on the data from main phase.

Group IV: Norditropin® 0.035 mg/kg/dayActive Control1 Intervention

Same treatment in main period (26 weeks) and extension period I (26 weeks). Participants will switch to Somapacitan during extension period II. Dosage of Somapacitan during extension period II will be determined based on the data from main phase.

Group V: Norditropin® 0.067 mg/kg/dayActive Control1 Intervention

Norditropin® is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Norditropin for:

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)

🇪🇺 Approved in European Union as Norditropin for:

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)