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

NCT05330325 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 412

Last updated 2026-04-24

No results posted yet for this study

Summary

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.

Conditions

  • SGA, Turner Syndrome, Noonan Syndrome, ISS

Interventions

DRUG

Somapacitan

Somapacitan will be administered subcutaneously (s.c.) once weekly using PDS290 pen-injector.

DRUG

Norditropin®

Norditropin® will be administered s.c. once daily using FlexPro® pen-injector.

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency dept. 2834 · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-08-10
Primary Completion
2024-08-05
Completion
2027-10-29
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Croatia
  • Finland
  • France
  • Germany
  • Greece
  • India
  • Ireland
  • Israel
  • Italy
  • Japan
  • Latvia
  • Lithuania
  • Malaysia
  • Mexico
  • Netherlands
  • Poland
  • Portugal
  • Saudi Arabia
  • Serbia
  • Slovenia
  • South Africa
  • South Korea
  • Spain
  • Switzerland
  • Thailand
  • 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 NCT05330325 on ClinicalTrials.gov