Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Spain / NCT05723835
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 · tracked via the Priya Life Science Spain tracker
Phase
Phase 3
Started
2023-02-01
Last updated
2026-08-13

Condition(s) studied

SGATurner SyndromeNoonan SyndromeISS

Investigational drug(s) / intervention(s)

Somapacitan →

Somapacitan: Somapacitan 0.24 milligrams per kilograms per week (mg/kg/week) will be administered subcutaneously (s.c.) using PDS290 pen-injector.

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.

Eligibility

Sex
ALL
Min age
10 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: Applicable to children with SGA: * Born small for gestational age (birth length below -2 SDS OR birth weight below -2 SDS OR both) (according to national standards). * Age: \- Male participants: Age equal to or above 11.0 years and below 18.0 years at screening. \- Female participants: Age equal to or above 10.0 years and below 18.0 years at screening. * Open epiphyses; defined as bone age less than (\<) 14 years for females and bone age \< 16 years for males. * For Growth Hormone (GH) treatment naïve participants: Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention. Applicable to children with TS: • Diagnosis of TS according to local clinical practice. * Age: \- Female participants: Age equal to or above 10.0 years and below 18.0 years at screening. * Open epiphyses; defined as bone age \< 14 years for females and bone age \< 16 years for males. * For GH treatment naïve participants: Impaired height defined as at least 2.0 standard deviation below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention. * For GH treatment naïve participants: Confirmed diagnosis of TS by 30-cell (or more) lymphocyte chromosomal analysis or confirmation of TS and TS mosaicism using comparative genomic hybridization (CGH)-array. Applicable to children with NS: * Diagnosis of NS according to local clinical practice. * Age: * Male participants: Age equal to or above 11.0 years and below 18.0 years at screening. * Female participants: Age equal to or above 10.0 years and below 18.0 years at screening. * Open epiphyses; defined as bone age \< 14 years for females and bone age \< 16 years for males. * For GH treatment naïve participants: Clinical diagnosis of NS according to van der Burgt score list and genetic test result or confirmed mutation in any of the genes associated with NS before allocation. Applicable to children with ISS: * Age: \- Male participants: Age equal to or above 11.0 years and below 18.0 years at screening. \- Female participants: Age equal to or above 10.0 years and below 18.0 years at screening. * Open epiphyses; defined as bone age \< 14 years for females and bone age \< 16 years for males. * For GH treatment naïve participants: Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and sex at screening * For GH treatment naïve participants: Normal GH secretion (GH peak above 7 ng/mL) during GH stimulation test performed within 18 months prior to screening. * For GH treatment naïve participants: Bone age not delayed more than 2 years compared to chronological age at screening. Exclusion Criteria: * Children with suspected or confirmed growth hormone deficiency according to local practice. * Children diagnosed with diabetes mellitus or screening values from the central laboratory. * Fasting plasma glucose above or equal to 126 milligrams per deciliter (mg/dL) \[7.0 millimoles per litre (mmol/L)\] or * Glycated hemoglobin (HbA1c) above or equal to 6.5%. * Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening. * Children requiring inhaled glucocorticoid therapy at a dose greater than 400 micrograms per day (µg/day) of inhaled budesonide or equivalent (i.e., 250 µg/day for fluticasone propionate) for longer than 4 consecutive weeks within the last 12 months prior to screening. * History or known presence of malignancy including intracranial tumours. Applicable to children with SGA: • Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with height, such as, but not limited to: * Poorly controlled or uncontrolled hormonal deficiencies. * Known chromosomal aneuploidy or significant gene mutations causing medical 'syndromes' with short stature, including but not limited to Laron syndrome, Prader-Willi syndrome, Russell-Silver Syndrome, skeletal dysplasias, abnormal short stature homeobox (SHOX) gene analysis or absence of GH receptors. Applicable to children with TS: • Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with height, such as, but not limited to: * Known family history of skeletal dysplasia. * Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants. * Any other disorder that can cause short stature such as, but not limited to nutritional disorders, chronic systemic illness and chronic renal disease. * Mosaicism below 10%. * TS with Y-chromosome mosaicism where gonadectomy has not been performed. * New York Heart Association (NYHA) class II or above or requiring medication for any heart condition. Applicable to children with NS: • Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with height, such as, but not limited to: * Known family history of skeletal dysplasia. * Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants. * Any other disorder that can cause short stature such as, but not limited to nutritional disorders, chronic systemic illness and chronic renal disease. * Noonan-related disorders including but not limited to: Noonan syndrome with multiple lentigines (formerly called 'LEOPARD' syndrome), Noonan syndrome with loose anagen hair, cardiofaciocutaneous syndrome (CFC), Costello syndrome, neurofibromatosis type 1 (NF1) and Legius syndrome. Applicable to children with ISS: • Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with height, such as, but not limited to: * Known family history of skeletal dysplasia. * Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants. * Any other disorder that can cause short stature such as, but not limited to nutritional disorders, chronic systemic illness and chronic renal disease. * Poorly controlled or uncontrolled hormonal deficiencies. * Known chromosomal aneuploidy or significant gene mutations causing medical 'syndromes' with short stature, including but not limited to Laron syndrome, Prader-Willi syndrome, Russell-Silver Syndrome, skeletal dysplasias, abnormal SHOX gene analysis or absence of GH receptors.

Primary outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
Univ of AL at Birmingham_BRM Birmingham Alabama
Sutter Valley Med Fdt Ped Endo Sacramento California
Rocky Mt Ped and Endo Centennial Colorado
Childrens National Medical Ctr Washington D.C. District of Columbia
Rocky Mt Clin Res, LLC Idaho Falls Idaho
Children's Minnesota Saint Paul Minnesota
University Malaya Medical Centre Lembah Pantai Kuala Lumpur
Hospital Al-Sultan Abdullah UiTM Bandar Puncak Alam Selangor
Erasmus MC Rotterdam Netherlands
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie Rzeszów Podkarpackie Voivodeship
UCK, Klinika Pediatrii, Diabetologii i Endokrynologii, Gdansk Poland
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie Rzeszów Poland
SPSK nr 1 im. prof.S.Szyszko w Zabrzu Zabrze Poland
Pusan National University Yangsan Hospital Yangsan Gyeongsangnam-do
Asan Medical Center Seoul South Korea
Pusan National University Yangsan Hospital Yangsan South Korea
Hospital Vall d'Hebron Barcelona Spain

More Novo Nordisk A/S trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05723835 on ClinicalTrials.gov ↗ ← All trials in Spain