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A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day

NCT03878446 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-12-23

Study results available
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Summary

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.

Conditions

  • Short Stature Children Born Small for Gestational Age (SGA)

Interventions

DRUG

Somapacitan

Somapacitan injected under the skin once a week.

DRUG

Norditropin®

Norditropin® injected under the skin once a day.

Sponsors & Collaborators

Principal Investigators

  • Clinical Reporting Anchor and Disclosure 1452 · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-04
Primary Completion
2021-05-05
Completion
2026-12-23
FDA Drug
Yes

Countries

  • United States
  • Algeria
  • Austria
  • Canada
  • Denmark
  • Estonia
  • France
  • Hungary
  • India
  • Ireland
  • Israel
  • Italy
  • Japan
  • Latvia
  • Norway
  • Poland
  • Russia
  • Serbia
  • Spain
  • Switzerland
  • Thailand
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03878446 on ClinicalTrials.gov