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ACTIVE NOT RECRUITING 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

NCT05723835 · View on ClinicalTrials.gov ↗

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

189 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05723835

The ClinicalTrials.gov registry entry for NCT05723835 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 189 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05723835 reports 17 study locations spanning 10 distinct geographic areas — top geographies include Other, Alabama, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05723835?

The interventions under investigation include: Somapacitan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05723835?

This trial is sponsored by Novo Nordisk A/S, which has 189 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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