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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: Active Phase 3 study of Turner Syndrome and Noonan Syndrome, sponsored by Novo Nordisk A/S.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This outcome measure reported number of AEs in children with short stature for indication SGA. Children with SGA are born small for gestational age with insufficient catch-up growth by 2 years of age or older. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory fi
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2023-02-01 |
| Est. Completion | 2027-10-29 |
| Phase | Phase 3 |
What the registry record for NCT05723835 still lists
NCT05723835 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 516-participant average among 14 other Turner Syndrome trials with a reported enrollment target (91% lower).
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 lists 17 locations in 10 states (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.
Learn More About Clinical Trials
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Where NCT05723835's enrollment target sits among peer trials
47 12th of 14 higher than 3 of 14 other Turner Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Turner Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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