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NCT05723835 · ClinicalTrials.gov registry record · Phase 3

A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9

A Phase 3 study of Turner Syndrome and Noonan Syndrome, sponsored by Novo Nordisk A/S.

Active
Registry status
Phase 3
Development phase
47
Enrollment target
17
Study locations

NCT05723835 is a Phase 3 study of Turner Syndrome and Noonan Syndrome that is active but no longer recruiting, run by Novo Nordisk A/S. The registered enrollment target is 47 participants, below the 516-participant average among 14 other Turner Syndrome trials with a reported enrollment target (91% lower). The trial reports 17 study locations across 10 states.

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The verdict

NCT05723835, a Phase 3 study of Turner Syndrome and Noonan Syndrome, is active but no longer recruiting, sponsored by Novo Nordisk A/S.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
47 participants
Enrollment target
17
Study locations

Study Summary

The purpose of this study is to find out if somapacitan is safe and how well somapacitan works in children either born small for gestational age or with Turner syndrome, Noonan syndrome or idiopathic short stature. Somapacitan is a new growth hormone medicine for treatment of low level of growth hormone. The study will last for about 3 years. During the study, the participants will be treated with somapacitan once a week. Somapacitan can be injected anytime during the day. The study doctor or nurse will show how to inject somapacitan, so that the participant knows how to do it at home.

Interventions

  • DRUG Somapacitan

Study Locations (17)

Other

  • Erasmus MC - Rotterdam
  • UCK, Klinika Pediatrii, Diabetologii i Endokrynologii, - Gdansk
  • Instytut Centrum Zdrowia Matki Polki - Lodz
  • Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie - Rzeszów
  • SPSK nr 1 im. prof.S.Szyszko w Zabrzu - Zabrze
  • Asan Medical Center - Seoul
  • Pusan National University Yangsan Hospital - Yangsan
  • Hospital Vall d'Hebron - Barcelona

Alabama

  • Univ of AL at Birmingham_BRM - Birmingham

California

  • Sutter Valley Med Fdt Ped Endo - Sacramento

Colorado

  • Rocky Mt Ped and Endo - Centennial

District of Columbia

  • Childrens National Medical Ctr - Washington D.C.

Idaho

  • Rocky Mt Clin Res, LLC - Idaho Falls

Minnesota

  • Children's Minnesota - Saint Paul

Kuala Lumpur

  • University Malaya Medical Centre - Lembah Pantai

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2023-02-01
Est. Completion 2027-10-29
Phase Phase 3

Sponsor

Novo Nordisk A/S

431 total trials

What the Registry Record Tells You About NCT05723835

The ClinicalTrials.gov registry entry for NCT05723835 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 516-participant average among 14 other Turner Syndrome trials with a reported enrollment target (91% lower). The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Turner Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Somapacitan is the first listed.

NCT05723835 reports 17 study locations spanning 10 distinct geographic areas - top geographies include Other, Alabama, California.

Frequently Asked Questions

What is clinical trial NCT05723835 about?

NCT05723835 is a clinical study titled "A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9". The purpose of this study is to find out if somapacitan is safe and how well somapacitan works in children either born small for gestational age or with Turner syndrome, Noonan syndrome or idiopathic short stature. Somapacitan is a new growth hormone medicine for treatment of low level of growth hor...

What is the current status of trial NCT05723835?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 47 participants. The study started on 2023-02-01. Estimated completion is 2027-10-29.

What conditions does trial NCT05723835 study?

This clinical trial studies the following conditions: Turner Syndrome, Noonan Syndrome, SGA, ISS.

What interventions are being tested in trial NCT05723835?

The interventions under investigation include: Somapacitan (DRUG).

Who is sponsoring clinical trial NCT05723835?

This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05723835 being conducted?

This trial has 17 study locations across Alabama, California, Colorado, District of Columbia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.